EUROPEAN COMMISSION
HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL
Directorate D - Food Safety: Production and distribution chain
Unit D.3 - Chemicals, contaminants and pesticides
MCPA
SANCO/4062/2001-rev. 5
07 April 2005
EU RESTRICTED
COMMISSION WORKING DOCUMENT - DOES NOT NECESSARILY REPRESENT
THE VIEWS OF THE COMMISSION SERVICES
DRAFT
Review report for the active substance MCPA
Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on
15 April 2005
in view of the inclusion of MCPA in Annex I of Directive 91/414/EEC
1.
Procedure followed for the re-evaluation process
This review report has been established as a result of the re-evaluation of MCPA, made in the
context of the work programme for review of existing active substances provided for in Article
8(2) of Directive 91/414/EEC concerning the placing of plant protection products on the market,
with a view to the possible inclusion of this substance in Annex I to the Directive.
Commission Regulation (EEC) No 3600/92(1) laying down the detailed rules for the
implementation of the first stage of the programme of work referred to in Article 8(2) of Council
Directive 91/414/EEC, as last amended by Regulation (EC) No 2266/2000(2), has laid down the
detailed rules on the procedure according to which the re-evaluation has to be carried out.
MCPA is one of the 90 existing active substances covered by this Regulation.
In accordance with the provisions of Article 4 of Regulation (EEC) No 3600/92, Law Offices of
Samuel Pisar (now Nufarm UK Limited) on 25 June 1993, Rhône-Poulenc Agro on 15 July
1993, BASF AG on 13 July 1993, Agrolinz on 26 July 1003, ACI International (on behalf of
Sanachem International) on 30 July 1993, CFPI on 28 July 1993, Akzo Chemicals on 20 July
1993, AH Marks & Co Ltd on 20 July 1993, B.V. Luxan on 21 July 1993 and Esbjerg Kemi A/S
on 21 July 1993 notified to the Commission of their wish to secure the inclusion of the active
substance MCPA in Annex I to the Directive.
In accordance with the provision of art. 4 of Regulation (EEC) No 3600/92, Sipcam-Ooxon
(now Oxon Italia S.p.A) on 20 July 1993 notified to the Commission of their wish to secure the
1
OJ No L 366, 15.12.1992, p.10.
2
OJ No L 259, 13.10.2000, p.27.
inclusion of the active substance MCPA–thioethyl ester in Annex I to the Directive, as
confirmed on 10 October 1994 to RMS.
In accordance with the provisions of Article 4 of Regulation (EEC) No 3600/92, Industry Task
Force on MCPA Research Data, comprising BASF AG, Nufarm UK Limited (leading the task
force) and it affiliates Agrolinz and Akzo Chemicals, and AH Marks, notified to the
Commission on 25 October 1994 of their wish to secure the inclusion of the active substance
MCPA in Annex I to the Directive.
On 25 June 1994, Rhône-Poulenc Agro informed the Commission about the transfer of their
business on MCPA to Nufarm UK Limited. CFPI informed, on 1st November 1994, the
withdrawal of their notification. The same information was given by B.V. Luxan on 06
December 1994.
In accordance with the provisions of Article 5 of Regulation (EEC) No 3600/92, the
Commission, by its Regulation (EEC) No 933/94(3), as last amended by Regulation (EC) No
2230/95(4), designated Italy as rapporteur Member State to carry out the assessment of MCPA
on the basis of the dossier/s submitted by the notifier/s. In the same Regulation, the Commission
specified furthermore the deadline for the notifiers with regard to the submission to the
rapporteur Member States of the dossiers required under Article 6(2) of Regulation (EEC) No
3600/92, as well as for other parties with regard to further technical and scientific information;
for MCPA this deadline was 31 October 1995.
The Industry Task Force on MCPA Research Data (comprising BASF, Nufarm and its affiliates
Agrolinz and Akzo Chemicals, and AH Marks), as well as Oxon Italia SpA (which submitted
information on MCPA thioethyl ester and got access to MCPA data by Agrolinz on 10 Jaunary
1995) and Sanachem (which, in December 1997, has been purchased by Dow Agrosciences, a
member of the Industry Task Force on MCPA Research Data) each submitted dossiers to the
rapporteur Member State which did not contain substantial data gaps, taking into account the
supported uses. Therefore, Nufarm, being the designated representative of the MCPA task force,
and Oxon Italia SpA (MCPA thioethyl ester) were considered to be the main data submitters.
In accordance with the provisions of Article 7(1) of Regulation (EEC) No 3600/92, Italy
submitted on 5 April 2001 to the Commission the report of its examination, hereafter referred to
as the draft assessment report, including, as required, a recommendation concerning the possible
inclusion of MCPA in Annex I to the Directive. Moreover, in accordance with the same
provisions, the Commission and the Member States received also the summary dossier on
MCPA from Industry Task Force on MCPA Research Data and MCPA thioethyl ester from
Oxon Italia SpA, on 20 December 2001.
In accordance with the provisions of Article 7(3) of Regulation (EEC) No 3600/92, the
Commission forwarded for consultation the draft assessment report to all the Member States as
well as to Nufarm, designated representative(s) of the MCPA task force, and Oxon Italia SpA
being the main data submitters, on 23 May 2001.
The Commission organised an intensive consultation of technical experts from a certain number
of Member States, to review the draft assessment report and the comments received thereon
(peer review), in particular on each of the following disciplines:
3
OJ No L 107, 28.04.1994, p.8.
4
OJ No L 225, 22.09.1995, p.1.
-
identity and physical /chemical properties ;
fate and behaviour in the environment ;
ecotoxicology ;
mammalian toxicology ;
residues and analytical methods ;
regulatory questions.
The meetings for this consultation were organised on behalf of the Commission by the Pesticide
Safety Directorate (PSD) in York, United Kingdom, from February to September 2002.
The report of the peer review (i.e. full report) was circulated, for further consultation, to Member
States and the main data submitters, Industry Task Force on MCPA Research Data (MCPA) and
Oxon Italia S.p.A. (MCPA thioethyl ester), on 11 October 2002 for comments and further
clarification.
In accordance with the provisions of Article 7(3) of Regulation (EEC) No 3600/92, the dossier,
the draft assessment report, the peer review report (i.e. full report) and the comments and
clarifications on the remaining issues, received after the peer review were referred to the
Standing Committee on the Food Chain and Animal Health, and specialised working groups of
this Committee, for final examination, with participation of experts from all Member States.
This final examination took place from February 2002 to December 2004, and was finalised in
the meeting of the Standing Committee on 15 April 2005.
The review did not reveal any open questions or concerns which would have required a
consultation of the Scientific Committee on Plants.
The present review report contains the conclusions of the final examination; given the
importance of the draft assessment report, the peer review report (i.e. full report) and the
comments and clarifications submitted after the peer review as basic information for the final
examination process, these documents are considered respectively as background documents A,
B and C to this review report and are part of it.
2.
Purposes of this review report
This review report, including the background documents and appendices thereto, has been
developed and finalised in support of the Directive 2005/57/EC concerning the inclusion of
MCPA in Annex I to Directive 91/414/EEC, and to assist the Member States in decisions on
individual plant protection products containing MCPA they have to take in accordance with the
provisions of that Directive, and in particular the provisions of article 4(1) and the uniform
principles laid down in Annex VI.
This review report provides also for the evaluation required under Section A.2.(b) of the above
mentioned uniform principles, as well as under several specific sections of part B of these
principles. In these sections it is provided that Member States, in evaluating applications and
granting authorisations, shall take into account the information concerning the active substance
in Annex II of the directive, submitted for the purpose of inclusion of the active substance in
Annex I, as well as the result of the evaluation of those data.
In accordance with the provisions of Article 7(6) of Regulation (EEC) No 3600/92, Member
States will keep available or make available this review report for consultation by any interested
parties or will make it available to them on their specific request. Moreover the Commission will
send a copy of this review report (not including the background documents) to all operators
having notified for this active substance under Article 4(1) of this Regulation.
The information in this review report is, at least partly, based on information which is
confidential and/or protected under the provisions of Directive 91/414/EEC. It is therefore
recommended that this review report would not be accepted to support any registration outside
the context of Directive 91/414/EEC, e.g. in third countries, for which the applicant has not
demonstrated to have regulatory access to the information on which this review report is based.
3.
Overall conclusion in the context of Directive 91/414/EEC
The overall conclusion from the evaluation is that it may be expected that plant protection
products containing MCPA will fulfil the safety requirements laid down in Article 5(1)(a) and
(b) of Directive 91/414/EEC. This conclusion is however subject to compliance with the
particular requirements in sections 4, 5, 6 and 7 of this report, as well as to the implementation
of the provisions of Article 4(1) and the uniform principles laid down in Annex VI of Directive
91/414/EEC, for each MCPA containing plant protection product for which Member States will
grant or review the authorisation.
These conclusions were reached, in particular, for the acid of MCPA for which detailed
information has been submitted. Further studies, in particular bridging studies, may be necessary
in relation to the acceptance of salts or esters of MCPA (including MCPA-thioethyl) other than
the acid evaluated.
Furthermore, these conclusions were reached within the framework of the uses which were
proposed and supported by the main data submitter and mentioned in the list of uses supported
by available data (attached as Appendix IV to this Review Report).
Extension of the use pattern beyond those described above will require an evaluation at Member
State level in order to establish whether the proposed extensions of use can satisfy the
requirements of Article 4(1) and of the uniform principles laid down in Annex VI of Directive
91/414/EEC.
With particular regard to residues, the review has established that the residues arising from the
proposed uses, consequent on application consistent with good plant protection practice, have no
harmful effects on human or animal health. The Theoretical Maximum Daily Intake (TMDI;
excluding water and products of animal origin) for a 60 kg adult is 36.2 % of the Acceptable
Daily Intake (ADI), based on the FAO/WHO European Diet (August 1994). Additional intake
from water and products of animal origin are not expected to give rise to intake problems.
The review has identified several acceptable exposure scenarios for operators, workers and
bystanders, which require however to be confirmed for each plant protection product in
accordance with the relevant sections of the above mentioned uniform principles.
The review has also concluded that under the proposed and supported conditions of use there are
no unacceptable effects on the environment, as provided for in Article 4 (1) (b) (iv) and (v) of
Directive 91/414/EEC, provided that certain conditions are taken into account as detailed in
section 6 of this report.
4.
Identity and Physical/chemical properties
The main identity and the physical/chemical properties of MCPA and MCPA-thioethyl are given
in Appendix I.
The active substance shall comply with the FAO specification and there seem not to be reasons
for deviating from that specification; the FAO specification is given in Appendix I of this report.
The review has established that for the active substances notified by the main data submitters,
the Industry Task Force on MCPA Research Data and Oxon Italia SpA, none of the
manufacturing impurities considered are, on the basis of information currently available, of
toxicological or environmental concern.
In accordance with the provisions of Article 13(5) of Directive 91/414/EEC, Italy is also
satisfied, on the basis of the information currently available, that the substances notified by the
other data submitters Sanachem do not, in the meaning of Article 13(2) and (5) of the Directive,
differ significantly in degree of purity and nature of impurities from the composition registered
in the dossier submitted by the main data submitter.
5.
Endpoints and related information
In order to facilitate Member States, in granting or reviewing authorisations, to apply adequately
the provisions of Article 4(1) of Directive 91/414/EEC and the uniform principles laid down in
Annex VI of that Directive, the most important endpoints were identified during the reevaluation process. These endpoints are listed in Appendix II.
6.
Particular conditions to be taken into account on short term basis by Member
States in relation to the granting of authorisations of plant protection products
containing MCPA
On the basis of the proposed and supported uses (as listed in Appendix IV), the following
particular issues have been identified as requiring particular and short term attention from all
Member States, in the framework of any authorisations to be granted, varied or withdrawn, as
appropriate:
-
Member States must pay particular attention to the protection of aquatic organisms
and must ensure that the conditions of authorisation include, where appropriate,
risk mitigation measures.
7.
List of studies to be generated
No further studies were identified which were at this stage considered necessary in relation to the
inclusion of MCPA in Annex I under the current inclusion conditions.
Some endpoints however may require the generation or submission of additional studies to be
submitted to the Member States in order to ensure authorisations for use under certain
conditions. This may particularly be the case for additional bridging studies in relation to the
acceptance of salts and esters of MCPA (including MCPA-thioethyl) other than the acid which
was evaluated.
8.
Information on studies with claimed data protection
For information of any interested parties, Appendix III gives information about the studies for
which the main data submitter has claimed data protection and which during the re-evaluation
process were considered as essential with a view to annex I inclusion. This information is only
given to facilitate the operation of the provisions of Article 13 of Directive 91/414/EEC in the
Member States. It is based on the best information available to the Commission services at the
time this review report was prepared; but it does not prejudice any rights or obligations of
Member States or operators with regard to its uses in the implementation of the provisions of
Article 13 of the Directive 91/414/EEC neither does it commit the Commission.
9.
Updating of this review report
The technical information in this report may require to be updated from time to time in order to
take account of technical and scientific developments as well as of the results of the examination
of any information referred to the Commission in the framework of Articles 7, 10 or 11 of
Directive 91/414/EEC. Such adaptations will be examined and finalised in the Standing
Committee on the Food Chain and Animal Health, in connection with any amendment of the
inclusion conditions for MCPA in Annex I of the Directive.
