Registration Dossier
Registration Dossier
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EC number: 237-185-4 | CAS number: 13680-35-8
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study planned
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
- An existing MNT in-vitro study does not allow a final assessment of this endpoint due to quality reasons (Klimisch 4). Therefore, it is suggested to perform an in-vivo MNT acc. OECD 474
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: Ames test (non-mutagenic), chromosome aberration in-vitro (non-clastogenic), gene mutation in-vitro (HPRT/non-mutagenic), MNT in-vitro (inconclusive)
- Available non-GLP studies: none
- Historical human data: none
- (Q)SAR: none
- In vitro methods: MNT in-vitro showed an inconclusive result
- 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]: OECD 474
Data source
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4,4'-methylenebis[2,6-diethylaniline]
- EC Number:
- 237-185-4
- EC Name:
- 4,4'-methylenebis[2,6-diethylaniline]
- Cas Number:
- 13680-35-8
- Molecular formula:
- C21H30N2
- IUPAC Name:
- 4,4'-methylenebis(2,6-diethylaniline)
- Test material form:
- solid: crystalline
- Details on test material:
- - Physical state: see above
- Appearance: see above
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
Results and discussion
Applicant's summary and conclusion
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