EFSA Journal 2010;8(9):1715
CONCLUSION ON PESTICIDE PEER REVIEW
Conclusion on the peer review of the pesticide risk assessment of the active
substance 1-decanol1
European Food Safety Authority2
European Food Safety Authority (EFSA), Parma, Italy
SUMMARY
1-Decanol is one of the 295 substances of the fourth stage of the review programme covered by
Commission Regulation (EC) No 2229/2004,3 as amended by Commission Regulation (EC) No
1095/20074. In accordance with the Regulation, at the request of the Commission of the European
Communities (hereafter referred to as „the Commission‟), the EFSA organised a peer review of the
initial evaluation, i.e. the Draft Assessment Report (DAR), provided by Italy, being the designated
rapporteur Member State (RMS). The peer review process was subsequently terminated following the
applicants‟ decision, in accordance with Article 24e, to withdraw support for the inclusion of 1decanol in Annex I to Council Directive 91/414/EEC.
Following the Commission Decision of 8 December 2008 (2008/941/EC)5 concerning the noninclusion of 1-decanol in Annex I to Council Directive 91/414/EEC and the withdrawal of
authorisations for plant protection products containing that substance, the applicants Chemtura Europe
and Drexel Chemical Company made a joint resubmission application for the inclusion of 1-decanol in
Annex I in accordance with the provisions laid down in Chapter III of Commission Regulation (EC)
No. 33/2008.6 The resubmission dossier included further data in response to the issues identified in the
DAR.
In accordance with Article 18 of Commission Regulation (EC) No. 33/2008, the United Kingdom,
being the designated RMS, submitted an evaluation of the additional data in the format of an
Additional Report. The Additional Report was received by the EFSA on 10 December 2009.
In accordance with Article 19 of Commission Regulation (EC) No. 33/2008, the EFSA distributed the
Additional Report to Member States and the applicants for comments on 11 December 2009. The
EFSA collated and forwarded all comments received to the Commission on 26 January 2010.
In accordance with Article 20, following consideration of the Additional Report, the comments
received, and where necessary the DAR, the Commission requested the EFSA to conduct a focused
peer review in the area of mammalian toxicology and deliver its conclusions on 1-decanol.
1 On request from the European Commission, Question No EFSA-Q-2010-00150, issued on 27 August 2010.
2 Correspondence: praper@efsa.europa.eu
3
OJ L 379, 24.12.2004, p.13
4
OJ L 246, 21.9.2007, p.19
5
OJ L 335, 13.12.2008, p.91
6
OJ L 15, 18.01.2008, p.5
Suggested citation: European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the
active substance 1-decanol. EFSA Journal 2010;8(9):1715. [42 pp.] doi:10.2903/j.efsa.2010.1715. Available online:
www.efsa.europa.eu/efsajournal.htm
© European Food Safety Authority, 2010
1
Peer Review of the pesticide risk assessment of the active substance 1-decanol
The conclusions laid down in this report were reached on the basis of the evaluation of the
representative use of 1-decanol as a plant growth regulator on tobacco, as proposed by the applicants.
Full details of the representative use can be found in Appendix A to this report.
Data gaps were identified in the sections identity and analytical methods.
No data gap and no critical area of concern were identified in the mammalian toxicology section.
No significant residues in plant or animal matrices were expected based on the proposed non-food use
and the chemical nature of 1-decanol. Consumer risk assessments were therefore not required due to
the unlikelihood of significant residues.
Information on the rate of degradation of 1-decanol in soil is not available in the applicants‟ dossier.
Information on this is required before the groundwater and surface water exposure assessments can be
finalised.
A high risk to aquatic organisms was identified on the basis of indicative FOCUS step 4 PECsw values.
A data gap was identified to provide a risk assessment for aquatic organisms, once reliable aquatic
exposure data would be available. The risk to bees was considered as low due to negligible exposure
because the product is applied after flowering. Labelling with “Sp8” was considered appropriate in
order to exclude exposure of honeybees from flowering weeds. Based on the available data the risk to
birds and mammals, non-target arthropods, earthworms, non-target soil micro-organisms, non-target
plants and biological methods of sewage treatment was assessed as low for the representative use.
© European Food Safety Authority, 2010
KEY WORDS
1-decanol, decan-1-ol, peer review, risk assessment, pesticide, plant growth regulator
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TABLE OF CONTENTS
Summary .................................................................................................................................................. 1
Table of contents ...................................................................................................................................... 3
Background .............................................................................................................................................. 4
The active substance and the formulated product .................................................................................... 7
Conclusions of the evaluation .................................................................................................................. 7
1. Identity, physical/chemical/technical properties and methods of analysis ...................................... 7
2. Mammalian toxicity ......................................................................................................................... 7
3. Residues ........................................................................................................................................... 8
4. Environmental fate and behaviour ................................................................................................... 8
5. Ecotoxicology .................................................................................................................................. 9
6. Overview of the risk assessment of compounds listed in residue definitions triggering assessment
of effects data for the environmental compartments .............................................................................. 11
6.1.
Soil ........................................................................................................................................ 11
6.2.
Ground water ........................................................................................................................ 11
6.3.
Surface water and sediment .................................................................................................. 12
6.4.
Air ......................................................................................................................................... 12
List of studies to be generated, still ongoing or available but not peer reviewed................................... 13
Particular conditions proposed to be taken into account to manage the risk(s) identified ..................... 13
Issues that could not be finalised ............................................................................................................ 13
Critical areas of concern ......................................................................................................................... 13
References .............................................................................................................................................. 14
Appendices ............................................................................................................................................. 15
Abbreviations ......................................................................................................................................... 40
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BACKGROUND
Legislative framework
Commission Regulation (EC) No 2229/20047, as amended by Commission Regulation (EC) No
1095/20078, lays down the detailed rules for the implementation of the fourth stage of the work
programme referred to in Article 8(2) of Council Directive 91/414/EEC. This regulates for the
European Food Safety Authority (EFSA) the procedure for organising, upon request of the
Commission of the European Communities (hereafter referred to as „the Commission‟), a peer review
of the initial evaluation, i.e. the Draft Assessment Report (DAR), provided by the designated
rapporteur Member State.
Commission Regulation (EC) No 33/20089 lays down the detailed rules for the application of Council
Directive 91/414/EEC for a regular and accelerated procedure for the assessment of active substances
which were part of the programme of work referred to in Article 8(2) of Council Directive
91/414/EEC but which were not included in Annex I. This regulates for the EFSA the procedure for
organising the consultation of Member States and the applicants for comments on the Additional
Report provided by the designated RMS, and upon request of the Commission the organisation of a
peer review and/or delivery of its conclusions on the active substance.
Peer review conducted in accordance with Commission Regulation (EC) No 2229/2004
1-decanol is one of the 295 substances of the fourth stage of the review programme covered by
Commission Regulation (EC) No 2229/2004, as amended by Commission Regulation (EC) No
1095/2007. In accordance with the Regulation, at the request of the Commission, the EFSA organised
a peer review of the DAR provided by the designated rapporteur Member State, Italy, which was
received by the EFSA on 11 February 2008 (Italy, 2007).
The peer review was initiated on 7 April 2008 by dispatching the DAR to Member States and the
applicants Chemtura Europe and Drexel Chemical Company for consultation and comments.
The peer review process was subsequently terminated following the applicants‟ decision, in
accordance with Article 24e, to withdraw support for the inclusion of 1-decanol in Annex I to Council
Directive 91/414/EEC.
Peer review conducted in accordance with Commission Regulation (EC) No 33/2008
Following the Commission Decision of 8 December 2008 (2008/941/EC)10 concerning the noninclusion of 1-decanol in Annex I to Council Directive 91/414/EEC and the withdrawal of
authorisations for plant protection products containing that substance, the applicants Chemtura Europe
and Drexel Chemical Company made a joint resubmission application for the inclusion of 1-decanol in
Annex I in accordance with the provisions laid down in Chapter III of Commission Regulation (EC)
No. 33/2008. The resubmission dossier included further data in response to the issues identified in the
DAR, as follows: physical and chemical properties, mammalian toxicology, residues and
ecotoxicology.
In accordance with Article 18, the United Kingdom, being the designated RMS, submitted an
evaluation of the additional data in the format of an Additional Report. The Additional Report was
received by the EFSA on 10 December 2009 (United Kingdom, 2009).