-1MCPA
APPENDIX I
Identity, physical and chemical properties
05 April 2005
APPENDIX I
Identity, physical and chemical properties
MCPA
MCPA-acid
MCPA
Common name (ISO)
MCPA-thioethyl
MCPA technical acid
MCPA-thioethyl (BSI, EISO)
2,4-MCPA (France)
Phenothiol (JMAF)
Chemical name (IUPAC)
4-chloro-o-tolyoxyacetic
acid
S-ethyl 4 chloro-otolyloxythioacetate
Chemical name (CA)
(4-chloro-2
methylphenoxy) acetic
acid
S-ethyl (4-chloro2methylphenoxy)ethaneth
ioate
CIPAC No
2
not available
CAS No
94-74-6
25319-90-8
EEC No
202-360-6
not available
FAO SPECIFICATION
 930 g/kg  15 g/kg
(1994)
not available
Minimum purity
930 g/Kg minimum
920 g/Kg minimum
Molecular formula
C9H9ClO3
C11H13ClO2S
Molecular mass
200.6
244.7
Structural formula
Cl
OCH2COOH
CH3
OCH2COSCH2CH3
Cl
CH
3
MCPA
-2-
APPENDIX I
Identity, physical and chemical properties
05 April 2005
MCPA-acid
MCPA-thioethyl
Melting point
115.4°C to 116.8°C Purity
= 99.5%
41°C to 41.5°C Purity
100%
Boiling point
Decomposition is observed Not determinable
at approx. 290°C
Appearance
Pure: White Solid
Solid Purity = 100%
Technical: Off white solid
Relative density
D4 20 = 1.410 Purity 99.9%
1291 Kg/m3 at 22°C Purity
100%
Vapour pressure
4 x 10-4 Pa at 32°C; 4 x 10- 1.30 x 10-2 Pa at 25°C
3
Pa at 45°C Purity 99.4% Purity 100%
Henry's law constant
5.5 x 10-5 Pa.m3/mol at
25°C
2.102 x 10-1 Pa.m3/mol at
25°C
Solubility in water
Unbuffered(pH1) 0.395g/l
at 25°C
2.28 mg/l at 20°C
Purity 100%
pH5: 26.22 g/l at 25°C
pH7: 293.90 g/l at 25°
pH9:320.09 g/l at 25°C
Purity 99.4%
Solubility in organic solvents
Solvent
Solubility at 25°C g/l
Solvent
Solubility at 25°C g/l
Toluene
26.5
Acetone
>1000
Dichloromethane
69.2
Methanol
144
Methanol
775.6
Dichloromethane
>1000
Propanol-2
425.6
Ethyl acetate
>1000
Acetone
487.8
n-hexane
369
Ethylacetate
289.3
Xylene
>1000
n-Hexane
0.323
Purity 100%
n-Octanol
218.3
Purity = 99.4 %
MCPA
-3-
Partition co-efficient (log Pow)
APPENDIX I
Identity, physical and chemical properties
05 April 2005
pH1: 2.70 (0.001 Mol/l);
2.80 (0.0001 Mol/l)
4.45 at 25°C
Purity 100%
pH5: 0.28 (0.01 m/l); 0.59
(0.001 m/l)
pH7: -0.81 (0.01 m/l); 0.71 (0.001 m/l)
pH9: -1.07 (0.01 m/l); 0.88 (0.001 m/l)
Purity 99.4%
Hydrolytic stability (DT50)
14
C-MCPA acid was stable pH1: DT50 = 5.42 days at
to hydrolytic degradation
37°
at pH 5, 7 and 9 at
pH4: DT50 = 35.58 days at
25°C for 30 days.
25°C; 11.92 days at 40°C
pH7: DT50 = 10.90 days at
25°C; 2.21 days at 40°C
pH9: DT50 = 8.69 hours at
25°C; 1.14 hours at 40°C
Purity 100%
Dissociation constant
pKa = 3.73 (s = 0.07) at
20°C
Not determinable
pKa = 3.73 (s = 0.00) at
25°C
Quantum yield of direct phototransformation in water at  >290
nm
Estimated Quantum
efficiency   0.093
The quantum yield of
Phenothiol was
The wavelength applied in determined to be 8.3 x 102 at pH 7
this test was 304nm.
Purity = 99.0 %
Purity 93.4%
Flammability
MCPA technical acid is not Not flammable
considered highly
Technical purity = 93.8 %
flammable
Explosive properties
Study not required
Not explosive. Purity
93.8%
UV/VIS absorption (max.)
No absorption > 290 nm
No absorption > 290 nm
Photostability in water (DT50)
DT50 (aqueous) 25.4 days
Artificial light: DT50 (buffer
solution) 17.8 hours
Artificial light: DT50 (river
water) 14.8 hours
Natural light DT50 (buffer
solution) 74.1 hours
Natural light DT50 (river
water) 61.6 hours
-3MCPA
APPENDIX II
END POINTS AND RELATED INFORMATION
1. Toxicology and metabolism
05 April 2005
APPENDIX II
END POINTS AND RELATED INFORMATION
MCPA
1 Toxicology and metabolism
Absorption, distribution, excretion and metabolism in mammals
MCPA
Rate and extent of absorption:
rapidly absorbed 75 % in
96 h, 40% in 12 h; Tmax
2-2,4 h in rats; 58 % in
120 h (5mg/kg) Tmax
4,54 h in dogs
MCPA-thioethyl
rapidly absorbed > 90%
in 24 hrs Tmax 2-4 h in
rats
55 % in 96 h (15
ug/kg/bw ) Tmax 1 h in
humans
Distribution:
uniformly distributed
uniformly distributed
Potential for accumulation:
not potential for
accumulation
not potential for
accumulation
Rate and extent of excretion:
Rapidly excreted
in rats 90 % in 48 hrs,
mainly in urine
in dogs 58 % (5mg/kg)
34% (100 mg/kg) in 120
hrs in urine
in humans 51,5% at 5
mg/kg in 48 hrs in urine
Toxicologically significant compounds:
MCPA
Metabolism in animals:
70 - 90 % as unchanged 80% excreted as MCPA
MCPA in the urine; 2-7% (rat 5 and 100 mg/kg)
HMCPA (hydroxymethylderivative); traces of
glycine conjugate in rats,
30 % unchanged MCPA,
6,5% HMCPA 12-38%
glycine conjugates in dogs
In humans high level of
conjugation may occur
(56-73 % conjugates in a
volunteer)
MCPA
-4MCPA
APPENDIX II
END POINTS AND RELATED INFORMATION
1. Toxicology and metabolism
05 April 2005
Acute toxicity
MCPA
MCPA-thioethyl
Rat LD50 oral:
962 mg/kg b.w. female
450 mg/kg b.w.
Rat LD50 dermal:
> 4000 mg/kg b.w.
5000 mg/kg b.w.
Rat LC50 inhalation:
>6.36 mg/l 4h (head-nose; provided, to be dealt with
dust aerosol)
at MS level
Skin irritation:
non irritant
non irritant
Eye irritation:
severe irritant
non irritant
Skin sensitization (test method used
and result):
non-sensitizer
non-sensitizer
Short term toxicity
MCPA
MCPA-thioethyl
Target / critical effect:
kidney/blood
kidney/blood
Lowest relevant oral NOAEL / NOEL:
NOAEL = 4,2 mg/kg/bw ( 2.2 mg/kg/bw (rat 90 days
90 day study in rats)
study)
Lowest relevant dermal NOAEL /
NOEL: (systemic toxicity)
1000 mg/kg b.w. 21 days
study in rabbit
to be dealt with at MS
level
Lowest relevant inhalation NOAEL /
NOEL:
not requested
not requested
Genotoxicity
no relevant genotoxic
potential in vitro and in
vivo.
no mutagenic potential in
vitro tests.
Long term toxicity and carcinogenicity
MCPA
MCPA-thioethyl
Target / critical effect:
kidney/blood
kidney, growth reduction
Lowest relevant NOEL / NOAEL:
NOEL = 1.25 mg/kg b.w.;
rat, 2 years
0.95 mg/kg b.w.; rat, 2
years
Carcinogenicity:
no carcinogenic potential.
Studies are available for
both compounds.
no carcinogenic potential.
Studies are available for
both compounds.
-5MCPA
APPENDIX II
END POINTS AND RELATED INFORMATION
1. Toxicology and metabolism
05 April 2005
Reproductive toxicity
MCPA
MCPA-thioethyl
Target / critical effect - Reproduction:
Reduced body weight
gain of pups at parentally
toxic doses
MCPA -thioethyl reduced
body weight gain in adults
Lowest relevant reproductive NOAEL /
NOEL:
150 ppm (8 mg/kg bw/d;
rat 2-generation study)
500 ppm (approx. 25
mg/kg b.w.; rat; 2generation)
Target / critical effect - Developmental
toxicity:
Maternal toxicity
Maternal toxicity
Lowest relevant developmental
NOAEL / NOEL:
15 mg/kg b.w. (rabbit
maternal toxicity)
40 mg/kg /bw (rat and
rabbit maternal toxicity)
Delayed neurotoxicity
no neurotoxicity
no neurotoxicity
Other toxicological studies
None
None
Medical data
No overall increase in
cancer risk. or, risk for
NHL and soft tissue
sarcomas in
manufacturing workers
exposed to dioxin-free
phenoxy herbicides.
None
-6MCPA
APPENDIX II
END POINTS AND RELATED INFORMATION
1. Toxicology and metabolism
05 April 2005
Summary*
Value
Study
Safety factor
ADI:
0.013
2 years, rat
100
AOEL systemic:
0. 04
90 days study in 100
rats
As above
AOEL inhalation:
Not needed
AOEL dermal:
Not needed
ARfD (acute reference dose):
0.08
(if ARfD is required, please provide
also information on dietary intake for
children, e.g. NESTI
15 mg/kg dev
study in rabbit
100
NESTI:
Cereals - 1 % of
ARfD for
toddlers, 0.3%
for adults;
Pears – 1.8% of
ARfD for adults,
6,5 % for
toddlers;
Apples – 1.7% of
ARfD for adults,
8.5% for toddlers
*endpoints based on MCPA dossier
MCPA
Dermal absorption
MCPA-thioethyl
2.2% from the concentrate 10 % default pending
and 2.5% of spray
classification based on
strength dilution based on formulations
new in vivo and in vitro
studies
MCPA
APPENDIX II
END POINTS AND RELATED INFORMATION
2. Fate and behaviour in the environment
05 April 2005
-7-
2 Fate and behaviour in the environment
2.1 Fate and behaviour in soil
Route of degradation
Aerobic:
Mineralization after 100 days:
Non-extractable residues after 100 days:
MCPA
91 days: 54% (route
study)
209 days: 67% of total
amount of radioactivity
applied was recovered
as 14CO2
91 days: 34.4% (route
study)
209 days: 30% of total
amount of radioactivity
applied was found as
soil-bound residues
Major metabolites above 10 % of applied
active substance: name and/or code
% of applied rate (range and maximum)
4 minor components.
MCPA-thioethyl
The study was
conducted for a 25
days period at 30 °C.
2.8% max of CO2 was
formed
To be dealt with at MS
level.
MCPA: max 66% after
2 days
2-methyl-4chlorophenol potentially 2-methyl-4relevant minor
chlorophenol: max
metabolite
19.8% after 12 days
MCPA
Supplemental studies
MCPA-thioethyl
Anaerobic:
MCPA is practically not
degraded under
anaerobic conditions
To be dealt with at MS
level.
Soil photolysis:
It is not a mayor route To be dealt with at MS
of MCPA degradation. level.
In natural sunlight DT50
ranges from 9 to 67
days.
Remarks:
None
None
MCPA
APPENDIX II
END POINTS AND RELATED INFORMATION
2. Fate and behaviour in the environment
05 April 2005
-8-
Rate of degradation
Laboratory studies
MCPA
MCPA-thioethyl
DT50lab (20 °C, aerobic):
DT50lab (20C, aerobic): DT50lab: (20°C) 4.4 days
range from 7 to 41 days estimated from route study
(n = 3).
(14 soils, data from
literature). The DT50
value of 24 days (25°C)
chosen for PECsoil
calculations was
obtained from the route
of degradation study.
DT90lab (25 °C, aerobic):
79 days (from the route To be dealt with at MS
of degradation study)
level.
DT50lab (10 °C, aerobic):
78 days (calculated
value)
To be dealt with at MS
level.
DT50lab (20 °C, anaerobic):
DT50lab (20C,
anaerobic): no
degradation
To be dealt with at MS
level.
Field studies (country or region)
MCPA
MCPA-thioethyl
DT50f from soil dissipation studies:
not required
DT50f not required
DT90f from soil dissipation studies:
not required
DT90f: not required
Soil accumulation studies:
Not required
Not required
Soil residue studies:
Not required
Not required
Remarks:
None determined.
MCPA is essentially
fully ionised at
environmentally
relevant pH so none
expected.
Not determined
e.g. effect of soil pH on degradation rate
MCPA
APPENDIX II
END POINTS AND RELATED INFORMATION
2. Fate and behaviour in the environment
05 April 2005
-9-
Adsorption/desorption
MCPA
MCPA-thioethyl
Kf / Koc:
Soils 8 (USA)
Kd:
Kf 0.21 - 1.11
1/n: To be dealt with at MS
0.50 – 0.72 (mean level.
value 0.68)
Koc 10 - 157 (mean
value 74)
Kd 0.05 - 1.99
Active substance:
Metabolites
MCPA: Koc = 74. (data
from MCPA
monograph)
2-methyl-4chlorophenol: no data
are submitted. Data
required, to be dealt
with at MS level
pH dependence:
Yes (less adsorption
To be dealt with at MS
when pH increases, this level.
effect is likely to be
significant only at pH
values < about 4)
Mobility
Laboratory studies:
MCPA
MCPA-thioethyl
Column leaching:
No data available
To be dealt with at
national level
Aged residue leaching:
The radioactivity of
to be dealt with at MS
aged MCPA residues
level.
was concentrated in the
top soil layer. Leachate
contamination: less
than 1% of TAR.
MCPA
- 10 -
APPENDIX II
END POINTS AND RELATED INFORMATION
2. Fate and behaviour in the environment
05 April 2005
Field studies:
Lysimeter/Field leaching studies:
Less than 0.5% of
To be dealt with at MS
MCPA residues were
level.
detected in the
percolate in a 2 year
period. Most of the
residue (about 80% of
the total found) was
detected in the top soil
layer 0-10 cm after 735
days.
Remarks:
None
None
MCPA
- 11 -
APPENDIX II
END POINTS AND RELATED INFORMATION
2. Fate and behaviour in the environment
05 April 2005
2.2 Fate and behaviour in water
MCPA
Abiotic degradation
Hydrolytic degradation:
C – MCPA is stable for 30
days in sterile aqueous
buffered solutions at pH 5, 7
and 9 at 25°C
14
MCPA-thioethyl
Active substance: A
study has been
submitted and it is
under evaluation.
To be dealt with at MS
level
Metabolites
MCPA: is stable for 30
days in sterile aqueous
buffered solutions at pH
5, 7 and 9 at 25°C
(data from MCPA
monograph)
2-methyl-4chlorophenol: no data
are submitted. Data
required, to be dealt
with at MS level
Major metabolites:
None
MCPA
Photolytic degradation:
MCPA degraded rapidly in
aqueous solutions buffered at
pH 5 (88 min),.7 (69 min) and
9 (97min) under artificial
sunlight irradiation conditions.
Active substance:
Provided, to be dealt
with at MS level.
In natural sunlight the 14CMCPA DT50 was calculated to
be 25.4 days in sterile aqueous
buffer at pH=5, based on
pseudo-first order kinetics.
2-methyl-4-chlorophenol,
which represented 11.6% of
the applied dose, is the major
photodegradation product.
Metabolites
MCPA: at pH 5 (88
min),.7 (69 min) and 9
(97min) under artificial
sunlight
irradiation
conditions. In natural
sunlight MCPA DT50
was calculated to be
25.4 days in sterile
aqueous buffered at
pH=5 (data from MCPA
monograph)
2-methyl-4chlorophenol: no data
are submitted.
