Guidelines for registration of insecticidal formulations for use in
aircraft disinsection.
1.
2.
General requirement
All insecticides for aircraft disinsection must be manufactured only from the
technical grade insecticides which are registered under the Insecticides Act, 1968
Data on insecticides formulation shall be considered along with the data on
technical grade insecticides and not in isolation.
Data requirement from Chemistry parameters
The common name of the aircraft disinsection insecticides which is to be printed
on the labels and leaflets should be written as aircraft disinsection insecticide
containing ‘X’……. %w/w and ’Z’…………%w/w etc.
1.
Chemical composition and allied data requirement
1.1
Source of supply of the technical grade material with minimum purity to be used
in the formulation should be given.
2.
Chemical composition
2.1
Complete chemical composition of the formulation should be submitted.
2.
Complete data on the identity and physico-chemical characters of various
ingredients of the formulation should be submitted.
2.3
The chemical composition for the formulation should include the kind, name and
percentage of all the ingredients that is to be used in the formulation.
2.4
“The number of active ingredients in the aircraft disinsection combination
product should not be more than two. However, if any applicant is able to submit
satisfactory method of analysis for more than two active ingredients in the
combination product, the Committee may consider such request on its merit”.
Specification
Wherever no specifications are available, the Registration Secretariat may
harmonize specification evolving its own procedure.
Analytical Test Report
The analytical test report giving the analysis of a particular batch of all the
parameters included in the specifications shall be submitted from an independent
reputed National/International laboratory.
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Shelf life data
The expected shelf life claim for the product along with the supporting data be
submitted. This data should confirm to the guidelines prescribed by the Central
Insecticides Board.
Method of analysis
Wherever available, an BIS method for analysis is followed.
The methods for the analysis of various active ingredients used in a formulation
be provided. As far as possible, single, multiple insecticides analysis method be
suggested.
For identification of active ingredient in the formulation, suitable qualitative
methods may be developed and provided followed by detailed analysis as for
quantification as stated above.
i
Bioefficacy claims to be given on the labels
A brief direction concerning the major usage of the insecticide should be given
on the labels.
ii
Wherever the Registration Committee has approved the product for restricted
use, this should be indicated very clearly on the labels in capital letters. ‘For
_____________ use only”
iii
Instructions regarding insecticide ‘Note to be used on any food as well as crops
to be given’.
i
Bioefficacy claims to be given on the leaflets
Detailed information on the usage of insecticide indicating the names of insects,
method of application, dosage, places of treatments, appliances to be used etc.
should be given in paragraph forms. Common name of the insects should be
given.
ii
Wherever the Registration Committee has approved the product for restricted
use, this fact should be indicated very clearly on the leaflets in bold letters.
iii
Instructions regarding insecticide ‘Not to be used on any food crop to be given’
i
ii
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Bioefficacy and residue data
Bioefficacy test on the proposed formulation should be conducted in Indian
conditions minimum 2 trials in each of 3 National Laboratories / NABL
accredited laboratories, recognized by Government of India.
Data on persistence of pesticides on commonly used surfaces in the aircrafts and
concentration in air, as applicable, should be generated in three National
Laboratories/ NABL accredited laboratories.
1
Toxicology
Acute oral rat and mice
2.
Acute dermal
3.
Acute inhalation
4.
Primary skin irritation
5.
Irritation to mucous membrane
6.
Health monitoring studies on spraymen and/or volunteers on board as per the
protocol to be approved by the Registration Committee.
A
Packaging and labeling
Type of packaging
1.
Specification of primary packaging system.
2.
Specification of secondary packaging system.
3.
Specification of transport packaging system.
B
Manner of packing
Detailed information with reference to method by which inner most pack shall be
further packed in secondary and transport packing.
C
Container content compatibility study
As per relevant B.I.S. method
D
Manner of labeling
Method of labeling as per requirements of Insecticides Rule, 1971 along with
direction of use.
E
Labels and leaflets
7 copies of labels and leaflets as per requirements of Insecticides Rule, 1971 for
1.
Small size packing upto 250ml capacity and below
2.
Large size packing upto 500ml capacity and above.
Note: The above guidelines are for registration of those insecticidal formulations
whose technical grade material is registered u/s 9(3) of the Insecticides Act,
1968.
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