|
CIBRC (CENTRAL INSECTICIDES BOARD AND REGISTRATION COMMITTEE) CHECK
LISTS OF THE REQUIREMENT OF TOXICITY STUDIES FOR SUBMISSION OF APPLICATIONS FOR THE GRANT OF REGISTRATION OF PESTICIDES, UNDER THE INSECTICIDES ACT-1968
( Updated on 04-02-2013)
DATA REQUIREMENT OF TOXICITY FOR
REGISTRATION OF PESTICIDES (OTHER THAN HERBICIDES)
UNDER SECTION 9(3)/ 9(3B) - as on 05-10-2011
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Abbreviations :
|
|
R
|
:
|
Required
|
NR
|
:
|
Not Required
|
|
TIM
|
:
|
Technical Indigenous
Manufacture
|
TI
|
:
|
Technical Import
|
|
FI
|
:
|
Formulation Import
|
FIM
|
:
|
Formulation Indigenous
Manufacture
|
|
IM
|
:
|
Indigenous Manufacture
|
NF
|
:
|
New Formulation
|
|
CBN
|
:
|
Combination
|
AR
|
|
Already Registered
|
|
Sl. No.
|
Parameter
|
9(3B)
|
9(3)
|
9(4)
|
|
|
|
TI
|
TIM
|
FIM
|
TI
|
TIM
|
FI
|
FIM
|
TI Vs TIM
|
TIM Vs TI
|
TI (New
Source)
|
NF**(IM)
|
TIM* (AR) Vs TI
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
11
|
12
|
13
|
14
|
|
C.
|
TOXICITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1.
|
Acute oral in rat & mice
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|
2
|
Acute dermal
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|
3
|
Acute inhalation
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
NR
|
|
4
|
Primary skin irritation
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|
5
|
Irritation to mucous membrane
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
6
|
Sub-acute oral rat
|
R
|
R
|
NR/R
|
R
|
R
|
NR/R
|
NR/R
|
NR
|
NR
|
R
|
NR/R
|
NR
|
7
|
Sub-acute oral dog
|
R*
|
R*
|
NR/R*
|
R*
|
R*
|
NR/
R*
|
NR/
R*
|
NR
|
NR
|
R*
|
NR/
R*
|
NR
|
|
8.
|
Sub-acute dermal
|
R
|
R
|
NR/R
|
R
|
R
|
NR/R
|
NR/R
|
NR
|
NR
|
R
|
NR/R
|
NR
|
|
9.
|
Sub-acute inhalation
|
R
|
R
|
NR/R
|
R
|
R
|
NR/R
|
NR/R
|
NR
|
NR
|
R
|
NR/R
|
NR
|
|
10.
|
Neuro-toxicity
|
NR
|
NR
|
NR
|
R
|
R
|
NR/R
|
NR/R
|
NR
|
NR
|
NR
|
NR/R
|
NR
|
|
11.
|
Synergism & potentiation
|
NR
|
NR
|
NR
|
R
|
R
|
NR/R
|
NR/R
|
NR
|
NR
|
NR
|
NR
|
NR
|
|
12.
|
Teratogenicity
|
NR
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
|
13.
|
Effect on reproduction
|
NR
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
|
14.
|
Carcinogenicity
|
NR
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
|
15.
|
Metabolism
|
NR
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
|
16.
|
Mutagenicity
|
NR
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR/R
|
NR/R
|
R
|
NR
|
NR
|
|
17.
|
Toxicity to birds (two)
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
NR
|
NR
|
R
|
NR
|
NR
|
|
18.
|
Toxicity to fish (Fresh water)
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
NR
|
NR
|
R
|
NR
|
NR
|
|
19.
|
Toxicity to honeybees
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
NR
|
NR
|
R
|
NR
|
NR
|
|
20.
|
Toxicity to live stock
|
R
|
R
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
NR
|
R
|
NR
|
NR
|
|
21.
|
Medical data
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
NR
|
R
|
|
22.
|
Human toxicity information from foreign countries
|
R
|
R
|
R
|
R
|
NR
|
NR
|
NR
|
NR
|
NR
|
R
|
NR
|
NR
|
|
23.