Major metabolites:
Biological degradation
Readily biodegradable:
2-methyl-4-chlorophenol
MCPA
Not readily biodegradable.
MCPA-thioethyl
Not readily
biodegradable
MCPA
- 12 -
Water/sediment study:
DT50 water:
DT90 water:
DT50 whole system:
DT90 whole system:
APPENDIX II
END POINTS AND RELATED INFORMATION
2. Fate and behaviour in the environment
05 April 2005
(mean of 2 sediments)
To be dealt with at MS
level.
13.5 days
44.7 days
16.9 days
56.2 days
Distribution in water / sediment
systems
(active substance)
63% of applied dose was
converted to CO2 in 84 days.
Less than 20% was detected in
the sediment system.
Distribution in water / sediment
systems
(metabolites)
Only CO2 was identified as a
significant metabolite
Accumulation in water and/or sediment:No accumulation of parent or
metabolites
Provided, To be dealt
with at MS level.
To be dealt with at MS
level.
Degradation in the saturated
zone
Not required
Not required
Remarks:
None
None
MCPA
APPENDIX II
END POINTS AND RELATED INFORMATION
2. Fate and behaviour in the environment
05 April 2005
- 13 -
2.3 Fate and behaviour in air
MCPA
MCPA-thioethyl
Vapour pressure:
4 x 10-4 Pa at 32°C; 4 x
10-3 Pa at 45°C Purity
99.4%
1.30 x 10-2 Pa at 25°C
Purity 100%
Henry's law constant:
5.5 x 10-5 Pa.m3/mol at
25°C
2.102 x 10-1 Pa.m3/mol
at 25°C
Direct photolysis in air:
Degradation rate from
OH-attack was found to
be kOH = 12.6257  10-12
cm3 molecule-1 s-1.
Based on this value the
atmospheric
degradation half-life was
0.78 d
Due to the low Henry’s
law constant of MCPAThioethyl, equivalent to
8.48 x 10-5 Pa at 25 °
the study is deemed
unnecessary
Photochemical oxidative degradation in air
Not measured. Low
To be dealt with at MS
volatility of MCPA
level.
means that
atmospheric
accumulation is unlikely
Volatility
Photolytic degradation
DT50:
Volatilisation:
Remarks:
from plant surfaces: No No significant loss is
data, low volatility of
expected.
MCPA means that no
significant loss is
expected.
from soil: No data low
volatility of MCPA
means that no
significant loss is
expected.
No significant loss is
expected.
None
None
- 14 MCPA
APPENDIX II
END POINTS AND RELATED INFORMATION
3. Ecotoxicology
05 April 2005
3 Ecotoxicology
Terrestrial Vertebrates
MCPA
MCPA-thioethyl
Acute toxicity to mammals:
LD50 962 mg/kg bw
(rat)
14d LD50 450 mg/kg
bw (rat)
Acute toxicity to birds:
LD50 bobwhite quail =
270 mg/kg
LD50 >400 mg as/kg
bw (bobwhite quail).
Phenothiol (20%)
Dietary toxicity to birds:
LC50 >5620 mg.as/kg
diet (>983 mg/kg/day)
LC50 >1040 mg as /kg
diet (Bobwhite quail).
Phenothiol (20%)
NOEC 562 mg.as/kg
diet, Mallard duck)
Reproductive toxicity to birds:
NOEC 1000 ppm
(bobwhite quail)*
To be dealt with at MS
level.
Equivalent to a mean
intake of 93.2 mg/kg
bwt/day
Short term oral toxicity to mammals:
NOAEL = 37.8 mg/kg
bwt/day (from 90 day
rat study at 450 ppm)
To be dealt with at MS
level.
Aquatic Organisms
MCPA
Acute toxicity fish:
MCPA-thioethyl
Species
Time
scale
Toxicity
(mg/l)
End
point
Species
Time
scale
Toxicity
(mg/l)
End point
Oncorh
ynchus
mykiss
96 h
50 mg
a.i.* /l
LC50
Oncorhync
hus mykiss
96 h
0.3 mg
as/l
LC50
Salmo
gairneri
96h
0.75 mg
as/l
LC50
Salmo
gairneri
28 d
0.2 mg
as/l
NOEC
Long term toxicity
fish:
Pimeph
ales
promela
s
Bioaccumulation
fish:
Not
required
log P <
3
Flow
through
28 days
Flow
through
15 mg
a.i./l
NOEC
Not
provided
- 15 MCPA
Acute toxicity
invertebrate:
APPENDIX II
END POINTS AND RELATED INFORMATION
3. Ecotoxicology
05 April 2005
Daphnia
magna
48 h
Flow
trough
Chronic toxicity
invertebrate:
Daphnia
magna
21 days
Acute toxicity
algae:
Selenas
trum
capricor
nutum
120 h
Flow
trough
>190
mg a.i. /l
EC50
Daphnia
magna
48 h
0.58 mg
as/l
EC50
Daphnia
magna
48 h
0.072
mg as/l
EC50
50 mg
a.i*. /l
NOEC
Daphnia
magna
21 d
0.009
mg as/l
NOEC
79.8 mg
a.i. /l
(cell
density)
EC50
Scenedes
mus
subspicatu
s
72 h
>2.3 mg
as/l
ErC50
Selenastru
m
capricornut
um
72 h
0.92 mg
as/l
EbC50
Growth
inhibition
>392
mg a.i. /l
(growth
rate)
Navicul
a
pelliculo
sa
120 h
32.9 mg
a.i. /l
(cell
density)
EC50
117 mg
a.i. /l
(growth
rate)
Chronic toxicity
sediment dwelling
organism:
Not
Require
d
Acute toxicity
aquatic plants:
(for herbicides
only)
Lemna
gibba
G3
Not
required
14 d
152 µg
a.i./l
IC50
To be dealt
with at MS
level.
* ai for these aquatic end points is MCPA DMA
Honeybees
MCPA
MCPA-thioethyl
Acute oral toxicity:
LD50 >200g/bee
LD50 >100µg
formulation/bee(Pheno
thiol 20% EC)
Acute contact toxicity:
LD50 >200g/bee
LD50 >100µg
formulation /bee
(Phenothiol 20% EC)
- 16 MCPA
APPENDIX II
END POINTS AND RELATED INFORMATION
3. Ecotoxicology
05 April 2005
Other arthropod species
Test species
MCPA
Application
MCPA-thioethyl
Stage
Effects/Endpoint
(kg.as/ha)
Pardosa spp
2
Adult/
subadult
0%
Mortality(harmle
ss)
Aphidius
rhopalosiphi
2Tier 1 test
Adult
100%
Mortality
Provided. To
be dealt with
at MS level.
Aphidius
rhopalosiphi
2,1, 0.025
0 % Mean
corrected
Mortality
Provided. To
be dealt with
at MS level.
Tier 2 test
on barley
seedlings
Adult
Typhlodromu
s pyri
0.2, 2 L/ha
Protony
mphs/
adult
0%
Mean corrected
Mortality
(harmless)
Provided. To
be dealt with
at MS level.
Chrysoperla
carnea
4 L/ha
Larvae/a
dult
0 % Mean
corrected
Mortality
Provided. To
be dealt with
at MS level.
- 0.8
Reproduction
factor
Reproduction
unaffected (R =
1.00)
- 17 MCPA
APPENDIX II
END POINTS AND RELATED INFORMATION
3. Ecotoxicology
05 April 2005
Earthworms
MCPA
MCPA-thioethyl
Acute toxicity:
14 d LC50 325 mg
as/kg dry soil
14 d LC50 140.5 mg
as/kg soil
Reproductive toxicity:
Not required
Not required
Soil micro-organisms
Nitrogen mineralization:
No effect (28 days) at 2.67 mg
a.i./kg dry wt. soil corresponding
to the highest recommended rate
of application (2kg/ha) and at
26.7 mg a.i./kg dry.wt. soil
corresponding to 10-x the
highest recommended rate of
application (20 kg as /ha).
(ammonification and nitrification)
<25% of deviation at
1.224 kg as/ha (28 days)
Carbon mineralization:
No effect (28 days) at 2.67 mg
a.i./kg dry.wt. soil corresponding
to the highest recommended rate
of application (2kg/ha) and at
26.7 mg a.i./kg dry.wt. soil
corresponding to 10-xf the
highest recommended rate of
application (20 kg as /ha).
(respiration)
<25% of deviation at
1.224 kg as/ha (28 days)
- 18 MCPA
APPENDIX IIIA
List of studies
05 April 2005
APPENDIX IIIA
MCPA
List of studies for which the main submitter has claimed data protection
and which during the re-evaluation process were considered as essential
for the evaluation with a view to Annex I inclusion.
B.1 Identity, B.2 Physical and chemical properties, B.3 Data on application and further information,
B.4 Proposals for classification and labelling, B.5 Methods of analysis
Annex
point/
reference
number
Author(s)
Year
IIA 2.2.1
Chakrabarti, A
1985 Vapor Pressure of MCPA and two
MCPA Esters
La Bean, M S
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Reports5 on
previous use in
granting
national
authorizations
MS Generated by: Dow Chemical Co
Submitted by: MCPA Dossier
Preparation Working Group
Report No: ML-AL-85-40005
GLP: No
unpublished
IIA 2.8.2
Concha M
IIA
Shepler K
7.2.1.2/03
1993 Sunlight Photodegeneration of 14CMCPA in a Buffered Aqueous Solution
at pH 5 by Natural Sunlight
Generated by: PTRL West Inc, USA
Submitted by: MCPA Dossier
Preparation Working Group
Report No: PTRL 410 W-1
GLP: No
unpublished
5
Entries are based on information received from the Notifier(s) and in certain cases Member States. Neither the Commission nor
the Member States are responsible for the completeness or validity of this information received.
- 19 MCPA
APPENDIX IIIA
List of studies
05 April 2005
Annex
point/
reference
number
Author(s)
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA
7.2.1.2
Ghodes
1990 Artificial Sunlight Photodegradation of
14
C-MCPA in Buffered Aqueous
Solutions
Generated by Industry Task Force II
on MCPA Research Data
Submitted by: MCPA Dossier
Preparation Working Group
Report No: HLA 6237-108
GLP: Yes
unpublished
IIA 2.1.4
Kröhl T
1994 Physical and Chemical Properties
Report for MCPA
Generated by: BASF AG
Submitted by: MCPA Dossier
Preparation Working Group
Report No: PCF 01410
GLP: Yes
unpublished
IIA 2.8.1
Lai, I
1993 Hydrolysis of 14C-MCPA Acid in
Buffered Aqueous Solutions
Generated by: Batelle Memorial
Institute
Submitted by: MCPA Dossier Working
Group
Report No: SC 910160
GLP: Yes
unpublished
IIA 2.12.1 Löffler, U
1994 Safety characteristics of the active
ingredient MCPA
Generated by: BASF AG
Submitted by: MCPA Dossier
Preparation Working Group
Report No: BASF 94/10976
GLP: Yes
unpublished
Reports5 on
previous use in
granting
national
authorizations
- 20 MCPA
APPENDIX IIIA
List of studies
05 April 2005
Annex
point/
reference
number
Author(s)
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
II 2.8.4
Redeker D C
1988 Determination of the pKa value in water
Generated by: BASF AG
Submitted by: MCPA Dossier
Preparation Working Group
Report No: 2515
GLP: Yes
unpublished
IIA 2.1.1
Roberts N A
1993 Determination of Physico-Chemical
Properties of MCPA Technical Acid
Generated by: Rhône Poulenc
Chemicals Ltd
Submitted by: MCPA Dossier
Preparation Working Group
Report No: 15
GLP: Yes
unpublished
IIA 2.1.2
Türk W
1994 Determination of the appearance, the
melting point and thermal conversions
of MCPA
Generated by: BASF AG
Submitted by: MCPA Dossier
Preparation Working Group
Report No: PCP 03317
GLP: Yes
unpublished
IIA 2.4.1
Türk W
1994 Spectra of MCPA
Generated by: BASF AG
Submitted by: MCPA Dossier
Preparation Working Group
Report No: BASF 94/11114
GLP: Yes
unpublished
Reports5 on
previous use in
granting
national
authorizations
- 21 MCPA
APPENDIX IIIA
List of studies
05 April 2005
Annex
point/
reference
number
Author(s)
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 4.1.1
Landvoigt
1993 Determination of dioxins and
benzofurans in 2,3-D, 2,4-DCP,
MCPA, 2.4-DP, CMPP and 2,4-DPB
and the isoporpl- and isoocytl-esters of
these acids by GC/MS.
Generated by: Chemserv/TPH
Submitted by: MCPA Dossier
Preparation Working Group
File No: 60288
GLP: Yes
unpublished
IIA 4.2.1
Pfarl C
1994 Validation of an analytical method for
determination of residues of MCPA in
cereals.
Generated by: Agrolinz Mclamin
GmbH
Submitted by: MCPA Dossier
Preparation Working Group
File No: 1172a
GLP: Yes
unpublished
IIA 4.2.4
Reichert, N
1994 Development and validation of a
method for the dtermination of 2, 4-D
MCPA. Dichloroprop-P and MecopropP in air
Submitted by: MCPA Dossier
Preparation Working Group
File No: RCC 439705
GLP: Yes
unpublished
IIA 2.10
Ackroyd C.