In accordance with Article 19, the EFSA distributed the Additional Report to Member States and the
applicants for comments on 11 December 2009. In addition, the EFSA conducted a public consultation
7
OJ L 379, 24.12.2004, p.13
OJ L 246, 21.9.2007, p.19
9
OJ L 15, 18.01.2008, p.5
10
OJ L 335, 13.12.2008, p.91
8
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on the Additional Report and the DAR. The EFSA collated and forwarded all comments received to
the Commission on 26 January 2010. At the same time, the collated comments were forwarded to the
RMS for compilation in the format of a Reporting Table. The applicants were invited to respond to the
comments in column 3 of the Reporting Table. The comments and the applicants‟ response were
evaluated by the RMS in column 3.
In accordance with Article 20, following consideration of the Additional Report, the comments
received, and where necessary the DAR, the Commission decided to further consult the EFSA. By
written request, received by the EFSA on 25 February 2010, the Commission requested the EFSA to
arrange a consultation with Member State experts as appropriate and deliver its conclusions on 1decanol within 6 months of the date of receipt of the request, subject to an extension of a maximum of
90 days where further information were required to be submitted by the applicants in accordance with
Article 20(2).
The scope of the peer review and the necessity for additional information, not concerning new studies,
to be submitted by the applicants in accordance with Article 20(2), was considered in a telephone
conference between the EFSA, the RMS, and the Commission on 1 March 2010; the applicants were
also invited to give their view on the need for additional information. On the basis of the comments
received, the applicants‟ response to the comments, and the RMS‟ subsequent evaluation thereof, it
was concluded that the EFSA should organise a consultation with Member State experts in the area of
mammalian toxicology and that further information should be requested from the applicants in the area
of mammalian toxicology.
The outcome of the telephone conference, together with EFSA‟s further consideration of the
comments is reflected in the conclusions set out in column 4 of the Reporting Table. All points that
were identified as unresolved at the end of the comment evaluation phase and which required further
consideration, including those issues to be considered in consultation with Member State experts, and
the additional information to be submitted by the applicants, were compiled by the EFSA in the format
of an Evaluation Table.
The conclusions arising from the consideration by the EFSA, and as appropriate by the RMS, of the
points identified in the Evaluation Table, together with the outcome of the expert discussions where
these took place, was reported in the final column of the Evaluation Table.
A final consultation on the conclusions arising from the peer review of the risk assessment took place
with Member States via a written procedure in July – August 2010.
This conclusion report summarises the outcome of the peer review of the risk assessment on the active
substance and the representative formulation evaluated on the basis of the representative use as a plant
growth regulator on tobacco, as proposed by the applicants. A list of the relevant end points for the
active substance as well as the formulation is provided in Appendix A. In addition, a key supporting
document to this conclusion is the Peer Review Report (EFSA, 2010), which is a compilation of the
documentation developed to evaluate and address all issues raised in the peer review, from the initial
commenting phase to the conclusion. The Peer Review Report comprises the following documents:
•
the comments received,
•
the Reporting Table (revision 1-1; 4 March 2010),
•
the Evaluation Table (23 August 2010),
•
the report(s) of the scientific consultation with Member State experts (where relevant).
Given the importance of the DAR and the Additional Report including its addendum (compiled
version of July 2010 containing all individually submitted addenda) (United Kingdom, 2010) and the
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Peer Review Report, both documents are considered respectively as background documents A and B
to this conclusion.
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THE ACTIVE SUBSTANCE AND THE FORMULATED PRODUCT
1-decanol is a common name (there is no ISO common name assigned) for decan-1-ol (IUPAC).
The representative formulated products for the evaluation were 'Royaltac' and 'Antak 79', both
emulsifiable concentrates (EC) containing 679 g/L and 686 g/L 1-decanol respectively, registered
under different trade names in Europe.
The representative use evaluated comprises applications after first topping for control of primary and
secondary auxiliary shoots in tobacco. Full details of the GAP can be found in the list of end points in
Appendix A.
CONCLUSIONS OF THE EVALUATION
1.
Identity, physical/chemical/technical properties and methods of analysis
The minimum purity of 1-decanol technical is 960 g/kg for both sources. No FAO specification exists.
The assessment of the data package revealed no issues that need to be included as critical areas of
concern with respect to the identity, physical, chemical and technical properties of 1-decanol or the
respective formulations. During the peer review of the Additional Report the toxicological equivalence
of the two sources was established since a joint submission was made using data generated on each
individual technical material in order to provide a complete data package, and it was proposed that
each source of technical material be considered a separate reference source. However, further
information was needed to justify the proposed technical specification of the Chemtura source, and so
the specification for this source should be considered provisional pending the evaluation of these data.
As a consequence a data gap was identified for validation data for the method of analysis for the
organic impurities for the Chemtura source. It should be noted that data are available, however, in
accordance with Article 20(2) of Commission Regulation (EC) No. 33/2008, new studies cannot be
considered in the peer review once the dossier has been submitted.
The main data regarding the identity of 1-decanol and its physical and chemical properties are given in
Appendix A.
Analytical methods are available for the determination of 1-decanol in the technical material and in the
representative formulations. Analytical methods for monitoring residues of 1-decanol in tobacco and
products of animal origin are not required since tobacco is not included in Annex I of Regulation (EC)
No 396/2005 and 1-decanol is listed in Annex IV of the regulation as a substance for which MRLs are
not required. Based on natural occurrence and low toxicity to soil organisms and humans, the
requirements for monitoring methods for the determination of 1-decanol in soil and air are considered
not necessary. However, as 1-decanol can be considered to be very toxic to aquatic organisms, a
monitoring method for the determination of residues of 1-decanol in water was identified as a data
gap. Analytical methods for the determination of residues of 1-decanol in body fluids and tissues are
not required.
2.
Mammalian toxicity
1-decanol was discussed at the PRAPeR Expert‟s Meeting on mammalian toxicology (PRAPeR 76) in
May - June 2010. Both sources of 1-decanol were considered toxicologically equivalent and the
batches used in the toxicological studies were representative of the technical specification. No relevant
impurity was identified in the technical specification.
No specific toxicokinetics study with 1-decanol has been submitted because the toxicokinetic and
metabolism properties of the linear aliphatic alcohols are reasonably well understood. Based on the
available information, 1-decanol is expected to be rapidly and readily absorbed from the
gastrointestinal tract and extensively metabolised to the corresponding fatty acid, which may occur
naturally in humans. 1-decanol is of low acute toxicity by the oral, dermal and inhalation routes. It was
shown to be irritating to eyes and to skin in a repeated (90-day) study in rat; no skin sensitisation was
observed. Short-term, reproductive and developmental NOAELs were based on the highest doses
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tested (with no effect observed). Based on the weight of evidence, no further testing was required,
either on long-term, multigeneration or developmental toxicity in rabbit. 1-decanol did not exhibit
genotoxic, carcinogenic or neurotoxic potential.
No acceptable daily intake (ADI) and no acute reference dose (ARfD) are allocated to 1-decanol and
none are necessary, because of the toxicological profile of the substance. The acceptable operator
exposure level (AOEL) is 10 mg/kg bw/day, based on the developmental study in rat conducted with
fatty alcohol blend (containing 55% of 1-decanol) showing a NOAEL of 1000 mg/kg bw/day, the
highest dose tested, and applying a safety factor of 100.
The estimated operator exposure is below the AOEL when gloves are used during mixing and loading
according to the German model. However, according to the UK POEM model, the use of gloves
during mixing/loading and application, result in an exposure corresponding to 101% of the AOEL.
Low risk is anticipated for workers or bystanders derived from 1-decanol applications. Considering the
volatile properties of 1-decanol, the risk assessment was based on a method of application described in
the Additional Report, with specific hollow-cone nozzles reducing the amount of substance inhaled.
The agreed parameters are representative of 1-decanol in use on tobacco with field size of 2 ha, work
rate of 6 hours and breathing rate of 1 m3/h, which were used for inhalation exposure estimates. For
the remaining calculations, default values of the respective models were kept (i.e. 20 ha/day for the
German model and 50 ha/day for the UK POEM model), which is expected to represent an
overestimate of the actual operator exposure.
3.
Residues
Conventional metabolism and residues data were not considered necessary to support the
representative use of 1-decanol. A literature review confirmed the ubiquitous occurrence of 1-decanol
in the environment. 1-decanol was also concluded to be volatile and non-systemic based on its
chemical nature.
Based on this information and the proposed non-food use, no significant residues in plant or animal
matrices were expected. Therefore data to address the nature and magnitude of residues in food of
plant and animal origin were not required for the representative use.
Consumer risk assessments were not required due to the unlikelihood of significant residues in food.
4.
