Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study planned
Study period:
After approval by ECHA
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:
- Potassium dicyanoaurate

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 negative Ames test of reverse mutation in bacterial cells and a positive in vitro micronucleus test in cultured human lymphocytes
- Available non-GLP studies: None available
- Historical human data: None available
- (Q)SAR:No data
- In vitro methods: See available GLP studies
- Weight of evidence: The positive in vitro micronucleus test triggers the conduct of the in vivo test in accordance with requirements in Annex IX
- Grouping and read-across: Not appropriate
- Substance-tailored exposure driven testing [if applicable]
- Approaches in addition to above [if 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:
- A positive result was obtained in the Annex VIII in vitro micronucleus study using cultured human lymphocytes. In accordance with Column 2 rules (Section 8.4) an appropriate in vivo mutagenicity study should be considered in the event of such a positive result. In this case, the appropriate in vivo somatic cell genotoxicity study proposed under Annex IX would be the OECD474 guideline study, Mammalian Erythrocyte Micronucleus Test conducted in rats or mice. This assay is considered useful for further investigation of a mutagenic effect detected in the in vitro system since it allows consideration of factors of in vivo metabolism, pharmacokinetics and DNA repair processes.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: In accordance with the OECD test guideline 474

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Applicant's summary and conclusion