2001 Photochemical Oxidative Degradation
of MCPA (SAR Estimation
Generated by: A H MARKS
Submitted by: MCPA Dossier
Preparation Working Group
GLP: Yes
unpublished
Reports5 on
previous use in
granting
national
authorizations
- 22 MCPA
APPENDIX IIIA
List of studies
05 April 2005
Annex
point/
reference
number
Author(s)
Year
IIA 2.2.1
Chakrabarti, A
1985 Vapor Pressure of MCPA and two
MCPA Esters
La Bean, M S
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
MS Generated by: Dow Chemical Co
Submitted by: MCPA Dossier
Preparation Working Group
Report No: ML-AL-85-40005
GLP: No
unpublished
IIA 2.8.2
Concha M
IIA
Shepler K
7.2.1.2/03
1993 Sunlight Photodegeneration of 14CMCPA in a Buffered Aqueous Solution
at pH 5 by Natural Sunlight
Generated by: PTRL West Inc, USA
Submitted by: MCPA Dossier
Preparation Working Group
Report No: PTRL 410 W-1
GLP: No
unpublished
IIA
7.2.1.2
Ghodes
1990 Artificial Sunlight Photodegradation of
14
C-MCPA in Buffered Aqueous
Solutions
Generated by Industry Task Force II
on MCPA Research Data
Submitted by: MCPA Dossier
Preparation Working Group
Report No: HLA 6237-108
GLP: Yes
Unpublished
IIA 2.1.4
Kröhl T
1994 Physical and Chemical Properties
Report for MCPA
Generated by: BASF AG
Submitted by: MCPA Dossier
Preparation Working Group
Report No: PCF 01410
GLP: Yes
unpublished
Reports5 on
previous use in
granting
national
authorizations
- 23 MCPA
APPENDIX IIIA
List of studies
05 April 2005
Annex
point/
reference
number
Author(s)
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 2.8.1
Lai, I
1993 Hydrolysis of 14C-MCPA Acid in
Buffered Aqueous Solutions
Generated by: Batelle Memorial
Institute
Submitted by: MCPA Dossier Working
Group
Report No: SC 910160
GLP: Yes
unpublished
IIA 2.12.1 Löffler, U
1994 Safety characteristics of the active
ingredient MCPA
Generated by: BASF AG
Submitted by: MCPA Dossier
Preparation Working Group
Report No: BASF 94/10976
GLP: Yes
Unpublished
II 2.8.4
Redeker D C
1988 Determination of the pKa value in water
Generated by: BASF AG
Submitted by: MCPA Dossier
Preparation Working Group
Report No: 2515
GLP: Yes
unpublished
IIA 2.1.1
Roberts N A
1993 Determination of Physico-Chemical
Properties of MCPA Technical Acid
Generated by: Rhône Poulenc
Chemicals Ltd
Submitted by: MCPA Dossier
Preparation Working Group
Report No: 15
GLP: Yes
Unpublished
Reports5 on
previous use in
granting
national
authorizations
- 24 MCPA
APPENDIX IIIA
List of studies
05 April 2005
Annex
point/
reference
number
Author(s)
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 2.1.2
Türk W
1994 Determination of the appearance, the
melting point and thermal conversions
of MCPA
Reports5 on
previous use in
granting
national
authorizations
Generated by: BASF AG
Submitted by: MCPA Dossier
Preparation Working Group
Report No: PCP 03317
GLP: Yes
unpublished
IIA 2.4.1
Türk W
1994 Spectra of MCPA
Generated by: BASF AG
Submitted by: MCPA Dossier
Preparation Working Group
Report No: BASF 94/11114
GLP: Yes
Unpublished
B.6 Toxicology and metabolism
Annex
Author(s)
point/
reference
number
Year Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 5.4.1
1993 Chinese hamster ovary/HGPRT locus
assay: MCPA acid
Adams K
Huntingdon Research Centre,
Huntingdon UK, Report No: 93/10949
GLP: unpublished
IIA 5.4.1
Akhurst LC
1993 et al
MCPA acid: Metaphase chromosome
analysis of Human lymphocytes
cultured in vitro.
Huntingdon Research Centre, UK.
Report No: 93/10952
GLP: Yes
unpublished
Reports on
previous use
in granting
national
authorizations
- 25 MCPA
APPENDIX IIIA
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 5.1.1
1992 Acute oral toxicity to rats of MCPA
(a) DMAS.
Allan S A
Generated by: Industry Task Force II
on MCPA Research Data
Submitted by: MCPA Dossier
Preparation Working Group.
Report No: 920499D/JEL 12/AC
GLP: Yes
unpublished
IIA 5.1.2
Allan SA
1992 MCPA DMAS Acute dermal toxicity to
(b) the rabbit.
Generated by: Industry Task Force II
on MCPA Research Data.
Submitted by: MCPA Dossier
Preparation Working Group.
Report No: 920479D/JEL 14/AC
GLP: Yes
unpublished
IIA
5.2.2.1
Baldrick P
1992 et al
Twenty one dermal toxicity study in the
rabbit with MCPA
Huntingdon Research Centre,
Huntingdon, UK
Report No: 92/11896
GLP: Yes
unpublished
IIA 5.1.2
Denton S M
1993 Skin sensitisation to the guinea pig of
MCPA-DMA
Generated by: Industgry Task Force II
on MCPA Research Data
Submitted by: MCPA Dossier
Preparation Working Group.
Report No: JEL 85/930163/SS
GLP
Unpublished
GLP: Yes
unpublished
Reports on
previous use
in granting
national
authorizations
- 26 MCPA
APPENDIX IIIA
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 5.5.1
1992 Preliminary study of the maternal
(a) toxicity of MCPA acid in rats after oral
administration (gavage)
Hellwig J
BASF Aktiengesellschaft,
Ludwigshafen, Germany
Report No: 92/10719
GLP: Yes
unpublished
IIA 5.5.1
Hellwig J
1992 Preliminary study of the material
(b) toxicity nof MCPA acid in rabbits after
oral administration (gavage)
BASF Aktiengesellshcaft,
Ludwigshafen, Germany
Report No: 92/10842
GLP: Yes
unpublished
IIA 5.5.1
Hellwig J et al
Hildebrand B
1993 Study of the prenatal toxicity of MCPA
(a) acid in rats after oral administration
(gavage)
BASF Aktiengesellschaft,
Ludwigshafen, Germany
Report No: 93/10156
GLP: Yes
unpublished
IIA 5.5.1
Hellwig J et al
Hildebrand B
1993 Study of the prenatal toxicity of MCPA
(b) acid in rabbits after oral administration
(gavage)
BASF Aktiengesellschaft,
Ludwigshafen, Germany
Report No: 93/10155
GLP: Yes
unpublished
Reports on
previous use
in granting
national
authorizations
- 27 MCPA
APPENDIX IIIA
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 5.4.1
1993 Ames Salmonella typhimurium
bacterial reverse mutation assay on
MCPA acid.
Jones E et
Huntingdon Research Centre,
Huntingdon, UK
Report No: 93/10945
GLP: Yes
unpublished
IIA 5.1.2
Ligget M P
1992 Skin irritation to the rabbit of MCPA
(a) DMAS.
Generated by: Industry Task Force II
on MCPA Research Data
Submitted by MCPA Dossier
Preparation Working Group
Report No: 920422D/JEL 20/SE
GLP: Yes
unpublished
IIA 5.4.2
Proudlock R T
1993 et al
MCPA acid: Micronucleus test.
Huntingdon Research Centre,
Huntingdon, UK
Report No: 93/10955
GLP: Yes
unpublished
IIA 5.4.1
Adams K
1993 Chinese hamster ovary/HGPRT locus
assay: MCPA acid
Huntingdon Research Centre,
Huntingdon UK, Report No: 93/10949
GLP:unpublished
IIA 5.4.1
Akhurst LC
1993 MCPA acid: Metaphase chromosome
analysis of Human lymphocytes
cultured in vitro.
Huntingdon Research Centre, UK.
Report No: 93/10952
GLP: Yes
Unpublished
Reports on
previous use
in granting
national
authorizations
- 28 MCPA
APPENDIX IIIA
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 5.1.1
1992 Acute oral toxicity to rats of MCPA
(a) DMAS.
Allan S A
Generated by: Industry Task Force II
on MCPA Research Data
Submitted by: MCPA Dossier
Preparation Working Group.
Report No: 920499D/JEL 12/AC
GLP: Yes
unpublished
IIA 5.1.2
Allan S A
1992 MCPA DMAS Acute dermal toxicity to
(b) the rabbit.
Generated by: Industry Task Force II
on MCPA Research Data.
Submitted by: MCPA Dossier
Preparation Working Group.
Report No: 920479D/JEL 14/AC
GLP: Yes
unpublished
IIA
5.2.2.1
Baldrick P
1992 Twenty one dermal toxicity study in the
rabbit with MCPA
Huntingdon Research Centre,
Huntingdon, UK
Report No: 92/11896
GLP: Yes
unpublished
IIA 5.1.2
Denton S M
1993 Skin sensitisation to the guinea pig of
MCPA-DMA
Generated by: Industgry Task Force II
on MCPA Research Data
Submitted by: MCPA Dossier
Preparation Working Group.
Report No: JEL 85/930163/SS
GLP
Unpublished
Reports on
previous use
in granting
national
authorizations
- 29 MCPA
APPENDIX IIIA
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 5.5.1
1992 Preliminary study of the maternal
(a) toxicity of MCPA acid in rats after oral
administration (gavage)
Hellwig J
BASF Aktiengesellschaft,
Ludwigshafen, Germany
Report No: 92/10719
GLP: Yes
unpublished
IIA 5.5.1
Hellwig J
1992 Preliminary study of the material
(b) toxicity nof MCPA acid in rabbits after
oral administration (gavage)
BASF Aktiengesellshcaft,
Ludwigshafen, Germany
Report No: 92/10842
GLP: Yes
unpublished
IIA 5.5.1
Hellwig J et al
Hildebrand B
1993 Study of the prenatal toxicity of MCPA
(a) acid in rats after oral administration
(gavage)
BASF Aktiengesellschaft,
Ludwigshafen, Germany
Report No: 93/10156
GLP: Yes
unpublished
IIA 5.5.1
Hellwig J et al
Hildebrand B
1993 Study of the prenatal toxicity of MCPA
(b) acid in rabbits after oral administration
(gavage)
BASF Aktiengesellschaft,
Ludwigshafen, Germany
Report No: 93/10155
GLP: Yes
unpublished
Reports on
previous use
in granting
national
authorizations
- 30 MCPA
APPENDIX IIIA
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 5.4.1
1993 Ames Salmonella typhimurium
bacterial reverse mutation assay on
MCPA acid.
Jones E
Huntingdon Research Centre,
Huntingdon, UK
Report No: 93/10945
GLP: Yes
unpublished
IIA 5.1.2
Ligget M P
1992 Skin irritation to the rabbit of MCPA
(a) DMAS.
Generated by: Industry Task Force II
on MCPA Research Data
Submitted by MCPA Dossier
Preparation Working Group
Report No: 920422D/JEL 20/SE
GLP: Yes
unpublished
IIA 5.4.2
Proudlock R T
1993 MCPA acid: Micronucleus test.
Huntingdon Research Centre,
Huntingdon, UK
Report No: 93/10955
GLP: Yes
unpublished
Reports on
previous use
in granting
national
authorizations
- 31 MCPA
APPENDIX IIIA
List of studies
05 April 2005
B.7 Residue data
Annex
Author(s)
point/
reference
number
Year
IIA 6.5
1988 MCPA Confined Accumulation Study
on Rotational Crops.
Ewing D D
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Generated by: Industry Task Force I
on MCPA Research Data
Submitted by MCPA Dossier
Preparation Working Group.
Report No: PAL-EF-86-31
GLP: Yes
unpublished
IIA 6.3
Pfarl C
1994 Residues of MCPA in grassland
treated with 2.01 Dicopur M/ha
Generated by: Agrolinz Melamin
GmbH
Submitted by: MCPA Dossier
Preparation Working Group
Report No: 1209
GLP: Yes
unpublished
IIA 6.3
Pfarl C
1994 Residues of MCPA in cereals treated
with 2.01 Dicpur M/ha
Generated by Agrolinz Melamin GmbH
Submitted by: MCPA Dossier
Preparation Working Group
Report No: 1194
GLP: Yes
unpublished
IIA 6.5
Ewing D D
1988 MCPA Confined Accumulation Study
on Rotational Crops.
Generated by: Industry Task Force I
on MCPA Research Data
Submitted by MCPA Dossier
Preparation Working Group.
Report No: PAL-EF-86-31
GLP: Yes
unpublished
Reports on
previous use
in granting
national
authorizations
- 32 MCPA
APPENDIX IIIA
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 6.3
1994 Residues of MCPA in grassland
treated with 2.01 Dicopur M/ha
Pfarl C
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Reports on
previous use
in granting
national
authorizations
Generated by: Agrolinz Melamin
GmbH
Submitted by: MCPA Dossier
Preparation Working Group
Report No: 1209
GLP: Yes
unpublished
IIA 6.3
Pfarl C
1994 Residues of MCPA in cereals treated
with 2.01 Dicpur M/ha
Generated by Agrolinz Melamin GmbH
Submitted by: MCPA Dossier
Preparation Working Group
Report No: 1194
GLP: Yes
unpublished
B.8 Environmental fate and behaviour
Annex
Author(s)
point/
reference
number
Year
IIA 7.1.1
1994 Photodegradation of (14C) MCPA in/on
Soil by Natural Sunlight
Concha M
Shepler K
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Generated by: Industry Task Force II
on MCPA Research Data
Submitted by: MCPA Dossier
Preparation Working Group
Report No: 436W-1
GLP: Yes
unpublished
Reports on
previous use
in granting
national
authorizations
- 33 MCPA
APPENDIX IIIA
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 7.2.1
1993 Sunlight Photodegradation of (14C)
MCPA in a Buffered Aqueous Solution
at pH 5 by Natural Sunlight.
Concha M
Shepler B S
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Generated by: Industry Task Force II n
MCPA Research Data
Submitted by: MCPA Dossier
Preparation Working Group
Report No: 410W-1
GLP: Yes
upublished
II 7.1.2
Fernando T R
1992 Sorption/Desorption of 14C-MCPA Acid
on Soils by the Batch Equilibrium
Method.
Generated by: Industry Task Force II
on 5260
MCPA Research Data
Submitted by: MCPA Dossier
Preparation Working Group
Report No: SC910081
GLP: Yes
unpublished
IIA 7.1.2
Godwin P A
Laskowski D A
1988 An Adsorption Study of MCPA
Generated by: Industry Task Force I
on MCPA Research Data
Submitted by: MCPA Dossier
Preparation Working Group
Report No: GH-C 1995
GLP: Yes
unpublished
IIA 7.2.1
Lai I
1993 Hydrolysis of 14C-MCPA acid in
buffered aqueous solutions
Report No: SC910160
GLP: Yes
unpublished
Reports on
previous use
in granting
national
authorizations
- 34 MCPA
APPENDIX IIIA
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 7.1.1
1990 Aerobic and Aerobic/Anaerobic Soil
Metabolsim of 14C-MCPA
Matt F J
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Generated by: Industry Task Force II
on MCPA Research Data
Submitted by: MCPA Dossier
Preparation Working Group
Report No: HLA 6237-107
GLP: Yes
unpublished
IIA 7.2.1
Obrist J J
1987 Anaerobic Aquatic Metabolism of
(b) MCPA
Generated by: Industry Task Force I
on MCPA Research Data
Submitted by: MCPA Dossier
Preparation Working Group.