Environmental fate and behaviour
With the exception of sterile aqueous hydrolysis investigations (which indicate the compound is stable
under sterile conditions) the applicants‟ dossier contained no specific fate and behaviour regulatory
studies where 1-decanol was applied as a test substance. A number of aquatic ecotoxicological tests
with 1-decanol as test substance were available with analytical measurements that enabled some
estimates of degradation rates in non-sterile aqueous systems to be made. This information indicates
that in aqueous systems the substance exhibits low persistence. In addition to these more specific
investigations, information from the published scientific literature provided credible indications of the
route of degradation for a range of aliphatic alcohols, including 1-decanol, in the environment. These
literature references also indicate that 1-decanol and related aliphatic alcohols are components of cell
membranes of living organisms, so are already present in the environment. It was concluded that these
data were sufficient to indicate that in soil and natural sediment water systems, breakdown products of
1-decanol (i.e. shorter chain aliphatic compounds) did not necessitate specific exposure and risk
assessments to be completed, (as it might be expected that the risk assessment for the active substance,
would also cover the risk from these breakdown products). However the applicants‟ dossier (including
the published scientific literature that they provided) contained no information on the rate of
degradation of 1-decanol in soil. This information is essential to complete the necessary groundwater
and surface water exposure assessments for 1-decanol. Consequently this is indicated in the list of
studies to be generated section of this conclusion. Information on the mobility of 1-decanol in soil (a
quantitative structure-activity relationship QSAR) indicated that 1-decanol might exhibit high
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mobility, but based on other physical chemical properties that have been measured (water solubility of
9 to 10 mg/L at 20ºC, octanol/water partition coefficient Log Pow 4.11 at 22ºC) this adsorption
estimate is expected to underestimate true adsorption, however could be used to provide a
conservative approach for a leaching assessment.
It is acknowledged that the Additional Report includes appropriately calculated PECs in surface water
and sediment using FOCUS (FOCUS 2001, 2007 and 2008) approaches up to step 411 and
groundwater using FOCUS 2000 (FOCUS, 2000)12 approach. However, as these calculations use a soil
half-life of 10 days, which is not supported by any credible data, they should not be relied upon and
are not included in Appendix A of this conclusion. These not relied on PECs in groundwater and the
relied on initial PEC in soil (see Appendix A), utilise a crop interception value of 90%, leaving only
10% of the applied dose reaching the soil. Whilst this is likely to be a reasonable assumption for high
volume spraying, where the application technique applies amounts that aim to minimise foliar runoff,
it should also be noted that there will be uncertainty as to how easy it will be in practice to minimise
foliar runoff.
Whilst 1-decanol is volatile (vapour pressure 1.39 Pa at 25ºC), and so will move from plants, soil and
water to air, calculations using the QSAR methods of Atkinson, as recommended in FOCUS 2008
(FOCUS, 2008), indicate that it is unlikely to be subject to long-range atmospheric transport. (The
calculated half-life as a result of indirect photolysis reactions with hydroxyl radicals in the upper
atmosphere is estimated to be less than 2 days (8.3 hours)).
5.
Ecotoxicology
The acute- and short-term risk to insectivorous birds via dietary exposure was assessed as high at tier 1
for the representative use in tobacco. The risk assessment was refined according to the EFSA opinion
on the science behind the guidance document on risk assessment for birds and mammals (EFSA,
2008). In the opinion it is indicated that it is permissible to extrapolate LD50 values upwards in cases
where no mortality or a single mortality is observed at the limit dose in acute avian toxicity studies. In
both acute- and short-term tests 120 birds were tested, and no mortalities were observed. Therefore,
the original LD50 could be adjusted by multiplying the top dose by 1.88. Based on new LD50/LC50
acute- and short-term TERs were above the Annex VI trigger values, indicating a low acute and shortterm risk to insectivorous birds.
The long-term risk to birds and mammals was assessed as low due to the rapid metabolism of fatty
alcohols and 1-decanol by birds and mammals, and due to reduced exposure following assimilation by
microbial organisms (with degradation half-lives that range from a few hours to 3-5 days).
Furthermore, data concerning the environmental fate and behaviour (see section 4) of 1-decanol
established that it is highly volatile and may be readily biodegradable. Although a first tier risk
assessment identified a potential high risk to birds and mammals from consumption of contaminated
drinking water the risk was eventually considered to be low due to the low toxicity and high volatility
of 1-decanol.
1-decanol is very toxic to aquatic organisms. Rainbow trout (Oncorhynchus mykiss) was the most
sensitive aquatic species when exposed to the active substance on the long-term timescale, driving the
aquatic risk assessment. As no reliable exposure data were available (see section 4) a data gap was
identified to provide a risk assessment for aquatic organisms, once reliable aquatic exposure data are
available. Based on the currently available indicative FOCUS step 4 PECsw values a 20m no-spray
buffer zone would not be sufficient as a risk mitigation measure. Therefore a high risk to aquatic
organisms was indicated and a data gap was identified to address the risk to aquatic organisms. Data
on the toxicity of the formulated product should also be submitted since no studies with the
11
Simulations correctly utilised the agreed Q10 of 2.58 (following EFSA, 2007) and Walker equation coefficient of 0.7.
Simulations complied with EFSA (EFSA, 2004) and correctly utilised the agreed Q10 of 2.58 (following EFSA, 2007) and
Walker equation coefficient of 0.7.
12
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formulation were made available and a high risk to aquatic organisms was indicated based on toxicity
data for the technical active substance.
Whereas the off-field risk regarding the use on tobacco was assessed as low for the two standard nontarget arthropods test species Aphidius rhopaloshipi and Typhlodromus pyri, the in-field risk was
assessed as high for both test species. The in-field risk to A. rhopalosiphi and T. pyri was addressed
based on a higher tier aged-residue studies.
The risk to bees was assessed as low based on the low exposure of 1-decanol to bees expected from
the representative use after flowering. However, bees may be exposed to the active substance by
visiting flowering weeds present in the crop at time of application, and therefore EFSA considers it
necessary to use the restriction phrase Sp8 to exclude the exposure of bees.
Based on the available data, the risk to earthworms, non-target soil micro-organisms, non-target plants
and biological methods for sewage treatment was assessed as low for the representative use.
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6.
Overview of the risk assessment of compounds listed in residue definitions triggering assessment of effects data for the environmental
compartments
6.1.
Soil
Compound
(name and/or code)
Persistence
Ecotoxicology
1-decanol
Data gap
The risk of 1-decanol to earthworms and soil microorganisms was assessed as low.
6.2.
Ground water
Compound
(name and/or code)
>0.1 μg/L 1m depth for
the representative uses
Mobility in soil
(at least
scenario
lysimeter)
one
or
FOCUS
relevant
Pesticidal activity
Toxicological relevance
Ecotoxicological activity
Yes
1-decanol is very toxic to
aquatic organisms. The
risk assessment could not
be finalised.
On the basis of the
available QSAR estimate:
High mobility
1-decanol
Kdoc 96 mL/g.
This
estimate is expected to
have high uncertainty and
probably underestimates
the adsorption potential.
EFSA Journal 2010;8(9):1715
Data gap
Yes
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6.3.
Surface water and sediment
Compound
(name and/or code)
Ecotoxicology
1-decanol
1-decanol is very toxic to aquatic organisms. The risk assessment could not be finalised.
6.4.
Air
Compound
(name and/or code)
Toxicology
1-decanol
Rat LC50 inhalation > 2.05 mg/L air, 4 h (as aerosol, nose-only administration), no classification is proposed
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LIST OF STUDIES TO BE GENERATED, STILL ONGOING OR AVAILABLE BUT NOT PEER
REVIEWED
Validation data for the method of analysis for the organic impurities for the Chemtura Europe Ltd.
source. (relevant for the representative use evaluated; information already submitted, but in
accordance with Article 20(2) of Commission Regulation (EC) No. 33/2008, was not considered
in the peer-review; see section 1)
Monitoring method for the determination of residues of 1-decanol in water. (relevant for the
representative use evaluated; submission date proposed by the applicants: unknown; see section 1
and 5)
Information on the rate of aerobic degradation of 1-decanol in soil is not available. (relevant for
the representative use evaluated; submission date proposed by the applicants: unknown; see
section 4)
Calculation of predicted environmental concentrations (PEC) for the active substance 1-decanol
in surface water and sediment (required for the aquatic risk assessment) and PEC in groundwater
(required for comparison against the parametric drinking water standard) are outstanding and
cannot be carried out whilst the rate of aerobic degradation of 1-decanol in soil is not available.
