2,2'-azobis[4-methoxy-2,4-dimethylvaleronitrile]

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Type of information:

experimental study planned

Study period:

as soon as ECHA decission is available

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS
[Please provide information for all of the points below. The information should be specific to the endpoint for which testing is proposed. Note that for testing proposals addressing testing on vertebrate animals under the REACH Regulation this document will be published on the ECHA website along with the third party consultation on the testing proposal(s).]

NON-CONFIDENTIAL NAME OF SUBSTANCE:
2,2’-Azobis (4-Methoxy-2,4-Dimethyl Valeronitrile)

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: no GLP studies present to current knowledge
- Available non-GLP studies: no non-GLP studies present to current knowledge
- Historical human data: no historical human data present to current knowledge
- (Q)SAR: no QSAR models available to provide sufficiently detailed information
- In vitro methods: presented in vitro methods not sufficient to conclude on hazard,
according to ITS presented in Guidance on information requirements and chemical safety assessment, Chapter R.7a: Endpoint specific guidance Version 6.0 – July 2017, further in vitro testing is not foreseen.
- Weight of evidence: no further data available to allow weight of evidence
- Grouping and read-across: no substances identified to qualify for read-across and grouping. Similar substances (based on main chemical functional group) are available but show variable physico-chemical properties and therefore do not qualify for Read across.
- Substance-tailored exposure driven testing [if applicable]: not applicable
- Approaches in addition to above [if applicable]: not applicable
- Other reasons [if applicable] The presented in vitro test data is conclusive but not sufficient according to (EC) No 2006/1907 Annex VII Column 2 and Annex VIII Column 2 to fulfill the information requirement.

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- specific adaption possibilities not available for this endpoint

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed:
Based on the findings in the in vitro tests performed, a gene mutation mechanism may be excluded.
A positive result for the in vitro chromosome aberration assay was obtained. Therefore an in vivo cytogenicity or micronucleus test is considered.
According to Guidance on information requirements and chemical safety assessment, Chapter R.7a: Endpoint specific guidance Version 6.0 – July 2017,
a study according to OECD 474 has the potential to detect both clastogenic and aneugenic substances and is therefore chosen over a study according to OECD 475.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Type of assay:

other: mammalian cell Micronucleus test

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-azobis[4-methoxy-2,4-dimethylvaleronitrile]

EC Number:

239-593-8

EC Name:

2,2'-azobis[4-methoxy-2,4-dimethylvaleronitrile]

Cas Number:

15545-97-8

Molecular formula:

C16H28N4O2

IUPAC Name:

2,2'-azobis[4-methoxy-2,4-dimethylvaleronitrile]