Report No: HLA 6015-325
GLP: Yes
unpublished
IIA 7.1.2
Tudor R.F
1992 Sorption/Desorption of 14C-MCPA acid
on Soils by the Batch Equilibrium
Method
Generated by: Industry Task Force II
on MCPA Research Data
Submitted by: MCPA Dossier
Preparation Working Group
Report No: SC910081
GLP: Yes
unpublished
IIA
Concha M
7.1.1.1.3/ Shepler K
02
1994 Photodegradation of (14C) MCPA in/on
Soil by Natural Sunlight
Generated by: Industry Task Force II
on MCPA Research Data
Submitted by: MCPA Dossier
Preparation Working Group
Report No: 436W-1
GLP: Yes
Unpublished
Reports on
previous use
in granting
national
authorizations
- 35 MCPA
APPENDIX IIIA
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA
Concha M
7.2.1.21/0 Shepler B S
3
1993 Sunlight Photodegradation of (14C)
MCPA in a Buffered Aqueous Solution
at pH 5 by Natural Sunlight.
Generated by: Industry Task Force II n
MCPA Research Data
Submitted
by:
MCPA
Preparation Working Group
Dossier
Report No: 410W-1
GLP: Yes
unpublished
IIA
7.1.2/01
Fernando T R
1992 Sorption/Desorption of 14C-MCPA Acid
on Soils by the Batch Equilibrium
Method.
Generated by: Industry Task Force II
on 5260
MCPA Research Data
Submitted by: MCPA Dossier
Preparation Working Group
Report No: SC910081
GLP: Yes
unpublished
IIA
7.1.2/02
Godwin P A
Laskowski D A
1988 An Adsorption Study of MCPA
Generated by: Industry Task Force I
on MCPA Research Data
Submitted by: MCPA Dossier
Preparation Working Group
Report No: GH-C 1995
GLP: Yes
Unpublished
IIA
Lai I
7.2.1.1/01
1993 Hydrolysis of 14C-MCPA acid in
buffered aqueous solutions
Report No: SC910160
GLP: Yes
unpublished
Reports on
previous use
in granting
national
authorizations
- 36 MCPA
APPENDIX IIIA
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA
7.1.1.1.1
1990 Aerobic and Aerobic/Anaerobic Soil
Metabolsim of 14C-MCPA
Matt F J
IIA
7.1.1.1.2
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Generated by: Industry Task Force II
on MCPA Research Data
Submitted by: MCPA Dossier
Preparation Working Group
Report No: HLA 6237-107
GLP: Yes
unpublished
IIA
Orbist J J
7.2.1.4/01
1987 Anaerobic Aquatic Metabolsim of
(b) MCPA
Generated by: Industry Task Force I
on MCPA Research Data
Submitted by: MCPA Dossier
Preparation Working Group.
Report No: HLA 6015-325
GLP: Yes
unpublished
IIA
Tudor R.F
7.2.1.3.2/
01
1992 Sorption/Desorption of 14C-MCPA acid
on Soils by the Batch Equilibrium
Method
Generated by: Industry Task Force II
on MCPA Research Data
Submitted by: MCPA Dossier
Preparation Working Group
Report No: SC910081
GLP: Yes
unpublished
Reports on
previous use
in granting
national
authorizations
- 37 MCPA
APPENDIX IIIA
List of studies
05 April 2005
B.9 Ecotoxicology
Annex
Author(s)
point/
reference
number
Year
IIA 8.2.1
1990 MCPA (as DMA-salt):96 hour acute
(a) toxicity study (LC50) in the rainbow
trout (flow through).
Bogers M
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Industry Task Force II on MCPA
Report No: 019585
GLP: Yes
unpublished
IIA 8.2.1
Bogers M
1990 MCPA (as DMA-salt):96 hour acute
(b) toxicity study (LC50) in the carp (static)
Industry Task Force II on MCPA
Research Data.
Report No: 018191
GLP: Yes
unpublished
IIA 8.1.2
Grimes J
Jaber M
1987 MCPA Dimethylamine salt (2-methyl-4
chloro-phenoxyacetic acid
dimethylamine salt) - a dietary LC50
study with the Bobwhite.
Industry Task Force I on MCPA
Research Data
Report No: 103-284
GLP: Yes
unpublished
IIA 8.1.1
Grimes J
Jaber M
1986 MCPA DMA: An Acute Oral Toxicity
(a) Study with the Bobwhite.
Industry Task Force I on MCPA
Research Data
Report No: 222-101
GLP: Yes
unpublished
IIA 8.1.1
Grimes J
Jaber M
1986 MCPA Acid: An Acute Oral Toxicity
(b) Study with the Bobwhite.
Industry Task Force I on MCPA
Research Data.
Report No: 222-102
GLP: Yes
unpublished
Reports on
previous use
in granting
national
authorizations
- 38 MCPA
APPENDIX IIIA
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA
8.3.1.1
1991 An Acute contact Toxicity Study with
the Honey Bee MCPA DMAS
Hoxter K A
Lynn S P
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Industry Task Force II on MCPA
Research Data
Report No: 222-102
GLP: Yes
unpublished
IIA 8.2.6
Müllershön H
1990 Influence of MCPA (as DMA salt) on
the reproduction of Daphnia magna
Industry Task Force II on MCPA
Research Data
Report No: 167804
GLP: Yes
unpublished
IIA 8.2.2
Munk R
1990 Sublethal toxic effects of MCPADimethylamine salt on rainbow trout
(Salmo gairdneri RICH =
Oncorhynchus mykiss) in a flow
through system (28 days)
Industry Task Force II on MCPA
Research Data
Report No: 42F0878/895259
GLP: Yes
unpublished
IIA 8.2.5
Putt A E
1992 MCPA DMAS - Acute toxicity to
Daphnids (Daphnia magna) under
flow-through conditions.
Industry Task Force II on MCPA
Research Data
Report No: 92-4-4235
GLP: Yes
unpublished
Reports on
previous use
in granting
national
authorizations
- 39 MCPA
APPENDIX IIIA
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 8.2.1
1986 Static Acute Toxicity of Technical
(a) MCPA Dimethylamine salt (2-methyl-4chloro-phenoxyacetic acid,
dimethylamine salt) to the rainbow
trout Salmo gairdneri.
Ward T J
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Industry Task Force I on MCPA
Research Data
Report No: D1386
GLP: Yes
unpublished
IIA 8.2.1
Ward T J
1986 Static Acute Toxicity of Technical
(b) MCPA Dimethylamine salt (2-methyl-4chloro-phenoxyacetic acid,
dimethylamine salt) to the Bluegill,
Lepomis macrochirus.
Industry Task Force I on MCPA
Research Data.
Report No: D1186
GLP: Yes
unpublished
Reports on
previous use
in granting
national
authorizations
- 40 MCPA-THIOETHYL
APPENDIX IIIA
List of studies
05 April 2005
APPENDIX IIIA
MCPA-THIOETHYL
List of studies for which the main submitter has claimed data protection
and which during the re-evaluation process were considered as essential
for the evaluation with a view to Annex I inclusion.
B.1 Identity, B.2 Physical and chemical properties, B.3 Data on application and further
information, B.4 Proposals for classification and labelling, B.5 Methods of analysis
Annex
Author(s)
point/
reference
number
IIA 2.1.1, Anonimous
2.1.2, 2.2,
2.4, 2.5.1,
2.5.2, 2.6,
2.7, 2.8.1,
2.9.1,
2.9.2
IIA 2.14
P. D’Olimpio
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Physical and chemical properties of Phenothiol
not
report HOKKO Chem. Ind.
ed
GLP: No
unpublished
2000
IIA 2.3.1, I. Flack
2.3.2,
2.5.1,
2.10,
2.11.1,
2.13, 2.15
1996
IIA 2.1,
2.4, 2.9.4
1998
H Honda
Surface tension of Phenothiol T.G.
Centro Ricerche Novara “Istituto Guido Donegani”
(ENICHEM SpA)
001/00
GLP: Yes
unpublished
Phenothiol: physical and chemical properties
Huntingdon Life Sciences Ltd
OXN 181/961980
GLP: Yes
unpublished
Determination of physical-chemical properties of MCPA
–thioethyl
Mistsubishi Chemical Safety Institute
BF031G-BF036G
GLP: Yes
unpublished
- 41 MCPA-THIOETHYL
APPENDIX IIIA
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 2.5.1
1999
S. Maki (a)
IIA 2.9.1
S. Maki (b)
1999
IIA 2.3.1
E. Nagayoshi (a)
1999
IIA 2.6
E. Nagayoshi (b)
1999
IIA 2.7
E. Nagayoshi (c)
1999
IIA 2.8
E. Nagayoshi (d)
1999
IIA 2.9.2
Y. Shimamura
1999
IIA 2.9.3
H. Werle
1992
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Infrared, Ultraviolet/Visible, Mas and Nuclera Magnetic
Resonance spectra of MCPA-thioethyl
Institute Envir. Toxicology
IET 98-5010-1
GLP: Yes
unpublished
Hydrolysis rate of MCPA-thyoethyl
Institute Envir. Toxicology
IET 98-5010-7
GLP: Yes
unpublished
Vapour pressure of MCPA-thioethyl
Institute Envir. Toxicology
IET 98-5010-2
GLP: Yes
unpublished
Water solubility of MCPA-thioethyl
Institute Envir. Toxicology
IET 98-5010-3
GLP: Yes
unpublished
Solubility of MCPA-thioethyl in organic solvents
Institute Envir. Toxicology
IET 98-5010-4
GLP: Yes
unpublished
Solubility of MCPA-thioethyl in organic solvents
Institute Envir. Toxicology
IET 98-5010-6
GLP: Yes
unpublished
Photolysis rate of MCPA-thioethyl in water
Institute Envir. Toxicology
IET 98-5010-8
GLP: Yes
unpublished
Photolysis study (Quantum Yield) of Phenothiol in
water
Biochem GmbH
915040574B
GLP: Yes
unpublished
- 42 MCPA-THIOETHYL
Annex
Author(s)
point/
reference
number
IIA 4.1
IIA 4.2.1
IIA 4.2.1
IIA 4.1
IIA 4.2.1
IIA 4.2.1
IIA 4.2.1
IIA 4.2.1
APPENDIX IIIA
List of studies
05 April 2005
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Method for the gas-chromatographic determination of
Anonimous
Not
report MCPA thioethyl
HOKKO Chem. Ind.
ed
GLP: No
unpublished
Anonimous
1989 Method for the gas-chromatographic determination of
MCPA thioethyl in hulled rice
HOKKO Chem. Ind
GLP: No
unpublished
C. Fraschini
1998 Analysis of Phenothiol residues on tomato (whole fruit)
SIPCAM S.p.A
SIP1108
GLP: Yes
unpublished
S. Garofani
2000 Phenothiol technical: determination of the A.I. content
validation of the analytical method
ChemService S.r.l.
CH-48/2000
GLP: Yes
unpublished
M. Mazzocchi (a) 2000 Method validation (SIP 1238) for the determination of
Phenothiol Herbicide residues in tomato samples
Larpest SrL
SIP 02/00
GLP: Yes
unpublished
M. Mazzocchi (b) 2000 Method validation (SIP 1240) for the determination of
Phenothiol Herbicide residues in strawberry samples
Larpest SrL
SIP 03/00
GLP: Yes
unpublished
M. Mazzocchi (c) 2000 Method validation (SIP 1239) for the determination of
Phenothiol Herbicide residues in orange samples
Larpest SrL
SIP 04/00
GLP: Yes
unpublished
C. Sasso (a)
2000 Validation of method for residue analysis of Phenothiol
in tomato samples
SIPCAM SpA
SIP 1238
GLP: Yes
unpublished
- 43 MCPA-THIOETHYL
APPENDIX IIIA
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 4.2.1
C. Sasso (b)
2000
IIA 4.2.1
C. Sasso (c)
2000
IIA 4.2.2
C. Sasso (d)
2000
IIA 4.2.3
C. Sasso (e)
2000
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Validation of method for residue analysis of Phenothiol
in citrus fruit samples
SIPCAM SpA
SIP 1239
GLP: Yes
unpublished
Validation of method for residue analysis of Phenothiol
in strawberry samples
SIPCAM SpA
SIP 1240
GLP: Yes
unpublished
Validation of method for residue analysis of Phenothiol
in soil
SIPCAM SpA
SIP 1242
GLP: Yes
unpublished
Validation of method for residue analysis of Phenothiol
in surface water
SIPCAM SpA
SIP 1241
GLP: Yes
unpublished
B.6 Toxicology and metabolism
Annex
Author(s)
point/
reference
number
IIA 5.3.1
Anonimous
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
1973 Phenothiol: oral subacute toxicity study in the mouse
for 7 months
Japan Bio-test Laboratories Inc.
Japan Veterinary Zootechny College,
HOKKO Chem. Ind
GLP: No
IIA5.1.3
S.V.Church
unpublished
1984 Acute inhalation toxicity evaluation in rats
International Research & Development Corporation
515-001
GLP: Yes
unpublished
- 44 MCPA-THIOETHYL
Annex
Author(s)
point/
reference
number
IIA 5.1.1
S.Dickhaus (a)
APPENDIX IIIA
List of studies
05 April 2005
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
1991 Acute oral toxicological study of compound Phenothiol
(tcn.act.agent) after one oral application to the rat
Pharmatox GmbH
1-4-11-91
GLP: Yes
IIA 5.1.1
S.Dickhaus (b)
unpublished
1991 Acute oral toxicological study of compound Phenothiol
(tcn.act.agent) after one oral application to the mouse
1-1-12-91
Pharmatox GmbH
GLP: Yes
IIA 5.1.2
S.Dickhaus (c)
unpublished
1991 Acute toxicological study on compound Phenothiol
(tcn.act.agent) after dermal application to the rat
Pharmatox GmbH
1-4-13-91
GLP: Yes
IIA 5.1.5
S.Dickhaus (d)
unpublished
1991 Irritant effects of Phenothiol (tcn.act.agent) on rabbit
skin acc. to Draize
Pharmatox GmbH
1-3-14-91
GLP: Yes
IIA 5.1.5
S.Dickhaus (e)
unpublished
1991 Irritant effects of Phenothiol (tcn.act.agent) on rabbit
eye
Pharmatox GmbH
1-3-15-91
GLP: Yes
IIA 5.3.1
T.Harada
unpublished
1992 Phenothiol: 18 months oral oncogenicity study in mice
Institute of Environmental Toxicology-Kodaira
IET 89-0077
GLP: Yes
IIA 5.1.1
R. Itoh, S. Toida
unpublished
1974 Acute oral toxicity of Phenothiol
Department of Pharmacology, Faculty of Medicine
Toho university
GLP: No
unpublished
- 45 MCPA-THIOETHYL
Annex
Author(s)
point/
reference
number
IIA 5.1.2
S. Kobayashi (a)
APPENDIX IIIA
List of studies
05 April 2005
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
1983 Report on the acute dermal toxicity with Phenothiol in
rats
HOKKO Chem. Ind.
GLP:No
IIA 5.1.5
S.Kobayashi (b)
unpublished
1982 Skin and eye irritation studies with Phenothiol in
rabbits
HOKKO Chem. Ind.