(relevant for the representative use evaluated; submission date proposed by the applicants:
unknown; see section 4)
The risk to aquatic organisms needs to be addressed further including aquatic toxicity studies with
the formulated product. (relevant for the representative use evaluated; submission date proposed
by the applicants: unknown; see section 5)
PARTICULAR CONDITIONS PROPOSED TO BE TAKEN INTO ACCOUNT TO MANAGE THE RISK(S)
IDENTIFIED
Operator exposure is below the AOEL if personal protective equipment is worn (gloves during
mixing and loading) according to the German model; the product must be used with the particular
method of application described in the Additional Report (see section 2).
The available environmental exposure assessment has been carried out following the assumption
that only 10% of the applied dose reaches the soil, as a result of a good agricultural practice using
high volume spraying where the application technique applies amounts that aim to minimise foliar
runoff. This would therefore be appropriate to specify as a particular condition of use. However
there will be uncertainty as to how easy it will be in practice to minimise any foliar runoff (see
section 4).
Restriction phrase Sp8 should be applied to exclude the exposure to honeybees: “Dangerous to
bees/To protect bees and other pollinating insects do not apply to crop when in flower/Do not use
where bees are actively foraging/Remove or cover beehives during application and for (state time)
after treatment /Do not apply when flowering weeds are present/Remove weeds before
flowering/Do not apply before (state time)” (see section 5).
ISSUES THAT COULD NOT BE FINALISED
The groundwater, surface water and sediment exposure assessments are not finalised. Consequently
the aquatic risk assessment for the active substance was not finalised.
CRITICAL AREAS OF CONCERN
A high risk to aquatic organisms was identified based on indicative non reliable PECsw at FOCUS step
4 with 20m of non-spay buffer zone.
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REFERENCES
EFSA (European Food Safety Authority), 2004. Opinion of the Scientific Panel on Plant Health, Plant
Protection Products and their Residues on a request of EFSA related to FOCUS groundwater
models comparability and the consistency of this risk assessment of groundwater contamination.
The EFSA Journal (2004) 93, 1-20.
EFSA (European Food Safety Authority), 2007. Scientific Opinion of the Panel on Plant Protection
Products and their Residues on a request from EFSA related to the default Q10 value used to
describe the temperature effect on transformation rates of pesticides in soil. The EFSA Journal
(2007) 622, 1-32.
EFSA (European Food Safety Authority), 2008. Scientific Opinion of the Panel on Plant protection
products and their Residues on the Science behind the Guidance Document on Risk Assessment
for birds and mammals. The EFSA Journal (2008) 734, 1-181.
EFSA (European Food Safety Authority), 2010. Peer Review Report to the conclusion regarding the
peer review of the pesticide risk assessment of the active substance 1-decanol.
FOCUS, 2000. “FOCUS Groundwater Scenarios in the EU review of active substances”. Report of
the FOCUS Groundwater Scenarios Workgroup, EC Document Reference SANCO/321/2000rev.2. 202 pp, as updated by the Generic Guidance for FOCUS groundwater scenarios, version 1.1
dated April 2002.
FOCUS, 2001. “FOCUS Surface Water Scenarios in the EU Evaluation Process under 91/414/EEC”.
Report of the FOCUS Working Group on Surface Water Scenarios, EC Document Reference
SANCO/4802/2001-rev.2. 245 pp.
FOCUS, 2007. “Landscape And Mitigation Factors In Aquatic Risk Assessment. Volume 1. Extended
Summary and Recommendations”. Report of the FOCUS Working Group on Landscape and
Mitigation Factors in Ecological Risk Assessment, EC Document Reference SANCO/10422/2005
v2.0. 169 pp.
FOCUS, 2008. “Pesticides in Air: Considerations for Exposure Assessment”. Report of the FOCUS
Working Group on Pesticides in Air, EC Document Reference SANCO/10553/2006 Rev 2 June
2008.
Italy, 2007. Draft Assessment Report (DAR) on the active substance 1-decanol prepared by the
rapporteur Member State Italy in the framework of Directive 91/414/EEC, November 2007.
United Kingdom, 2009. Additional Report to the Draft Assessment Report on the active substance 1decanol prepared by the rapporteur Member State the United Kingdom in the framework of
Commission Regulation (EC) No 33/2008, December 2009.
United Kingdom, 2010. Final Addendum to the Additional Report on 1-decanol, compiled by EFSA,
July 2010.
EFSA Journal 2010;8(9):1715
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Peer Review of the pesticide risk assessment of the active substance 1-decanol
APPENDICES
APPENDIX A – LIST OF END POINTS FOR THE ACTIVE SUBSTANCE AND THE REPRESENTATIVE
FORMULATION
Identity, Physical and Chemical Properties, Details of Uses, Further Information
Active substance (ISO Common Name) ‡
1-decanol (no ISO common name was assigned, this is
the CA name)
Function (e.g. fungicide)
Plant growth regulator
Rapporteur Member State
United Kingdom
Co-rapporteur Member State
Not applicable
Identity (Annex IIA, point 1)
Chemical name (IUPAC) ‡
decan-1-ol
Chemical name (CA) ‡
1-decanol
CIPAC No ‡
831
CAS No ‡
112-30-1
EC No (EINECS or ELINCS) ‡
203-956-9 (EINECS)
FAO Specification (including year of publication) ‡
Not applicable
Minimum purity of the active substance as
manufactured ‡
96.0 % w/w
Identity of relevant impurities (of toxicological,
ecotoxicological and/or environmental concern) in
the active substance as manufactured
None
Molecular formula ‡
CH3(CH2)9OH
Molecular mass ‡
158.28 g/mol
(960 g/kg)
Structural formula ‡
OH
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Physical and chemical properties (Annex IIA, point 2)
Melting point (state purity) ‡
6.66 °C (98.8 %)
Boiling point (state purity) ‡
231.35 °C (98.8 %)
Temperature of decomposition (state purity)
The sample did not sublime and there was no thermal
decomposition up to 400 °C.
Appearance (state purity) ‡
Pure (100 %): colourless to light yellow viscous liquid
TGAI (99.2 %): Colourless oily liquid
Vapour pressure (state temperature, state purity) ‡
1.387 ± 0.253 Pa at 25.3 °C (99.2 %)
Henry‟s law constant ‡
22.52 Pa m3 mol-1
Solubility in water (state temperature, state purity
and pH) ‡
Solubility at 20 °C (98.8 %)
pH
Solubility g/L
4
0.00875
7
0.00975
10
0.01014
Solubility at 20 °C (98.8)
Solvent
Solubility
n-Heptane
>250 g/L
p-Xylene
>250 g/L
Dichloroethane
>250g/L
Methanol
>250 g/L
Acetone
>250g/L
Ethyl Acetate
>250 g/L
Solubility in organic solvents ‡
(state temperature, state purity)
Surface tension ‡
(state concentration and temperature, state purity)
Neat specimen
20°C
30.2 mN/m
40°C
29.9 mN/m
Saturated solution in water
20°C
30.9 mN/m
40°C
31.2 mN/m
(98.8 %)
Partition co-efficient ‡
(state temperature, pH and purity)
Experimental value:
Log Pow = 4.115 at 22 °C (98.8 %)
A Log Pow of 3.79 was estimated using the KOWWIN
program (version 1.67) from the EPI Suite software.
Dissociation constant (state purity) ‡
pKa = 15.21 (estimated value)
UV/VIS absorption (max.) incl. ‡
(state purity, pH)
Neutral solution (pH 7.01)
Absorption maxima = 192 nm
Extinction coefficient = 26.3 L mol-1cm-1
Acidic solution (pH 1.89)
Absorption maxima = 197 nm
Extinction coefficient = 6.66 L mol-1cm-1
Basic solution (pH 11.23)
Absorption maxima = 192 nm
Extinction coefficient = 21.3 L mol-1cm-1
(98.8 %)
Flammability ‡ (state purity)
Flammability: Not required for liquids
Flash point: 110 °C (98.8 %)
Explosive properties ‡ (state purity)
Not-explosive
Oxidising properties ‡ (state purity)
Not-oxidising
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Summary of representative uses evaluated (1-decanol)*
Crop and/
or situation
Member
State
or
Country
Product
name
F
G
or
I
Pests or
Group of
pests
controlled
(b)
(c)
Preparation
Type
(a)
Conc.
of as
method
kind
growth
stage & season
(d-f)
(i)
Application rate per
treatment
(for explanation see the text
in front of this section)
Application
(f-h)
number
min/
max
(j)
interval
between
applications
(min)
kg as/hL
min –
max
(l)
min –
max
min –
max
(l)
(k)
Tobacco
EU
Antak
79
F
Tobacco
EU
Royaltac
F
Tobacco
lateral
shoots
(suckers)
Tobacco
lateral
shoots
(suckers)
EC
EC
79.0%
w/w
(686 g
a.s./L)
78.4%
(679 g
a.s./L)
water
L/ha
PHI
(days)
Remarks
kg as/ha
(m)
High
volume
spraying
After first
topping
1 to 2
10 days
3.430
400
13.7
-
[I]
High
volume
spraying
After first
topping
1 to 2
10 days
3.430
400
13.7
-
[I]
[I] The groundwater, surface water and sediment exposure assessment are not finalised. Consequently the aquatic risk assessment was not finalised. It should be noted that a high risk to aquatic organisms was identified based
on indicative non-reliable PECsw at FOCUS step 4 with 20m of non-spay buffer zone.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
For uses where the column "Remarks" is marked in grey further consideration is necessary.
