Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
genetic toxicity in vivo, other
Remarks:
Method/Guideline has to be chosen once all information are available
Type of information:
experimental study planned
Study period:
The study will be initiated once Decision from ECHA is received.
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:
- Name of the substance on which testing is proposed to be carried out : Dimethyl 2,2'-azobis(2-methylpropionate)
- Name of the substance for which the testing proposal will be used [if different from tested substance]

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 : none available
- Available non-GLP studies : none available
- Historical human data : none available
- (Q)SAR : available but not sufficient to fulfill data requirement
- In vitro methods: available but not sufficient to fulfill data requirement
- Weight of evidence : not possible due to lack of information
- Grouping and read-across : assessed and found to be not sufficient to fulfill data requirement
- Substance-tailored exposure driven testing [if applicable] not applicable
- Approaches in addition to above [if applicable] not applicable
- Other reasons [if applicable]

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:
- the necessity for this study proposal is based on column 2 of Annex VIII

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]:
toxicological studies are still on going and a decission on the final study design can be made once all results from on-going studies are available.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Results and discussion

Applicant's summary and conclusion

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