Registration Dossier

Administrative data

Endpoint:
fish, juvenile growth test
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
- The test item had significant toxic effects on fish. The 96-h LC50 value was determined to be 1.32 mg/l. Therefore, it is suggested to conduct a long-term toxicity study on the same species.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: 4,4'-Methylenebis(2,6-diethylaniline) / CAS 13680-35-8 / EC 237-185-4

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies: acute toxicity on fish (LC50: 1.2 mg/L), acute toxicity on Daphnia Magna and algal growth inhibition test (no effects at stauration concentration)
- Available non-GLP studies: none
- Historical human data: none
- (Q)SAR: none
- In vitro methods: none
- Weight of evidence: none
- Grouping and read-across: not applicable
- Substance-tailored exposure driven testing [if applicable]: not applicable
- Approaches in addition to above [if applicable]: not applicable

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: exact study design needs to be discussed

Data source

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method C.14 (Fish Juvenile Growth Test)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 215 (Fish, Juvenile Growth Test)
Deviations:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Physical state: see above
- Appearance: see above

Results and discussion

Applicant's summary and conclusion