Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Type of information:
experimental study planned
Justification for type of information:
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Reaction mass of disodium (sulphonatothio)acetate and sodium chloride

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: No adequate and reliable GLP studies addressing genetic toxicity in vivo are available with the test substance itself or similar substances defined according to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No. 1907/2006.
- Available non-GLP studies: No adequate and reliable non-GLP studies addressing genetic toxicity in vivo are available with the test substance or similar substances.
- Historical human data: not available
- (Q)SAR: Q(SAR) methods are not applicable to assess the full scope of genetic toxicity
- In vitro methods: Validated in vitro methods to assess genetic toxicity are available so far. However, appropriate in vivo mutagenicity studies shall be considered in case of a positive result in any of the genotoxicity in vitro studies.
- Weight of evidence: In general, information (QSAR, in vitro data) can be considered which is suitable to assess genetic toxicity in a weight of evidence approach unless these data demonstrate clear results.
- Grouping and read-across: not 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:
In accordance with Regulation (EC) No. 1272/2008, Annex VIII, 8.4, Column 2, appropriate in vivo mutagenicity studies shall be considered in case of a positive result in any of the genotoxicity studies in Annex VII or VIII. In order to further assess the positive result in the in vitro cytogenicity / chromosome aberration study in mammalian cells (BASF SE, 1996), a GLP-compliant in vivo Mammalian Erythrocyte Micronucleus Test in the rat via the oral route following OECD 474 is proposed, according to Annex VIII, Column II, 8.4.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION: none

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