GLP: No
IIA
5.3.1
K.Maita
unpublished
1988 Phenothiol: 24-months oral chronic toxicity and
oncogenicity study in rats
Institute of Environmental Toxicology
Research Institute for Animal Science in Biochemistry
and Toxicology
GLP: Yes
IIA 5.3
K.Mastalski
unpublished
1976 Two-year chronic oral toxicity study with Phenothiol in
beagle dogs
Industrial Bio-Test Laboratories Inc.
651-05288
GLP: Yes
IIA 5.5.2
M.K.Morgan
unpublished
1976 Three-generation reproduction study with Phenothiol in
albino
Industrial Bio-test Laboratories Inc.
623-05289
GLP: No
IIA 5.2.2
L.Morrow (a)
unpublished
1974 90-day subacute oral toxicity study with Phenothiol in
albino rats
Industrial Bio-test Laboratory Inc
621-03772
GLP: No
IIA 5.2.2
L.Morrow (b)
unpublished
1974 90-day subacute oral toxicity study with Phenothiol in
albino mice
Industrial Bio-test Laboratory Inc
621-03773
GLP: No
unpublished
- 46 MCPA-THIOETHYL
Annex
Author(s)
point/
reference
number
IIA 5.6.1
H.Ohyama
APPENDIX IIIA
List of studies
05 April 2005
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
1977 Metabolism and degradation of Phenothiol
Agricultural department Nagoya University HOKKO
Chem. Ind
GLP: No
IIA 5.5.1
S. Sakamaki, M.
terazu, N. Kurita,
Y Abo, Y.Sugiya
unpublished
1985 Report on the teratology study in rabbits treated orally
with Phenothiol
Medical Scientific Research laboratory
HO-541
GLP: Yes
IIA 5.4.1
T.Shibuya
unpublished
1984 Chromosome test of Phenothiol in Chinese Hamster
V79 cells
Hatano Res.Institute, Food and Drug Saf. Center
G-84-01CH
GLP: Yes
IIA 5.4.1
Y.Shirasu, N.
Noriya, K. Kato
unpublished
not Mutagenicity testing on Phenothiol in microbial
report systems
ed Toxicology division, Institute Environmental Toxicology
GLP: No
IIA 5.2.2
M.Skirakawa
unpublished
1973 Phenothiol: subchronic toxicity study in the mouse and
rat for 3 months
Wakayama Medical College
GLP:No
IIA 5.1.6
Y.Sugiya
unpublished
1985 Dermal sensitization study with phenothiol technical in
guinea pig
Medical Scientific Research Laboratory Co, Ltd
HO-5K01
GLP: Yes
IIA 5.5.1
K.Tauchi
unpublished
1984 Teratogenicity study of Phenothiol in the rat
Imamichi Institute for Animal Reproduction
Institute of Environmental Toxicology
147
GLP: Yes
unpublished
- 47 MCPA-THIOETHYL
APPENDIX IIIA
List of studies
05 April 2005
B.7 Residue data
Annex
Author(s)
point/
reference
number
Year
IIA 6.3
1991
Anonimous (a)
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Resultados de los analisis realizados en las meustras
de citricos entregadas por INAGRA
report
Departemento de Biotecnologia- Universidad
politecnica de Valencia
R 9158/1-4
GLP:No
IIA 6.3
Anonymous (b)
1991
unpublished
Results of field residues trials in strawberries
MICROAL Tecnicos en Agroalimentacion Report
R9192/1
GLP: No
IIA 6.3
C. Fraschini
1998
unpublished
Analysis of Phenothiol residues on tomato (whole fruit)
SIPCAM S.p.A.
SIP1108
GLP: Yes
IIA 6.1
H.Ohyama
1977
unpublished
Metabolism and degradation of Phenothiol
Agricultural Department Nagoya University
HOKKO Chem. Ind.
GLP:No
unpublished
B.8 Environmental fate and behaviour
Annex
Author(s)
point/
reference
number
IIA 7.1.1
H.Ohyama
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
1977 Metabolism and degradation of MCPA-Thioethyl
Agricultural Department Nagoya University
HOKKO Chem. Ind
GLP:No
unpublished
- 48 MCPA-THIOETHYL
APPENDIX IIIA
List of studies
05 April 2005
B.9 Ecotoxicology
Annex
Author(s)
point/
reference
number
Year
IIA 8.2.1
1989
Anonimous (a)
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
A report on the toxicity study of Phenothiol to rainbow
trout
HOKKO Chem. Ind.
GLP:No
IIA 8.2.4
Anonimous (b)
1991
unpublished
A report on the toxicity study of Phenothiol to water
flea
HOKKO Chem Ind.
GLP:No
IIA 8.1.1
T.M.M.Coenen
1991
unpublished
Acute oral toxicity study in pigeon with Phenothiol (limit
test)
RCC-Notox
054056
GLP: Yes
IIA 8.2.1
B.Grunert (a)
1991
unpublished
Acute toxicity fish test (OECD guideline 203)Phenothiol
Biochem GmbH
91 20 43 023D
GLP: Yes
IIA 8.2.2
B.Grunert (b)
1991
unpublished
Prolonged toxicity fish test (OECD guideline 204) 21day study-Phenothiol
Biochem GmbH
91 20 43 023C
GLP: Yes
IIA 8.2.5
B.Grunert (c)
1991
unpublished
Daphnia reproduction test- Phenothiol
Biochem GmbH
91 20 43 023B
GLP: Yes
IIA 8.2.6
B.Grunert (d)
1991
unpublished
Alga, growth inhibition test (OECD guideline 201)Phenothiol
91 20 43 023A
Biochem GmbH.
GLP: Yes
unpublished
- 49 MCPA-THIOETHYL
APPENDIX IIIA
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 8.1.1
1977
S.Kobayashi,
S.Tanaka (a)
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Acute oral toxicity of Phenothiol in quails
HOKKO Chem. Ind
GLP:No
IIA 8.2.1
S.Kobayashi,
K.Kawaguchi (b)
1970
unpublished
Toxicity of Phenothiol to carp
HOKKO Chem. Ind.
GLP:No
IIA 8.3.1
S.Moriyama
1981
unpublished
The acute contact toxicity to worker honey bees
HOKKO Chem. Ind.
GLP:No
IIA 8.3.1
J.A. Wiles
1996
published
Phenothiol technical: acute toxicity to honey bees (Apis
mellifera)
Huntingdon Life Sciences Ltd
OXN 182/962866
GLP: Yes
unpublished
- 50 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
APPENDIX IIIB
MCPA
List of studies which were submitted during the evaluation process and
were not cited in the draft assessment report:
B.1 Identity, B.2 Physical and chemical properties, B.3 Data on application and further
information, B.4 Proposals for classification and labelling, B.5 Methods of analysis
Annex
Author(s)
point/
reference
number
Year
IIA 2.7
1987 2-Methyl-4-Chlorophenoxy acetic acid:
Bailey, R E
Hopkings D L
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Determination of Octanol/Water Partition Coefficient
Generated by: Dow Chemical Company
Submitted by: MCPA Dossier Preparation Working
Group
Report No: ES-DR-0004-9672-4
GLP: No
unpublished
IIA 2.2.2
Downley J R
1987 Henry’s Law Constant for 2-methyl-4-Chlorophenoxyacetic Acid in Water
Generated by: Dow Chemical Co
Submitted by: MCPA Dossier Preparation Working
Group
Report No: ML-AL-87-40526
GLP: No
unpublished
IIA 2.5
Hopkins D L
1987 2-Methyl-4-Chlorophenoxy acetic acid
Determination of the Water Solubility
Generated by: Dow Chemical Co
Submitted by: MCPA Dossier Preparation Working
Group
Report No: ES-DR-0004-9672-3
GLP: No
unpublished
- 51 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA
7.2.1.2
1991 Determination of the Phototransformation in water of
MCPA according to UBA Test Guideline Direct
Klöpffer W
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Phototransformation
Generated by: Batelle Europe
Submitted by: MCPA Dossier Preparation
Working Group
Report No: BE-P-118-91-PHO-02
GLP: Yes
Unpublished
IIA 3.1 to
3.5
Kirkwood R C
1983 The relationship of metabolism studies to
the modes of action of herbicides.
Pesticide Science 14: 453-460
GLP: No
published
IIA 3.6
Coupland D
1994 Resistance to the Auxin analog herbicides.
Powles SB & Holtum JAM (Eds): Herbicide resistance
in Plants - Biology and biochemistry.
Lewis Publ.
GLP: No
published
B.6 Toxicology and metabolism
Annex
Author(s)
point/
reference
number
Year
IIA 5.8.2
1983 Enhancement of extrahapatic drug metabolism by
phenoxyacid herbicides and clofibrate.
Ahotupa M
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Extrahepatic Drug Metabol. Chem.
Carcinogenesis (Rydsrom J et al eds).
Elsevier Sci. Publishers B V
Report No: Not given
GLP: Yes
published
- 52 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 5.9.3
1983 Simultaneous determination of active ingredient and
chlorophenol impurities in phenoxy acid herbicide
formulation by high-performance liquid
chromatography with ultra-vilot and electrochemical
detection.
Äkerblom M
Lindgren B
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
J.
Chromatography.
Report No: 83/10368
GLP: No
Published
IIA 5.4.1
Arias E
1992 Sister chromatid exchanges in chick embryos after
treatment with the phenoxy herbicide MCPA
Environ Molecular Mutagen 19.
Report No: 92/1291
GLP: Yes
published
IIA 5.8.2
Bacher M A
Gibson G G
1988 Chlorophenoxyacid herbicides induce microsomal
cytochrome P-450 IVAI (P-452) in rat liver.
Chem Biol. Interactions 65.
Report No: 88/10856
GLP: No
published
IIA 5.9.1
Becher H
1992 A cohort study on persons exposed to phenoxy acid
herbicides and their contaminants in Germany - Design
and first results
Chemosphere 25.
Report No: 92/12297
No GLP
Published
IIA 5.9.2
Bond G G
Rossbacher R
1993 A review of potential human carcinogenicity of the
chlorophenoxy herbicides MCPA, MCPP and 2,4-DP
Dr J Ind. Med, 50
Report No: 93/11582
GLP: No
published
- 53 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 5.9.2
1989 Phenoxy herbicides and caner: Insufficient
epidemiologica evidence for a casual relationship
Bond G G
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Fund. Appl. Toxicol.
Report No: 89/10809
GLP: No
published
IIA 5.1.1
Bräunlich H
1989 Renal handling of 2-methyl-4-chlorophenoxyacetic acid
(MCPA) in rats
J Appl Toxicol 9
Report No: 89/10669
GLP: No
published
IIA 5.4.1
Buselmaier W
1972 Mutagenitäts-Untersuchungen mit Pestizen im Hostmediated assay und mit dem Dominanten Letaltest an
der Maus
Biol Zbl. 91
GLP: No
published
IIA 5.2.4
Christopher D H
Ligget M P
1992 Skin irritation to the rabbit of MCPA acid.
Huntingdon Research Centre, Huntingdon, UK
Report No: 92/11884
GLP: Yes
unpublished
IIA 5.1.3
Clark, G C
Coombs D W
1977 U 46 M-Fluid Acute inhalation toxicity in rats, single 4
hour exposure
Generated by: TPH
Submitted by: MCPA Dossier Preparation Working
Group.
Report No: BSF259/77138
GLP: No
unpublished
IIA 5.9.2
Coggon D
1986 Mortality of workers exposed to 2-methyl-4chlorophenoxyacetic acid
Scand. J Work Environ. Health
Report No: 86/10725
GLP: No
published
- 54 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 5.9.3
1988 Levels of 4-chloro-2-methylphenoxyacetic acid (MCPA)
in the urine of northern Italy occupationally exposed
agricultural workers
De Filip E
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Ecotoxicol. Environ. Safety
Report No 88/10759
GLP: No
published
IIA 5.4.1
Elo HA etal
1991 Inhibition of human and rabbit platelet aggregation by
chlorophenoxyacid herbicides.
Arch toxicol 65.Report No 91/11683
GLP: No
published
IIA 5.4.1
Elo HA etal
1988 Comparative study on cerebrovascular injuries by
three chlorophenoxyacetic acids (2,4,-D, 2,4,5-T and
MCPA)
Comp. Biochem Physiol 90C
Report No: 88/10853
GLP: No
published
IIA 5.4.1
Elo HA etal
1983 Blood-brain barrier damage by three
chlorophenoxyacetic acid herbidices (MCPA, 2,4-D,
2,4,5-T)
Symp Toxicol. Jyväskylä.
Report No: 83/10427
GLP: No
Published
IIA 5.4.1
Elo HA etal
1982 Increase in the penetration of tracer compounds into
the rat brain during 2-methyl-4-chlorophenoxyacetic
acid (MCPA) intoxiaction
Acta Pharmacol/Toxicol
Report No: 82/10233
GLP: No
published
- 55 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 5.8.2
1979 Distribution of 2-methyl-4-chlorophenoxyacetic acid
and 2,4-dichlorophenoxyacetic acid in male rats.
Evidence for the involvement of the central nervous
sytem in their toxicity.
Elo H A
Ylitalo P
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Toxicol Appl. Pharmacol 51.
Report No: 79/10306
GLP: No
Published
IIA 5.4.2
Engelhardt G
Gelbke H P
1986 Cytogenetic investigation in Chinese hamsters after
single oral administration f MCPA (Bone marrow
chromosome analysis), 2nd study.