Uses should be crossed out when the notifier no longer supports this use(s).
For crops, the EU and Codex classifications (both) should be taken into account; where relevant, the use
situation should be described (e.g. fumigation of a structure)
Outdoor or field use (F), greenhouse application (G) or indoor application (I)
e.g. biting and suckling insects, soil born insects, foliar fungi, weeds
e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)
GCPF Codes - GIFAP Technical Monograph No 2, 1989
All abbreviations used must be explained
Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench
Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plant- type of equipment
used must be indicated
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(i) g/kg or g/L. Normally the rate should be given for the active substance (according to ISO) and not for
the variant in order to compare the rate for same active substances used in different variants (e.g.
fluoroxypyr). In certain cases, where only one variant is synthesised, it is more appropriate to give
the rate for the variant (e.g. benthiavalicarb-isopropyl).
(j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 38263-3152-4), including where relevant, information on season at time of application
(k) Indicate the minimum and maximum number of application possible under practical conditions of use
(l) The values should be given in g or kg whatever gives the more manageable number (e.g. 200 kg/ha
instead of 200 000 g/ha or 12.5 g/ha instead of 0.0125 kg/ha
(m) PHI - minimum pre-harvest interval
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Peer Review of the pesticide risk assessment of the active substance 1-decanol
Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)
Technical as (analytical technique)
GC-FID (both notifiers)
Impurities in technical as (analytical technique)
Outstanding data (Chemtura)
GC-MS and GC-FID (Drexel)
Plant protection product (analytical technique)
GC-FID (both notifiers)
Analytical methods for residues (Annex IIA, point 4.2)
Residue definitions for monitoring purposes
Food of plant origin
Not required
Food of animal origin
Not required
Soil
Not required
Water
surface
1-decanol
drinking/ground
1-decanol
Air
Not required
Monitoring/Enforcement methods
Food/feed of plant origin (analytical technique and
LOQ for methods for monitoring purposes)
Not required. Tobacco is not included in Annex I of
Regulation (EC) No 396/2005. Furthermore, MRLs are
not required for 1-decanol.
Food/feed of animal origin (analytical technique
and LOQ for methods for monitoring purposes)
Not required.
Soil (analytical technique and LOQ)
Not required.
Water (analytical technique and LOQ)
Outstanding data
Air (analytical technique and LOQ)
Not required.
Body fluids and tissues (analytical technique and
LOQ)
Not required.
Classification and proposed labelling with regard to physical and chemical data (Annex IIA,
point 10)
RMS/peer review proposal
Active substance
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None
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Peer Review of the pesticide risk assessment of the active substance 1-decanol
Impact on Human and Animal Health
Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point 5.1)
Rate and extent of oral absorption ‡
Rapid and extensive (at least 80 % of administered dose
is expected)
Distribution ‡
Assumed to widespread
Potential for accumulation ‡
Low
Rate and extent of excretion ‡
Not established
Metabolism in animals ‡
Metabolised to the corresponding fatty acid, which is
further metabolized by β oxidation. The end products of
this process will be utilised for energy via the citric acid
cycle or converted to acetoacetate and subsequently to
other ketone bodies which can be excreted in the urine.
Alternatively, 1-decanol or the corresponding fatty acid
can undergo conjugation and subsequent urinary
excretion.
Toxicologically relevant compounds ‡
(animals and plants)
1-decanol
Toxicologically relevant compounds ‡
(environment)
1-decanol
Acute toxicity (Annex IIA, point 5.2)
Rat LD50 oral ‡
> 5000 mg/kg bw
Rat LD50 dermal ‡
> 5000 mg/kg bw
Rat LC50 inhalation ‡
> 2.05 mg/L air 4 h (as aerosol, nose-only
administration)
Skin irritation ‡
Not irritating
Eye irritation ‡
Irritating
Skin sensitisation ‡
Not sensitising (Buehler test)
R36
Short term toxicity (Annex IIA, point 5.3)
Target / critical effect ‡
Via oral: no effect is observed
Via dermal: Site of contact irritation
Relevant oral NOAEL ‡
1000 mg/kg bw/day, based on the observation
of no effects at the highest dose level tested in a
rat developmental toxicity on a structurally
related fatty alcohol blend (1-dodecanol) and no
effects at higher dose levels in a study
conducted on another structurally related
substance (1-hexadecanol).
Relevant dermal NOAEL ‡
90-day, rat: A LOAEL(local) of 100 mg/kg
bw/day is identified, based on the observation of
severe local dermal irritation and secondary
effects on bodyweights at the lowest dose level
tested
Relevant inhalation NOAEL ‡
57 mg/m3 for 7 h/day, gestation days 1-19,
based on the observation of no effects at the
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R38
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Peer Review of the pesticide risk assessment of the active substance 1-decanol
highest dose level tested in a rat developmental
toxicity study
Genotoxicity ‡ (Annex IIA, point 5.4)
Not genotoxic
Long term toxicity and carcinogenicity (Annex IIA, point 5.5)
Target/critical effect ‡
Not determined
Relevant NOAEL ‡
Not determined
Carcinogenicity ‡
Low concern, based on weight of evidence
assessment
Reproductive toxicity (Annex IIA, point 5.6)
Reproduction toxicity
Reproduction target / critical effect ‡
No effect observed up to the highest dose tested,
based on the results of a
reproductive/developmental toxicity screening
test in rats on a structurally related substance (1dodecanol)
Relevant parental NOAEL ‡
2047 mg/kg bw/day
Relevant reproductive NOAEL ‡
2047 mg/kg bw/day
Relevant offspring NOAEL ‡
2047 mg/kg bw/day
Developmental toxicity
Developmental target / critical effect ‡
No effect observed up to the highest dose tested
(on maternal and developmental toxicity), based
on the results of rat developmental toxicity
studies. No rabbit developmental toxicity study
has been submitted; none is required
Relevant maternal NOAEL ‡
Rat: 1000 mg/kg bw/day
Relevant developmental NOAEL ‡
Rat: 1000 mg/kg bw/day
Neurotoxicity (Annex IIA, point 5.7)
Acute neurotoxicity ‡
No neurotoxicity seen in the standard acute
toxicity studies (Annex IIA, point 5.2)
Repeated neurotoxicity ‡
No neurotoxicity seen in the standard repeat
dose toxicity studies (Annex IIA, points 5.3 &
5.6)
Delayed neurotoxicity ‡
Not expected, based on chemical structure
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Other toxicological studies (Annex IIA, point 5.8)
Mechanism studies ‡
No data available – not required
Studies performed on metabolites or impurities ‡
No data available – not required
Medical data ‡ (Annex IIA, point 5.9)
Dermal irritation reported in cases where good hygiene
practices were not followed.
Summary (Annex IIA, point 5.10)
Value
Study
Safety factor
ADI ‡
Not allocated –
not required
AOEL ‡
10 mg/kg bw/day
Developmental
study in rat with
fatty alcohol blend
(containing 55% 1decanol)
100*
ARfD ‡
No allocated –
not required
-
-
*No correction for oral absorption
Dermal absorption ‡ (Annex IIIA, point 7.3)
Formulation (Royaltac, Antac 79, EC)
100% (default value)
Exposure scenarios (Annex IIIA, point 7.2)
Operator
Application by shrouded boom sprayer. 20 L product/ha
(13.72 kg 1-decanol/ha)
German model (20 ha/day work rate*)
% of AOEL
Without PPE:
With PPE (gloves for M/L)
180%
87%
With PPE (gloves for M/L and gloves, coverall and
sturdy footwear during application)
13%
UK POEM (10 L container wide neck aperture (63 mm),
100 M/L operations, 50 ha/day work rate*)% of AOEL
Workers
EFSA Journal 2010;8(9):1715
Without PPE
817%
With PPE (gloves for M/L)
302%
With PPE (gloves for M/L and application)
101%
27% for workers hand harvesting tobacco for 8 hrs
(without PPE)
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Peer Review of the pesticide risk assessment of the active substance 1-decanol
Bystanders
Spray drift – assuming a 70% drift reduction, bystander
exposure predicted at < 1% of the AOEL
Exposure to volatilised pesticide – 14% of AOEL based
on consensus-PEARL
Spray drift fallout into adjacent properties - assuming
70% drift reduction, children‟s exposure predicted at
<1% of AOEL
* The correct value should be 2 ha/day (used in
estimation of inhalation exposure), but default values of
the models were maintained resulting in operator
exposure overestimations.