|
Observation in man (Health records of spray operators)
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR^^
|
NR^^
|
NR
|
NR
|
NR
|
NR^^
|
NR
|
|
24.
|
Health records of Industrial workers.
|
NR
|
NR
|
NR
|
R
|
NR
|
R
|
NR
|
R
|
NR
|
R
|
NR
|
NR
|
|
25.
|
Toxicity to live stock (Field trial & observation)
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR^^
|
NR^^
|
NR
|
NR
|
NR
|
NR
|
NR
|
|
26.
|
International report on carcinogenicity & genotoxicity
status
|
NR
|
NR
|
NR
|
R/NR
|
R/NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
|
|
NR^^: Not required as per decision of 318th
RC held on 27-04-2011
NF** :
In case of wettable powder, if toxicological data is generated for EC
formulation applicable as per guidelines, then there is no need to generate
data on wettable powder contRning the same a.i.
TIM*(AR)
Vs TI U/s 9(4): If chemical equivalence fRls in the sample
submitted by the applicant / in-process samples, required to submit data on
toxicity as per the guidelines for TIM vs TI U/s 9(3)
R*: Any peer reviewed published data/information
shall be acceptable (approved in 343rd and 344th RC Meeting)
|
TOXICOLOGICAL DATA REQUIREMENTS FOR REGISTRATION OF ANTAGONISTIC FUNGI UNDER SECTION 9(3B)
and 9(3) OF THE INSECTICIDE ACT, 1968
|
For mother culture
1. Single
Dose Oral (rat and mouse)
2. Single
dose pulmonary
3. Single
dose Dermal
4. Single
dose intraperitoneal
5. Human
safety records.
|
For formulation
1. Data
on mother culture
2. Single
Dose Oral (Rat & Mouse)
3. Single
dose pulmonary
4. Primary
skin irritation
5. Primary
eye irritation
6. Human
safety records
|
|
For
formulated product to be directly manufactured:
(Mammalian toxicity testing of formulations)
1.
Single dose oral (Rat & Mouse),
Toxicity/Infectivity/Pathogenicity
2.
Single dose pulmonary
Toxicity/Infectivity/Pathogenicity
(Intratracheal
preferred)
3.
Single dose dermal
Infectivity
4.
Single dose intraperitoneal (Infectivity)
5.
Primary skin
irritation
6.
Primary eye irritation
|
Environmental
safety testing: Core Information requirements (For formulation
only)
Non-target
Vertebrates
1.
Mammalsa
2.
Birds(two species)b
3.
Fresh water fishc
Non-target
invertebrates
1.
Soil
invertebratesd
|
Data
requirements for registration of Entomotoxic bacteria technical and formulation
under Section 9 (3B) and 9 (3) of the Insecticide Act, 1968
|
Parameter
|
Technical
|
Formulation
|
|
9(3B)
|
9(3)
|
9(3B)
|
9(3)
|
|
Single
exposure studies
|
R
|
R
|
R
|
R
|
|
Oral toxicity / pathogenicity
|
R
|
R
|
R
|
R
|
|
Dermal toxicity / pathogenicity
|
R
|
R
|
R
|
R
|
|
Inhalation toxicity / pathogenicity
|
R
|
R
|
R
|
R
|
|
Primary skin irritation
|
R
|
R
|
R
|
R
|
|
Mucous membrane irritation
|
R
|
R
|
R
|
R
|
|
Allergy / sensitization / immuno supression
|
R
|
R
|
R
|
R
|
|
Eco-toxicity
|
|
|
|
|
|
Toxicity to birdsa
|
NR
|
NR
|
NR
|
R
|
|
Toxicity to fishb
|
NR
|
NR
|
NR
|
R
|
|
Toxicity to honeybees
|
NR
|
NR
|
NR
|
R
|
|
Toxicity to silkworm
|
NR
|
NR
|
NR
|
R
|
Data requirements for Registration of
Pesticides Exclusively for Export
Categories
of Pesticides for Export Registration
Category – I
Import and
indigenous manufacture of technical grade pesticides (not registered for
manufacture and use in the country ) for export only. (In case of registered pesticides, import
from approved source only.)