BASF Aktiengesellschcaft,
Ludwigshafen, Germany
Report No: 86/028
GLP: Yes
unpublished
IIA 5.4.2
Engelhardt G
Gelbke H P
1985 Cytogenetic investigation in Chinese hamsters after
(a) single oral admnistration of MCPA (Bone marrow
chromosome analysis)
BASF Aktiengesellschaft,
Ludwigshafen, Germany
Report No: 85/089
GLP: Yes
Unpublished
IIA 5.4.2
Engelhardt G
Gelbke H P
1985 Cytogenetic investigation in Chinese hamsters after
(b) single oral administration of MCPA (Sister Chromatid
Exchange (SEC),
BASF Aktiengesellschaft, Ludwigshafen Germany
Report No: 85/090
GLP: Yes
unpublished
IIA 5.4.2
Engelhardt G
Gelbke H P
1985 Cytogenetic investigation in Chinese hamsters after
( c) single oral administration of MCPA (Sister Chromatid
Exchange (SCE), Supplementary study
BASF Aktiengesellshcaft, Ludwigshafen, Germany
Report No: 85/091
GLP: Yes
unpublished
- 56 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 5.4.1
1988 2,4-dichlorophenol and MCPA in a V79 test
Fiskesjö
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Scand. Cell Toxicol,Congress 10 ATLA
Report No: 88/10540
GLP: No
published
IIA 5.3.1
Fjeldstat P
Wannag A
1977 Human urinary excretion of the herbicide 2-methyl-4cholorophenoxyacetic acid
Scand J Work Environ. Health 3
Report No: 77/10299
GLP: No
published
IIA 5.9.4
Flanagan R J et
a
1990 Alkaline diurses for acute poisoning with
chlorophenoxy herbicides and ioxynil
The Lancet 335
Report No: 90/10922
GLP: No
published
IIA 5.9.2
Geldermacher
Mallinckrodt M
Lautenback L
1966 Zwei tödliche Vergiftungen (Suicid) mit chlorieten
Phenoxyessigsäuren (2,3-D und MCPA)
Arch Toxicol 21
Report No: 66/10020
GLP: No
published
IIA 5.6
Gilbert C M
Hopkins R
1978 The metabolic fate of [14C]-MCPA (4-chloro-2-methyl
(Ring-U-14C)phenoxyacetic acid)
Hazleton Laboratories Europe Ltd, Harrogate, UK
Report No: 78/0156
GLP: No
unpublished
IIA 5.1.6
Grundler O
Kirsch P
1984 Report on the sensitising effect of MCPA in the Guinea
pig Open Epicutaneous Test (OET)
BASF Aktiengesellschaft, Ludwigshafen, Germany
Report No: 84/237
GLP: Yes
unpublished
- 57 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 5.1.5
1983 Report on the study of the irritation to the eye of the
white rabbit based on Draize
Grundler O J
Kirsch P
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Generated by TPH:
Submitted by: MCPA Dossier Preparation Working
Group.
Report No: 83/192
GLP: No
unpublished
IIA 5.3
Gurd M R et al
1965 Summary of toxicological data: Acute toxicity and 7month feeding studies with Mecoprop and MCPA
Fd. Cosmet. Toxicol.
Report No 65/10017
GLP: No
published
IIA 5.1.3
Hardy C J
Jackson G C
Molloy G K
1983 Acute inhalation toxicity to rats of MCPA DMAS
Generated by: Industry Task Force II on MCPA
Research Data
Submitted by: MCPA Dossier Preparation Working
Group
Report No: JEL 16/921581
GLP: Yes
unpublished
IIA 5.8.1
Hattula M L et al
1977 Acute and subchronic toxicity of 2-methyl-4-chlorophenoxyacetic acid (MCPA) in male rat. I. Light
micriscopy and tissue concentrations of MCPA
Bull Environ. Contam Toxicol
Report No: 83/10259
GLP: No
published
IIA 5.8.1
Hayes W J
Laws E R (eds)
1991 Handbook of pesticide toxicology
Academic Pres. San Diego
Report No: 79/10376
GLP: No
published
- 58 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 5.3
1986 Report on the study of the toxicity of MCPA in Beagle
dogs after 12-month administration in the diet
Hellwig J et al
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
BASF Aktiengesellschaft, Ludwigshafen Germany.
Report No: 86/285
GLP: Yes
unpublished
IIA 5.7
Hervonen H et al 1982 Blood-brain barrier damage by 2-methyl-4chlorophenoxyacetic acid herbicide in rats
Toxicol Appl. Pharmacol 65
Report No: 82/10232
GLP: No
published
IIA 5.8.2
Hietanen E et al
1985 Enhanced peroxisomal ß-oxidation of fatty acids and
glutathione metabolism in rats exposed to
phenoxyacetic acids.
Toxicology
Report No:85/10492
GLP: No
unpublished
IIA 5.8.2
Hietanen E et al
1983 Effects of phenoxy herbicides and glyphosate on the
hepatic and intestinal biotransformation activities in the
rat.
Acta Pharmacol Toxicol.
Report No: 10512
GLP: No
published
IIA 5.8.2
Inomata N et al
1991 Effects of ethyl 4-chloro-2-methylphenoxyacetic on
(a) hepatic peroxisomal enzymes in rats
Tohoku J Exp Med
Report No: 91/11682
GLP: No
published
IIA 5.8.2
Inomata N et al
1991 Effects of MCPA and other phenoxyacid compounds
(b) on hepatic xenophobic metabolsim in rats
Tohoku J Exp Med
Report No: 91/11681
GLP: No
published
- 59 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 5.5.1
1980 MCPA oral teratogenicity in the rat
Irvine L F H
(a)
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Hazleton Laboratories Europe, Harrogate, UK
Report No: 80/0136
GLP: No
upublished
IIA 5.5.1
Irvine L F H
Tucker M L
1980 MCPA oral teratogenicity in the Dutch Belted rabbit
(b)
Hazleton Laboratiries Europe, Harrogate, UK
Report No: 80/0135
GLP: No
unpublished
IIA 5.5.1
Irvine L F H
Tucker M L
1978 MCPA oral teratogenicity dose ranging study in rats
(a)
Hazleton Laboratories Europe, Harrogate, UK
Report No: 78/0158
GLP: No
unpublished
IIA 5.5.1
Irvine L F H
Tucker M L
1978 MCPA oral teratogenicity dose ranging study in rats
(c)
Hazleton Laboratories Europe
Harrogate, UK
Report No: 678R-277/6
GLP: No
unpublished
IIA 5.4.1
Jackson M A
1993 The genetic toxicology of putative nongenotoxic
carcinogens
Mut. Res 296
Report No: 93/11621
GLP: No
published
IIA 5.4.1
Jayasuriya V
U de S
Ratnayake W E
1973 The mutagenic and chromosomal effects on
Drosophila melanogaster of some pesticides
commonly used in Sri Lanka
Ceylon Assoc. for the advancement of Sci. Proceed
29th Annual Session, Colombo
Report No: 73/10131
GLP: No
published
- 60 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 5.9.2
1965 A further case of MCPA poisoning
Johnson H R M
Koumides O
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Brit Med J
Report No: 65/10020
GLP: Yes
published
IIA 5.9.2
Jones D I R
1967 Attempted suicide with herbicide containing MCPA
Arch. Environ Health 14
Report No: 67/10029
GLP: No
published
IIA 5.4.1
Kappas A
1988 On the mutagenic and recombinogenic acitivity of
certain herbicides in Salmonella typhimurium and in
Aspergillus nidulans.
Mut Res 204.
Report No: 88/10544
GLP: No
published
IIA 5.4.1
Kappas A
1987 On the mutagenic and recombinogenic activity in
microbial systems.
Genetics 116
Report No: 87/10817
GLP: No
published
IIA
5.6.2.2
Kappas A
1984 Mutagenicity of herbicides in microbial short-term test
systems
Mut Res 130
Report No: 83/10260
GLP: No
published
IIA
5.6.2.2
Khera K S
1985 Maternal toxicity: a possible etiological factor in
embryo-foetal deaths and foetal malformations of
rodent-rabbit species
Teratology 31
Report No: 85/10360
GLP: No
published
- 61 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA
5.6.2.2
1984 Maternal toxicity: a possible factor in foetal
malformations in mice
Khera K S
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Teratology 29
Report No: 84/10294
GLP: No
published
IIA 5.1.5
Kieczka H
1984 Report on the study of the irritation to the Eye of the
White rabbit based on Draize of an 1.6% aqueous
solution of U 46 M-Fluid (DMA-salt of MCPA)
Generated by: TPH
Submitted by: MCPA Dossier Preparation Working
Group.
Report No: 84/196
GLP: No
unpublished
IIA 5.3.1
Kirsch P
1988 Study on the chronic toxicity and oncogenic potential of
MCPA in rats, administration in the diet over 24
months
BASF Aktiengesellschaft, Ludwighafen Germany
Report No: 88/0191
GLP: Yes
unpublished
IIA 5.2.1
Kirsch P
1985 Report on the study of the toxicity of MCPA in mice
(a) after 4-week administration in the diet (range finding
study)
BASF Aktiengesellshcaft,
Ludwigshafren, Germany
Report No: 85/087
GLP: Yes
unpublished
IIA 5.2.2
Kirsch P
1985 Report on the study of the toxicity of MCPA in rats
(b) after 3-months administration in the diet.
BASF Aktiengesellschaft, Ludwigshafen, Germany
Report No: 85/088
GLP: No
unpublished
- 62 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 5.1.1
1983 Report on the study of acute oral toxicity in rats of
(a) MCPA
Kirsch P
Hildebrand B
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
BASF Aktiengesellschaft, Ludwigshafen, Germany
Report No: 83/108
GLP: No
unpublished
IIA 5.1.2
Kirsch P et al
Hildebrand B
1983 Report on the study of acute dermal toxicity in rats of
(b) MCPA
BASF Aktiengesellschaft, Ludwighafen Germany
Report No: 83/167
GLP: No
unpublished
IIA 5.1.2
Kirsch P
Hildebrand B
1983 Report on the study of the irritation to the intact and
( c) abraded dorsal skin of the White rabbit, based on
Draize
BASF Aktiengesellschaft, Ludwigshafen, Germany
Report No: 83/196
GLP: No
unpublished
IIA 5.1.5
Kirsch P
Hildebrand B
1983 Report on the study of the irritation to the eye of the
(d) White Rabbit, based on Draize
BASF Aktiengesellschaft, Ludwigshafen, Germany
Report No: 83/198
GLP: No
unpublished
IIA 5.1.3
Klimisch H J et al 1986 Acute inhalation toxicity LC50 4 hours (rat), dust
aerosol study of MCPA
BASF Aktiengesellschaft, Ludwigshafen, Germany
Report No: Not given
GLP: Yes
unpublished
IIA 5.8.1
KolmondinHedman B
1983 Studies on phenoxy acid herbicides II. Oral and dermal
uptake and elimination in urine of MCPA in humans
Arch Toxicol 54
Report No: 83/10259
GLP: No
published
- 63 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 5.3.1
1988 Study on the oncogenic potential of MCPA in mice,
administration in the diet over 104 weeks
Kühborth B et al
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
BASF Aktiengesellschaft, Ludwigshafen, Germany
Report No: 88/0324
GLP: Yes
unpublished
IIA
7.1.2/01
Kynoch S R
1977 Acute Percutaneous Toxicity to rabbits of U 46 M-Fluid
Lloyd G K
MCPA Dossier Preparation Working Group
Report No: 7483/D262/77
GLP: No
unpublished
IIA 5.1.5
Kynoch S R
Liggett M P
1977 Irritant effects of U 46 M-Fluid (750 g/l) on rabbit eye
(b) mucosa
Generated by: TPH
Submitted by: TPH
Generated by: MCPA Dossier Preparation Working
Group.
Report No: 6939/264D/77
GLP: No
unpublished
IIA 5.1.5
Kynoch S R
IIA 5.1.6
Lloyd G K
1977 Acute Percutaneous Toxicity to rabbits of U 46 M(a) Fluid.
Generated by: TPH
Submitted by: MCPA Dossier Preparation Working
Group
Report No: 7483/D262/77
GLP: No
unpublished
IIA 5.1.5
Ligget M P
1992 Eye irritation to the rabbit of MCPA DMAS.
(b)
Generated by: Industry Task Force II on MCPA
Research Data
Submitted by: MCPA Dossier Preparation Working
Group
Report No: 920435D/JEL 18/SE
GLP: Yes
unpublished
- 64 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 5.6.1
1974 An autoradiographic study on the distribution of the
herbicide 4-chloro-2-methylphenoxyacetic acid in
pregnant mice.
Lindquist N G
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Toxicol. Appl. Pharmacol
Report No: 74/10201
published
IIA 5.4.1
Linnainmaa K
1984 Induction of sister chromatid exchanges by the
peroxisome proliferators 2,4-D, MCPA and clofibrate in
vivo and in vitro
Carcinogenesis
Report No:84/10268
GLP: No
published
IIA 5.4.1
Linnainmaa K
1983 Sister chromatid exchanges among workers
occupationally exposed to phenoxy acid herbicides
2,4-D and MCPA
Teratog. Carcinog. Mutag
Report No: 83/10262
GLP: No
published
IIA 5.9.2
Lynge E
1987 The evaluation of trends in soft tissue sarcoma
according to diagnostic criteria and consumption of
phenoxy herbicides
BCancer 60
Report No: 87/10726
GLP: No
published
IIA 5.9.2
Lynge E
1985 A follow-up study of cancer incidence among workers
in manufacture of phenoxy herbicides in Denmark.
Br. J Cancer 52
Report No: 85/10433
GLP: No
Published
IIA 5.9.5
Maroni M
Fait A
1993 Health effects in man from long-term exposure to
pesticides
Toxicology 78
Report No: 93/11634
GLP: No
published
- 65 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 5.5.2
1986 Two generation reproduction study with MCPA in rats
MacKenzie K M
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Hazelton Laboratories America Inc, Madison, W I, USA
Report No: 86/420
GLP: Yes
Unpublished
IIA 5.4.3
McGregor D B
1986 4-chloro-2-methyl phenoxy acetic acid:
Association with DNA, RNA and proteins
Inveresk Research International, Messelburgh,
Scotland
Report No: 86/0435
GLP: Yes
unpublished
IIA 5.4.1
MerschSundermann V
1989 Untersuchungen zur Mutagenität organischer
Mikrokontaminationen in der Umwelt III Mitteilung: Die
Mutagenität ausgewählter Herbizide and Insektizide im
SOS-Chromotest
Zbl. Hyg 189
Report No: 89/10805
GLP: No
published
IIA 5.4.1
MerschSundermann V
1988 Untersuchungen zur Mutagenität organischer
Mikrokontaminationen in der Umwelt I Mitteilung: Die
Mutagenität ausgewähler Herbizide and Insektizide im
Salmonella-Mikrosomen-Test (Ames Test) unter
Berücksichtingung der pathogen Potenz kontaminierter
Grund-und-Trinkwässer.
Zbl. Bakt. Hyg B 1869.
Report No: 88/10541
GLP: No
published
IIA 5.4.1
Moriya M
1983 Further mutagenicity studies on pesticides in bacterial
reversion assay systems
Mut. Res 116
Report No: Not given
GLP: No
published
- 66 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 5.4.2
1989 Effects of commercial chlorophenolate, 2,3,7,8-TCDD,
and pure phenoxyacetic acids on hepatic perosixome
proliferation, xenobiotic metabolism and sister
chromatid exchange in the rat.
Mustonen R
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Arch. Toxicol 63
Report No: 89/10808
GLP: No
published
IIA 5.4.2
Mustonen R
1986 Effects of phenoxyacetic acids on the induction of
chromosome aberrations in vitro and in vivo.