Classification and proposed labelling with regard to toxicological data (Annex IIA, point 10)
RMS/peer review proposal
Substance classified: 1-decanol
Xi
“Irritant”
R36/38 “irritating to eyes and skin”
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Residues
Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6)
Plant groups covered
Not required.
Rotational crops
Not required.
Metabolism in rotational crops similar to
metabolism in primary crops?
Not applicable.
Processed commodities
Not required.
Residue pattern in processed commodities similar
to residue pattern in raw commodities?
Not applicable.
Plant residue definition for monitoring
No monitoring definition proposed due to natural
occurrence in many plant/environmental matrices.
Plant residue definition for risk assessment
No definition for risk assessment proposed as the
notified use is for a non-food crop.
Conversion factor (monitoring to risk assessment)
Not applicable.
Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6)
Animals covered
Not required.
Time needed to reach a plateau concentration in
milk and eggs
Not required.
Animal residue definition for monitoring
No monitoring definition proposed due to natural
occurrence in many plant/environmental matrices.
Animal residue definition for risk assessment
No definition for risk assessment proposed as the
notified use is for a non-food crop that is not fed to
animals.
Conversion factor (monitoring to risk assessment)
Not applicable.
Metabolism in rat and ruminant similar (yes/no)
Not applicable.
Fat soluble residue: (yes/no)
Log Pow ≥ 3.79
Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5)
Not required.
Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 Introduction)
Not required.
Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3)
Ruminant:
Poultry:
Pig:
Conditions of requirement of feeding studies
Expected intakes by livestock 0.1 mg/kg diet
(dry weight basis) (yes/no - If yes, specify the
level)
EFSA Journal 2010;8(9):1715
No
No
No
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Peer Review of the pesticide risk assessment of the active substance 1-decanol
Potential for accumulation (yes/no):
n/a
n/a
n/a
Metabolism studies indicate potential level of
residues ≥ 0.01 mg/kg in edible tissues (yes/no)
n/a
n/a
n/a
Feeding studies (Specify the feeding rate in cattle and
poultry studies considered as relevant)
Residue levels in matrices : Mean (max) mg/kg
Muscle
n/a
n/a
n/a
Liver
n/a
n/a
n/a
Kidney
n/a
n/a
n/a
Fat
n/a
n/a
n/a
Milk
n/a
Eggs
EFSA Journal 2010;8(9):1715
n/a
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Peer Review of the pesticide risk assessment of the active substance 1-decanol
Summary of residues data according to the representative uses on raw agricultural commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA,
point 8.2)
Crop
Northern or
Mediterranean
Region, field or
glasshouse, and
any other useful
information
Trials results relevant to the
representative uses
(a)
Recommendation/comments
MRL estimated
from trials
according to the
representative use
HR
STMR
(c)
(b)
No supervised residues trials for 1-decanol have been carried out since tobacco is classified as a non-food crop for which a consumer risk assessment is not required.
MRLs are not required as tobacco is not included in the commodity list (Annex I) of the MRL Regulation [Regulation (EC) 178/2006 of 1 February 2006] and therefore residues
data are not relevant for MRL-setting purposes.
(a) Numbers of trials in which particular residue levels were reported e.g. 3 x <0.01, 1 x 0.01, 6 x 0.02, 1 x 0.04, 1 x 0.08, 2 x 0.1, 2 x 0.15, 1 x 0.17
(b) Supervised Trials Median Residue i.e. the median residue level estimated on the basis of supervised trials relating to the representative use
(c) Highest residue
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Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8)
ADI
None required
TMDI (% ADI) according to WHO European diet
No assessment made.
TMDI (% ADI) according to national (to be
specified) diets
No assessment made.
IEDI (WHO European Diet) (% ADI)
No assessment made.
NEDI (specify diet) (% ADI)
No assessment made.
Factors included in IEDI and NEDI
Not applicable.
ARfD
None required
IESTI (% ARfD)
No assessment made.
NESTI (% ARfD) according to national (to be
specified) large portion consumption data
No assessment made.
Factors included in IESTI and NESTI
Not applicable.
Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4)
Crop/ process/ processed product
Number of studies
Processing factors
Transfer
factor
Yield
factor
Amount
transferred (%)
(Optional)
Not required.
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Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
MRLs are not required as tobacco is not included in the commodity list (Annex I) of the MRL Regulation
[Regulation (EC) 178/2006 of 1 February 2006]. In addition, 1-decanol is a naturally-occurring compound and
therefore the origin of residues could not be conclusively attributed to the authorised use of 1-decanol as a
plant growth regulator.
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Fate and behaviour in the environment
Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)
Mineralization after 100 days ‡
Not applicable. No studies submitted and none required.
Non-extractable residues after 100 days ‡
Not applicable. No studies submitted and none required.
Metabolites requiring further consideration ‡
- name and/or code, % of applied (range and
maximum)
No studies submitted and none required. Literature
review provided which indicated that no significant
metabolites are formed.
Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)
Anaerobic degradation ‡
Mineralization after 100 days
Not applicable. No studies submitted and none required.
Non-extractable residues after 100 days
Not applicable. No studies submitted and none required.
Metabolites that may require further consideration
for risk assessment - name and/or code, % of
applied (range and maximum)
No studies submitted and none required. Literature
review provided which indicated that no significant
metabolites are formed.
Soil photolysis ‡
Metabolites that may require further consideration
for risk assessment - name and/or code, % of
applied (range and maximum)
Not applicable. Literature review provided which
indicated that soil photolysis is not a significant route of
degradation for 1-decanol in soil.
Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)
Data gap for information on the rate of aerobic degradation of 1-decanol in soil.
No laboratory or field studies were submitted. Based on a literature review, whilst there were indications in
aqueous systems and conditions of sewage treatment that the aerobic and anaerobic degradation would be
expected to be rapid, no credible information on rate of degradation in soil was identified. 1-decanol is expected
to be stable to soil photolysis.
Soil adsorption/desorption (Annex IIA, point 7.1.2)
No studies submitted and none required.
Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)
Calculated Koc
Software programme: PCKOCWIN vers. 1.66
Calculated Koc: 96.17 mL/ g*
*Other phys/ chem. properties data indicate that the software does not give a reliable prediction for this class of
compounds and that the true value is likely to be higher. However the RMS considers that the value of 96.17
mL/ g is likely to be a worst case for leaching (See Additional report, Section B.8.2 for full discussion)
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PEC (soil) (Annex IIIA, point 9.1.3)
Parent
Assumption of no degradation between applications.
Method of calculation
Application data
Crop: tobacco
Depth of soil layer: 5 cm
Soil bulk density: 1.5 g/ cm3
% plant interception: 90 %
Number of applications: 2
Interval (d): 10
Application rate(s): 13.7 kg as/ha
PEC(s)
(mg/kg)
Initial
Single
application
Single
application
Multiple
application
Multiple
application
Actual
Time weighted
average
Actual
Time weighted
average
1.83
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3.65
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Route and rate of degradation in water (Annex IIA, point 7.2.1)
Hydrolytic degradation of the active substance and
metabolites > 10 % ‡
pH 5: 3.4 % 1-decanol hydrolysed after 5 days at 50 oC.
Considered stable under environmental conditions.
pH 7: 8.3 % 1-decanol hydrolysed after 5 days at 50 oC.
Considered stable under environmental conditions.
pH 9: 4.0 % 1-decanol hydrolysed after 5 days at 50 oC.
Considered stable under environmental conditions.
Photolytic degradation of active substance and
metabolites above 10 % ‡
UV/ Vis spectra at pH 1.89, 7.01, and 11.23 indicate that
molar extinction coefficient for absorption at λ > 290 nm
is ≤ 2.1 mol-1. Indicates that photolytic degradation will
be minimal in the environment.
Literature review provided which indicated that
photolysis is not a significant route of degradation for 1decanol in water.
Quantum yield of direct phototransformation in
water at > 290 nm
Not submitted or required.
