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:
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: Sodium 1-hydroxyethanesulphonate


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: A set of 3 GLP studies according to the current OECD TGs is available for the substance (see IUCLID chapter 7.6.1): Ames test (40M0540/16M386, 2017), mammalian cell mutagenicity test (50M0540/16X362, 2017), micronucleus test (31M0540/16X361, 2017).
- Available non-GLP studies: none
- Historical human data: none
- (Q)SAR: not applicable
- In vitro methods: see "available GLP studies"
- Weight of evidence: not applicable
- 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:
- Annexes VI to X (and column 2 thereof) do not provide a possibility to waive an in vivo genotoxicity test when positive in vitro findings are available. On the contrary, section 8.4 in Annex VIII, column 2, states that "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."

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: A standard OECD 474 TG study is proposed

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