Send Enquiry
News Coverage
 

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

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*

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