Readily biodegradable ‡
(yes/no)
No fully acceptable studies submitted. Therefore
considered not readily biodegradable, (though there
indications (in the literature review) that 1-decanol might
be readily biodegradable).
Degradation in water / sediment
No studies submitted and none required. Water, sediment and whole system DT 50 values of 5 days can be
assumed in FOCUS modelling as realistic worst case values on the basis of observed dissipation in aquatic
ecotoxicological studies and a literature review.
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PEC (surface water) and PEC sediment (Annex IIIA, point 9.2.3)
Data gap for surface water and sediment exposure concentrations.
Calculations following pertinent guidance cannot be completed while a valid soil DT50 is not available.
PEC (ground water) (Annex IIIA, point 9.2.1)
Data gap for groundwater exposure concentrations.
Calculations following pertinent guidance cannot be completed while a robust and valid soil degradation DT50
is not available.
Fate and behaviour in air (Annex IIA, point 7.2.2, Annex III, point 9.3)
Direct photolysis in air ‡
No data submitted and none required.
Quantum yield of direct phototransformation
No information submitted and none required
Photochemical oxidative degradation in air ‡
DT50 of 0.696 days (8.352 hours) hours derived by the
Atkinson model. 12 h OH radical concentration assumed
Volatilisation ‡
The vapour pressure of 1-decanol is 1.39 Pa at 25 oC and
Henry‟s Law constant of 22.99 Pa.m3.mol-1. Therefore
volatilisation of 1-decanol is expected to be high.
Metabolites
None
PEC (air)
Method of calculation
Expert judgement, based on vapour pressure,
dimensionless Henry's Law Constant and Atkinson Half
life.
PEC(a)
Maximum concentration
Expected to be negligible.
Residues requiring further assessment
Environmental occurring metabolite requiring
further assessment by other disciplines (toxicology
and ecotoxicology).
Soil: 1-decanol
Surface Water: 1-decanol
Sediment:1-decanol
Ground water: 1-decanol
Air: 1-decanol
Monitoring data, if available (Annex IIA, point 7.4)
Soil (indicate location and type of study)
Not available
Surface water (indicate location and type of study)
Not available
Ground water (indicate location and type of study)
Not available
Air (indicate location and type of study)
Not available
Points pertinent to the classification and proposed labelling with regard to fate and behaviour
data
Candidate for R53 – not readily biodegradable
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Ecotoxicology
Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)
Species
Test substance
Time scale
End point
End point
(mg/kg
bw/day)
(mg/kg feed)
Birds
Mallard duck
a.s.
Acute
>4640
Mallard duck
a.s.
Short-term
>2550.46
No study submitted
>10000
Long-term
Mammals
Rat
a.s.
Acute
No study submitted
4720
Long-term
Additional higher tier studies
No study submitted
Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Tobacco, two applications at 13.7 kg a.s./ha with a 10 day interval
Indicator species/Category
Time scale
ETE
TER
Annex VI Trigger
Tier 1 (Birds)
Insectivorous bird
Acute
740.90
>6.26
10
Insectivorous bird
Short-term
413.19
>6.17
10
Insectivorous birds
Long-term
Higher tier refinement (Birds)1
Extrapolated toxicity -8760
mg/kg bw
Extrapolated toxicity -4814
mg/kg bw/day
The risk was assessed low, due to the rapid metabolism
of fatty alcohols and 1-decanol by birds.
Acute
740.90
11.82
10
Short-term
413.19
11.65
10
Insectivorous mammal
Acute
120.83
39.06
10
Insectivorous mammal
Long-term
Tier 1 (Mammals)
The risk was assessed low, due to the rapid metabolism
of fatty alcohols and 1-decanol by mammals.
Higher tier refinement (Mammals)
None.
1
The risk assessment was refined by using the EFSA opinion paper “Risk assessment on birds and mammals” (EFSAQ2006-064, adopted on 17 June 2008). This gives a method to extrapolate an LD50 value upwards in cases where there is no
mortality or a single mortality at a limit dose in an acute avian toxicity study.
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Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Group
Test substance
Time-scale
End point
(Test type)
Toxicity1
(mg/L)
Laboratory tests
Fish
Pimephales promelas
1-decanol
Oncorhynchus mykiss
1-decanol
96 hr (flowthrough)
28 d (flowthrough)
Mortality, EC50
2.4(mm)
Growth NOEC
0.0064(mm)
48 h (semi
static)
21 d (semi
static)
Mortality, EC50
1.8(mm)
NOEC
0.51(mm)
72 h (static)
Yield: EyC50
1.57(mm)
Growth rate: ErC50
5.67(mm)
Yield: EyC50
0.73(mm)
Growth rate: ErC50
1.4(mm)
Fronds, ErC50
6.96(mm)
Fronds, EyC50
5.02(mm)
Aquatic invertebrate
Daphnia magna
1-decanol
Daphnia magna
1-decanol
Algae
Pseudokirchneriella
subcapitata
1-decanol
Navicula pelliculosa
1-decanol
72 h (static)
Higher plant
Lemna gibba
1-decanol
14 d (static)
Microcosm or mesocosm tests
Not required
1
All based on mean measured concentrations ( mm).
Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
No valid soil DT50 could be established and therefore the PECsw values calculated by the RMS were not correct.
However, it was noted that on the basis of this indicative PECsw values a high risk to aquatic organisms was
indicated since a 20 m no-spray buffer zone was not sufficient as risk mitigation.
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Bioconcentration
No data available.
Effects on honeybees (Annex IIA, point 8.3.1, Annex IIIA, point 10.4)
Test substance
Acute oral toxicity
(LD50 µg/bee)
Acute contact toxicity
(LD50 µg/bee)
a.s.
No data available - not
required
>13.8 µg/bee
Field or semi-field tests
Not required
Hazard quotients for honey bees (Annex IIIA, point 10.4)
Tobacco, 13.7 kg a.s./ha
Test substance
Route
Hazard quotient
Annex VI
Trigger
a.s.
Contact
<992.75
50
Effects on other arthropod species (Annex IIA, point 8.3.2, Annex IIIA, point 10.5)
Laboratory tests with standard sensitive species
Species
Test
substance
Test substrate
End point
Effect
(LR50 L product/ha)
Typhlodromus pyri
„AntakTM 79‟
Glass plate
LR50
2.62
Aphidius
rhopalosiphi
„AntakTM 79‟
Glass plate
LR50
0.621
Typhlodromus pyri
„AntakTM 79‟
Aphidius
rhopalosiphi
Chrysoperla
carnea
„AntakTM 79‟
Field treated bean
plants
Field treated bean
plants
Field treated bean
plants
„AntakTM 79‟
<50% effects
<50% effects
<50% effects
Day 0 = 20
Day 7 = 20
Day 0 >50% effects
Day 6 = 20
Day 0 = 20
Day 7 = 20
Tobacco, two applications of „AntakTM 79‟ at 20 L product/ha (13.7 kg a.s./ha) with a 10 day interval
1
Test substance
Species
„AntakTM 79‟
Typhlodromus pyri
„AntakTM 79‟
Aphidius rhopalosiphi
Effect
HQ in-field
HQ off-field1
Trigger
2.62
12.98
0.31
2
0.621
54.75
1.30
2
(LR50 g/ha)
Assuming 2.38% drift (1m with 2 applications)
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Further laboratory and extended laboratory studies
Species
Life
stage
Test substance,
substrate and
duration
Dose (kg
a.s./ha)
0
7+7 days
Typhlodromus
pyri
Aphidius
rhopalosiphi
Proto
nymphs
adult
Field treated bean
plants
Aged residue
7
48+24 hr
0
Field treated bean
plants
larvae
Field treated bean
plants
Aged residue
% adverse effect (ve mean positive
effect)
Mortality: 0
Reproductn: -63.3
Trigger
value
50 %
13.7
Mortality: 9.6
Reproductn: -26.8
Mortality: 87.5
Parasitism: na
50 %
50 %
13.7
Aged residue
Chrysoperla
carnea
Days
aged
6
0
Mortality: -2.6
Parasitism: 0.5
Mortality: -25.9
Reproductn: 8.0
50 %
50 %
13.7
7
Mortality:15.4
Reproductn: -3.4
50 %
Field or semi-field tests
Not required
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Effects on earthworms, other soil macro-organisms and soil micro-organisms (Annex IIA points
8.4 and 8.5. Annex IIIA, points, 10.6 and 10.7)
Test organism
Test substance
Time scale
End point
1-decanol
Acute 14 days
LC50 627.58 mg a.s./kg soil1
„AntakTM 79‟
Acute
LC50 657 mg a.s./kg dry soil1
Earthworms
Earthworms
Soil micro-organisms
Nitrogen mineralisation
a.s.