Category-II
Registration of
indigenous manufacture of pesticides formulations based on technical grade
pesticides not registered for use in the country. ( in case of formulation export, separate application for import / manufacture
of technical grade pesticide is required to be submitted).
Category-III
Indigenous
manufacture of pesticides (technical grade and their formulations) already
registered for use in the country with same or different impurity profile / different adjuvant with same, lower
or higher concentration and new types of formulations for export only. ( In
case of registered pesticides, import
from approved source only ).
Category-IV
New
combination of pesticidal formulations.
( In case of new
unregistered constituents, separate application is required to be submitted).
Category-V
Botanical
pesticides including need based pesticides / Bt. / Bs. / NPV / GV / Antagonistic
fungi etc.
Category
– VI
Import of new
formulation of pesticides ( not registered for manufacture and used in the
country ) for export only. ( In
case of registered pesticides, import
from approved source of technical only ).
|
Sl. No.
|
Parameter
|
CATEGORY
|
|
|
|
I
|
II
|
III
|
IV
|
V
|
VI***
|
|
1.
|
Acute
Oral rat
|
R*
|
R*
|
NR*
|
R*
|
R*
|
R*
|
|
2.
|
Acute
dermal
|
R*
|
R*
|
NR*
|
R*
|
R*
|
|
|
3.
|
Acute
inhalation
|
R*
|
R*
|
NR*
|
R*
|
NR*
|
R*
|
|
4.
|
Primary
skin irritation
|
R*
|
R*
|
NR*
|
R*
|
R*
|
R*
|
|
5.
|
Irritation
to mucous membrane
|
R*
|
R*
|
NR*
|
R*
|
R*
|
R*
|
|
6.
|
Effect on
reproduction
|
R**
|
NR
|
NR
|
NR
|
R**
|
R**/NR
|
|
7.
|
Carcinogenicity
|
R**
|
NR
|
NR
|
NR
|
R**
|
R**/NR
|
|
8.
|
Mutagenicity
|
R**
|
NR
|
NR
|
NR
|
R**
|
R**/NR
|
|
9.
|
Neuro
toxicity****
|
NR
|
NR
|
NR
|
NR
|
R**
|
R**/NR
|
|
10.
|
Sign and
symptoms of poisoning & treatment
|
R
|
R
|
R
|
R
|
R
|
R
|
* Published information on LD 50 / LC 50
/ irritation index (moderate / severe / mild
/ none ) score value. Alternatively same
information as per studies undertaking
according to the guidelines of OECD, EPA or the importing country / as per existing guidelines of
Registration Committee. ** Information on these parameters shall be
acceptable from any of the following sources: i) From the reviews undertaken by
International organizations / institutions like WHO, joint bodies of FAO / WHO,
International Registry for Potential Toxic Chemicals (IRPTC), International
Agency on Research on Cancer (IARC), etc. ii)
Authenticated information from the
Laboratory/Institute which would have undertaken these studies. iii)
Authentic information on these
parameters from any National Pesticide Registration Authority. iv)
Information supported with published
research studies / evaluation v)
Information with relevant details on
these parameters could be considered if secured through Internet or Medline
search. vi)
Information on neurotoxicity for biopesticdide / concentrate and need based
technical are required.. *** Information is required for technical also. **** Information on neurotoxicity
is required for OP, carbamate & neem based pesticides
|
S.No.
|
Toxicity data / information
|
Category V
Bt. & Bs based pesticides
|
|
|
|
Technical
|
Formulation
|
|
A
|
Single
Exposure studies
|
|
|
|
1.
|
Oral
toxicity / Pathogenecity
|
R
|
R
|
|
2.
|
Dermal
toxicity / Pathogenicity
|
R
|
R
|
|
3.
|
Mucous
membrane irritation
|
R
|
R
|
|
4.
|
Primary
skin irritation
|
R
|
R
|
|
5.
|
Inhalation
toxicity / Pathogenecity
|
R
|
R
|
|
6.
|
Allergy /
Sensitization
|
R
|
R
|
Note: Allergy test has to be conducted as per
Standard Protocol prescribed by BIS
|