Mutagenesis 1
Report No: 86/10407
GLP: No
published
IIA 5.4.1
Nishimura N
1982 Survey on mutagenicity of pesticides by the
Salmonella-microsome test
J Aichi. Med. Univ. Assoc. 10
Report No: 82/10231
GLP: No
published
IIA
Popham R D
Davies D M
1964 A case of MCPA poisoning
Brit Med J. 1
Report No: 64/10013
GLP: No
published
IIA 5.2.2
Reuzel P G J
1980 Subchronic (13-week) oral toxicity study of MCPA in
Beagle Dogs.
TNO Central Inst. For Nutr. And Food Res. Zeist,
Netherlands
Report No: 80/0103
GLP: No
unpublished
IIA 5.2.1
Reuzel P G J
1978 Range-finding (4-week) toxicity study with MCPA in
Beagle Dogs.
TNO Central Inst. For Nutr. And Food Res. Zeist,
Netherlands
Report No: 78/0159
GLP: No
Unpublished
- 67 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 5.6
1983 Vergleichende Untersuchungen zur Embryotoxizität
von 2-Methyl-4-Chlorophenolessigsäure, Mecoprop
und Dichlorprop bei NMRI Mäusen.
Roll R
Mattiaschk G
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Arznei. Forsch 33
Report No: 83/10103
GLP: No
published
IIA 5.2.4
Rush R E
1990 Acute toxicity studies with Rhonox®herbicide
(a)
Acute Toxic data 1
Report No: 90/10899
GLP: No
Published
IIA 5.2.1,
5.2.2,
5.2.3
Rush R E
1990 Acute irritation/sensisation studies with
(b) Rhonox®herbicide.
Acute Toxic Data 1
Report No: 90/10900
GLP: No
Published
IIA 5.8.2
Seiler J P
1979 Phenoxyacids as inhibitors of testicular DNA synthesis
in male mice
Bull. Environ. Contam. Toxicol 21
Report No: 79/10308
GLP: No
Published
IIA 5.4.1
Shirasu Y
1981 Mutagenicity screening studies on pesticides
Environ. Mutagen. Carcin. Proc 3rd Int. Conf
Report No: 82/10230
GLP: No
published
IIA 5.4.1
Shirasu Y
1976 Mutagenicity screening of pesticides in the microbial
system
Mut Res. 40
Report No: 76/10195
GLP: No
Published
- 68 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 5.9.2
1992 Phenoxy acid herbicides and chlorophenols: A case
control study on soft tissue sarcoma and malignant
lymphoma
Smith J G
Chritopher A J
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Br. J Cancer 65
Report No: 92/12298
GLP: No
published
IIA 5.5
Takagi S
1990 Chronic toxicity of 2-methyl-4-chlorophenoxyacetic acid
(MCPA) in mice
Tohuku J Exp. Med 160
Report No: 90/10902
GLP: No
published
IIA 5.3.1
Tyynelä K
1990 Distribution of three common chlorophenoxyacetic acid
herbicides into the rat brain
Arch Toxicol 64
Report No: 90/10901
GLP: No
published
IIA 5.2.4,
5.3.1
Verschuuren P G 1975 Short-term oral and dermal toxicity of MCPA and
MCPP
Toxicology 3
Report No: 75/10240
GLP: No
published
IIA 5.4.1
Vogel E
Chandler J L R
1973 Mutagenicity testing of cyclamate and some pesticides
in Drosphila melanogaster
Experientia 30
Report No: 74/10220
GLP: No
published
IIA 5.9.2
Wiklund K
Holm L E
1986 Soft tissue sarcoma risk in Swedish agricultural and
forestry workers
Natl. Cancer Inst. 76
Report No: 86/10724
GLP: No
published
- 69 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 5.9.2
1987 Risk of malignant lymphoma in Swedish pesticide
appliers
Wiklund K
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Br. J. Cancer 56
Report No: 87/10823
GLP: No
Published
IIA 5.9.2
Yamamoto M
1986 Biliary tract cancer in Japan: A study from the point of
view of enviromental epidemiology.
Acta Meica Biologica 34
Report No: 86/10723
GLP: No
published
IIA 5.4.1
Zetterberg G
1979 Mechanism of the lethal and mutagenic effects of
phenoxyacetic acids in Sacharomyces cerevisae
Mut Res 60
Report No: 79/10307
GLP: No
published
B.7 Residue data
Annex
Author(s)
point/
reference
number
Year
IIA 6.1
1984 The Uptake, Metabolsim and Phytotoxicity of MCPA in
Plants
Achhiereddy N
Kirkwood R C
Fletcher W W
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Journal of Pesticide Science 9 Pp 617-622 IV
Generated by: Published literature
Submitted by: MCPA Dossier Preparation Working
Group
Report No: Not given
GLP: No
published
- 70 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 6.3
1975 Abbaukurve im Weidegras
Anonymous
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Generated by TPH
Wubmitted by: MCPA Dossier Preparation Working
Group
Report No: BAS 010 01H 75/2 A and 75/3 A
GLP: No
unpublished
IIA 6.3
Anonymous
1975 Abbaukurve in Weidegras
Generated by TPH
Submitted by: MCPA Dossier Preparation Working
Group
Report No: BAS 010 01H 75/1A
GLP: No
unpublished
IIA 6.3
Brockelsby C D
1989 Herbicide MCPA: Residue Studies on Oranges Italy
1998
Generated by: Rhöne-Poulenc Agriculture/Nufarm
Submitted by: MCPA Dossier Preparation Working
Group
Report No: 1212
GLP: No
unpublished
IIA 6.3
Brockelsby C D
1989 Herbicide MCPA: Residue Studies on Pears, Italy 1987
Generated by: Rhöne-Poulenc Agriculture/Nufarm
Submitted by: MCPA Dossier Preparation Working
Group
Report No: 1213
GLP: No
unpublished
IIA 6.2
Fryer J D
Kirkland K
1970 Field experiments to investigate long-term effects of
repeated applications of MCPA, Tri-Allate, Simazine
and Linuron: Report after 6 years.
Weed Res. 10 pp 133-158 (VI/47)
Generated by: Published literature
Submitted by: MCPA Dossier Preparation Working
Group
GLP: No
published
- 71 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 6.3
1988 Summary and evaluation of MCPA residue behaviour
(a) in food and feed from plant origin. Residue situation in
viticulture.
Fuchs
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Generated by: BASF Limburgerhof
Submitted by: MCPA Dossier Preparation Working
Group.
Report No: 88/10312 Annex 2
GLP: No
unpublished
IIA 6.3
Fuchs
1988 Summary and evaluation of MCPA residue behaviour
(b) in food and feed from plant origin. Residue situation in
cereals.
Generated by: BASF Limburgerhof.
Submitted by: MCPA Dossier Preparation Working
Group
Report No: 88/10312 Annex I
GLP: No
unpublished
IIA 6.3
Fuchs
1988 Summary and evaluation of MCPA residue behaviour
(c ) in food and feed from plant origin. Residue situation in
cereals.
Generated by: BASF Limburgerhf.
Submitted by: MCPA Dossier Preparation Working
Group
Report No: 88/10312 Annex 2
Unpublished (1968)
Published (1985)
GLP: No
-
IIA 6.3
Fuchs
1988 Summary and evaluation of MCPA residue behaviour
(d) in food and feed from plant origin. Residue situation in
cereals.
Generated by: BASF Limburgerhof
Submitted by: MCPA Dossier Preparation Working
Group.
Report no: 88/10312 Annex 3
GLP: No
unpublished
- 72 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA 6.1
1979 Investigations into the Metabolsim of MCPA in Winter
Wheat.
Keller W
Otto S
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Generated by: BASF AG/TPH
Submitted by: MCPA Dossier
Group
Preparation Working
Report No: 1161a
GLP: No
unpublished
B.8 Environmental fate and behaviour
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA
Balk F
7.2.1.3.1/ Stroo C A
02
1985 Biodegradation of auxine herbicides in an aquatic
system (MCPA)
Generated by: Industry Task Force I on MCPA
Research Data and TPH
Submitted by: MCPA Dossier Preparation Working
Group
Report No: T 84-1-1
GLP: No
published
IIA
Chang J
7.2.1.1/02
1992 Dissociation of MCPA DMAs in water.
Generated by: Industry Task Force II on MCPA
Research Data
Submitted by: MCPA Dossier Preparation Working
Group
Report No: SC920051
GLP: No
unpublished
IIA
Helling C S
7.1.3.1/01
1971 Pesticide Mobility in Soil II. Applications of Soil Thin
Layer Chromatography
Generated by: Published literature
Submitted by: MCPA Dossier Preparation Working
Group.
Report No: Not given
GLP: No
published
- 73 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA
Klöpffer W
7.2.1.2/02
1991 Determination of the Phototransformation in Water of
MCPA according to UBA Test Guideline Direct
Phototransformation.
Submitted by: MCPA Dossier Preparation Working
Group
Report No: BE-P-118-91-PHO-02
GLP: Yes
unpublished
IIA
Kubiak R
7.1.3.3/01
1991 Outdoor Lysimeter Study on 14C-MCPA in 2 different
soils (Final Report)
Generated by: Industry Task Force II on MCPA
Research Data
Submitted by: MCPA Dossier Preparation Working
Group
Report No: 91/11086
GLP: No
unpublished
IIA
Obrist J J
7.1.1.1.3/
01
1987 Photdegradation of MCPA on Soil.
(a)
Generated by: Industry Task Force I on MCPA
Research Data
Submitted by: MCPA Dossier Preparation Working
Group
Report No: HAL 6015-326
GLP: Yes
unpublished
IIA
Smith A E
7.1.1.2/01
1989 Degradation, fate and persistence of phenoxy-alkanoic
acid herbicides in soil.
Rev. Weed Sci. 1989, Volume 4, 1-24
Report No: Not given
GLP: No
published
IIA
Ten Berge W F
7.2.1.3/01 Blok J
1978 Environmental Assessment of auxine herbicides
Generated by: TPH
Submitted by: MCPA Dossier Preparation Working
Group
Report No: Not given
GLP: No
unpublished
- 74 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA
Zohner A
7.1.3.2/01
1988 Determination of the Mobility of Soil-Aged Residues by
Soil Column Leaching Test for 14C-MCPA Acid
Generated by: Industry Task Force I on MCPA
Research Data
Submitted by: MCPA Dossier Preparation Working
Group
Report No: 1012
GLP: Yes
unpublished
B.9 Ecotoxicology
Annex
Author(s)
point/
reference
number
Year
IIA 8.3.2
1988 The Acute Toxicity of U 46 M-Fluid (500g MCPA acid
as Dimethylamine Salt) to Eisenia fetida.
Adema D M M
Roza P
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Report No: R 89/152
GLP: Yes
unpublished
IIIA
10.2.1
Hanstveit A O
1988 Effects of U 46 M-Fluid on growth of the algae,
Selenastrum capricornutum
TPH
Report No: R 88/421
GLP: Yes
unpublished
IIA 8.3.2
König K
1989 Study on the effect of U 46 Combi-Fluid on
Trichogramma cacoecia.
TPH
Report No: 18/89
GLP: unpublished
IIA 8.3.1
SamsoePetersen L
1990 Effects of U 46 Combi-Fluid on Aleochara Bilineata
(Gyll)
TPH
Report No: Not given
GLP: Yes
unpublished
- 75 MCPA-THIOETHYL
APPENDIX IIIB
List of studies
05 April 2005
Annex
Author(s)
point/
reference
number
Year
IIA
8.3.1.1
1987 Poisoning of Honeybees by Pesticides: Investigations
of the Changing Pattern in Britain over 20 years
Stevenson J H
Needham P H
Walker J
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Rothamsted Report for 1977, part 2
Report No: Not given
GLP: No
published
IIA8.5
Torstensson N T
L
1975 The effect of Repeated Applications of 2,4-D and
MCPA on their Breakdown in Soil
Stark J
Weed Research 15
Göransson B
Report No: Not given
GLP: No
published
IIA 8.3.3
Zohner A
1989 Investigation of the Side Effects of U 46 M-Fluid (500
(a) g/l MCPA as DMA salt)
on the ammonification and nitrification
TPH
Report No:
IIA 8.3.3
Zohner A
1989 Study of the Effects of U 46 M-Fluid (500 g/l MCPA as
(b) DMA salt) on soil respiration
TPH
Report No: 984
GLP: Yes
unpublished
MCPA
APPENDIX IV
05 April 2005
APPENDIX IV
Summary of intended uses of MCPA (submitted by the MCPA European Task Force )
Crop and/
or situation
Member
State or
Country
Product
Name
F,
Pests or
G, Group of pests
or I
controlled
Formulation
Type
(a)
(b)
(c)
(d-f)
Conc.
of as
(i)
Application
method
kind
(f-h)
Winter Cereals Wheat, Barley, Rye,
Oats, Triticale
Various
Various
F
Broadleaved
Weeds
High or low volume
spraying with tractor
mounted boom
Spring Cereals Wheat, Barley, Rye
Oats, Triticale
Various
Various
F
Broadleaved
Weeds
High or low volume
spraying with tractor
mounted boom
Grassland
(including Pasture)
Various
Various
F
Broadleaved
Weeds
Turf
(including seed, new
and established )
Various
Various
F
Broadleaved
Weeds
Maize
Various
Various
F
Broadleaved
Weeds
High or low volume
spraying with knapsack
sprayer or tractor
mounted boom
High or low volume
spraying with knapsack
sprayer or tractor
mounted boom
Spray
Application rate per treatment
growth
stage
(j)
number
min max
(k)
Spring,
before first
node
detectable
Spring,
before first
node
detectable
Spring to
early
summer
1
interval
between
applications
(min)
/
1
kg as/hL
water L/ha
kg as/ha
min max
min max
max
PHI
(days)
Remarks:
(l)
(m)
100 – 1000
1.8
/
/
/
100 – 1000
1.8
/
/
2
4 weeks
100 – 1000
1.8
/
/
Spring to
early
summer
3
4 weeks
100 – 1000
1.8
/
/
Plant height
10 – 30 cm
1
N/A
Remarks:
(a) For crops, the EU and Codex classifications (both) should be used; where relevant, the situation should be described (e.g. fumigation of a structure)
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I)
(c) e.g. biting and sucking insects, soil born insects, foliar fungi, weeds
(d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989
(f) All abbreviations used must be explained
(g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench
(h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between plants- type of equipment used must be indicated
(i) g/kg or g/l
(j) Growth stage at last treatment (BBCH Monograph, Growth stages of Plants, 1997, Blackwell, ISBN 3-8263-3152-4); including where relevant, information on season at the time time of application
(k) Indicate the minimum and maximum number of application possible under practical conditions of use
(l) PHI - minimum pre-harvest interval
(m) Remarks may include: Extent of use / economic importance / restrictions
1.05