2.45% effect at day 28 at 54.8 mg
a.s./kg d.w.soil (mg a.s/ha)
Carbon mineralisation
a.s.
7.17% effect at day 28 at 54.8 mg
a.s./kg d.w.soil (mg a.s/ha)
Field studies
Not required
1
Correction not needed as study not conducted with high organic matter.
Toxicity/exposure ratios for soil organisms
Tobacco, two applications at 13.7 kg a.s./ha with a 10 day interval
Test organism
Test substance
Time scale
Soil PEC1 (mg
a.s./kg dw soil)
TER
Trigger
Acute
2.74
229
10
Acute
2.74
240
10
Earthworms
1
Earthworms
1-decanol
Earthworms
TM
„Antak
79‟
initial PEC from multiple applications
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Effects on non target plants (Annex IIA, point 8.6, Annex IIIA, point 10.8)
Preliminary screening data
Not required for herbicides as ER50 tests should be provided
Tobacco, 13.7 kg a.s./ha
Most
sensitive
species
Test
substance
ER50 (g/ha)2
vegetative
vigour
ER50 (g/ha)2
emergence
Exposure1
corn, onion,
sorghum,
wheat,
carrot,
cucumber,
lettuce,
radish,
soybean
and tomato
a.s.
≥11600 g
a.s./ha
(height and
weight)
≥11600 g
a.s./ha
379.49 (2.77% drift,
ESCORT 2 and
SANCO/10329/2002 rev
2 final – Royaltac®)
(g/ha)
TER
Trigger
29.14
5
2
Additional studies (e.g. semi-field or field studies)
Not required
Effects on biological methods for sewage treatment (Annex IIA 8.7)
Test type/organism
End point
Activated sludge and other microbial strains
No respiration inhibition at the PECsw
Ecotoxicologically relevant compounds (consider parent and all relevant metabolites requiring
further assessment from the fate section)
Compartment
soil
Parent
water
Parent
sediment
Parent
groundwater
Parent
Classification and proposed labelling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/peer review proposal
Active substance
R50: Very toxic to aquatic organisms
R53: May cause long-term adverse effects in the aquatic
environment
On the basis of the above R phrases, the „N‟ symbol and
„Dangerous for the environment‟ are proposed.
RMS/peer review proposal
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Preparation
R50: Very toxic to aquatic organisms
R53: May cause long-term adverse effects in the aquatic
environment
Current guidance suggests the following S phrases:
S35: „This material and its container must be disposed of
in a safe way‟
and
S57: „Use appropriate containment to avoid
environmental contamination‟
The label should also contain the following Annex V SP
1 phrase:
Do not contaminate water with the product or its
container. Do not clean application equipment near
surface water. Avoid contamination via drains from
farmyards and roads.
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APPENDIX B – USED COMPOUND CODE(S)
Code/Trivial name
Chemical name
Structural formula
none
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ABBREVIATIONS
1/n
°C
µg
µm
a.s.
AChE
ADE
ADI
AF
AOEL
AP
AR
ARfD
AST
AV
BCF
BUN
bw
CA
CAS
CFU
ChE
CI
CIPAC
CL
d
DAA
DAR
DAT
DM
DT50
DT90
dw
EbC50
EC
EC50
ECHA
EEC
EINECS
ELINCS
EMDI
ER50
ErC50
EU
EUROPOEM
f(twa)
FAO
FIR
FOB
FOCUS
g
GAP
slope of Freundlich isotherm
decadic molar extinction coefficient
degree Celsius (centigrade)
microgram
micrometer (micron)
active substance
acetylcholinesterase
actual dermal exposure
acceptable daily intake
assessment factor
acceptable operator exposure level
alkaline phosphatase
applied radioactivity
acute reference dose
aspartate aminotransferase (SGOT)
avoidance factor
bioconcentration factor
blood urea nitrogen
body weight
Chemical Abstracts Service name
Chemical Abstract Service
colony forming units
cholinesterase
confidence interval
Collaborative International Pesticide Analytical Council Limited
confidence limits
day
days after application
draft assessment report
days after treatment
dry matter
period required for 50 percent disappearance (define method of estimation)
period required for 90 percent disappearance (define method of estimation)
dry weight
effective concentration (biomass)
emulsifiable concentrate
effective concentration
European Chemical Agency
European Economic Community
European Inventory of Existing Commercial Chemical Substances
European List of New Chemical Substances
estimated maximum daily intake
emergence rate/effective rate, median
effective concentration (growth rate)
European Union
European Predictive Operator Exposure Model
time weighted average factor
Food and Agriculture Organisation of the United Nations
Food intake rate
functional observation battery
Forum for the Co-ordination of Pesticide Fate Models and their Use
gram
good agricultural practice
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GC
GCPF
GGT
GM
GS
GSH
h
ha
Hb
Hct
hL
HPLC
HPLC-MS
HQ
IEDI
IESTI
ISO
IUPAC
JMPR
Kdoc
kg
KFoc
L
LC
LC50
LC-MS
LC-MS-MS
LD50
LDH
LOAEL
LOD
LOQ
m
M/L
MAF
MCH
MCHC
MCV
mg
mL
mm
MRL
MS
MSDS
MTD
MWHC
NESTI
ng
NOAEC
NOAEL
NOEC
NOEL
gas chromatography
Global Crop Protection Federation (formerly known as GIFAP)
gamma glutamyl transferase
geometric mean
growth stage
glutathion
hour(s)
hectare
haemoglobin
haematocrit
hectolitre
high pressure liquid chromatography
or high performance liquid chromatography
high pressure liquid chromatography – mass spectrometry
hazard quotient
international estimated daily intake
international estimated short-term intake
International Organisation for Standardisation
International Union of Pure and Applied Chemistry
Joint Meeting on the FAO Panel of Experts on Pesticide Residues in Food and
the Environment and the WHO Expert Group on Pesticide Residues (Joint
Meeting on Pesticide Residues)
organic carbon linear adsorption coefficient
kilogram
Freundlich organic carbon adsorption coefficient
litre
liquid chromatography
lethal concentration, median
liquid chromatography-mass spectrometry
liquid chromatography with tandem mass spectrometry
lethal dose, median; dosis letalis media
lactate dehydrogenase
lowest observable adverse effect level
limit of detection
limit of quantification (determination)
metre
mixing and loading
multiple application factor
mean corpuscular haemoglobin
mean corpuscular haemoglobin concentration
mean corpuscular volume
milligram
millilitre
millimetre
maximum residue limit or level
mass spectrometry
material safety data sheet
maximum tolerated dose
maximum water holding capacity
national estimated short-term intake
nanogram
no observed adverse effect concentration
no observed adverse effect level
no observed effect concentration
no observed effect level
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OM
Pa
PD
PEC
PECair
PECgw
PECsed
PECsoil
PECsw
pH
PHED
PHI
PIE
pKa
POEM
Pow
PPE
ppm
ppp
PT
PTT
QSAR
r2
RMS
RPE
RUD
SC
SD
SFO
SSD
STMR
t1/2
TER
TERA
TERLT
TERST
TK
TLV
TMDI
TRR
TSH
TWA
UDS
UV
W/S
w/v
w/w
WBC
WG
WHO
wk
yr
organic matter content
Pascal
proportion of different food types
predicted environmental concentration
predicted environmental concentration in air
predicted environmental concentration in ground water
predicted environmental concentration in sediment
predicted environmental concentration in soil
predicted environmental concentration in surface water
pH-value
pesticide handler's exposure data
pre-harvest interval
potential inhalation exposure
negative logarithm (to the base 10) of the dissociation constant
Predictive Operator Exposure Model
partition coefficient between n-octanol and water
personal protective equipment
parts per million (10-6)
plant protection product
proportion of diet obtained in the treated area
partial thromboplastin time
quantitative structure-activity relationship
coefficient of determination
rapporteur Member State
respiratory protective equipment
residue per unit dose
suspension concentrate
standard deviation
single first-order
species sensitivity distribution
supervised trials median residue
half-life (define method of estimation)
toxicity exposure ratio
toxicity exposure ratio for acute exposure
toxicity exposure ratio following chronic exposure
toxicity exposure ratio following repeated exposure
technical concentrate
threshold limit value
theoretical maximum daily intake
total radioactive residue
thyroid stimulating hormone (thyrotropin)
time weighted average
unscheduled DNA synthesis
ultraviolet
water/sediment
weight per volume
weight per weight
white blood cell
water dispersible granule
World Health Organisation
week
year
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