Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Type of information:
experimental study planned
Study period:
6 months after ECHA's final decision
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
Hazard endpoint for which vertebrate testing was proposed: Genetic toxicity in vivo with the registered substance.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Reactive Red 65

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: There are no available GLP studies on the substance or on read-across analogues suitable to fill the endpoint.

- Available non-GLP studies: There are no available non-GLP studies on the substance or on read-across analogues suitable to fill the endpoint.

- Historical human data: There is no historical human data on the substance or on read-across analogues suitable to fill the endpoint.

- (Q)SAR: (Q)SAR analysis is not sufficient to fill the endpoint. There are no adequate models to address this endpoint.

- In vitro methods: Already available, but further in vivo data needed. Available study: OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

- Weight of evidence: There is not sufficient data on the substance or read across analogues to be able to establish a weight of evidence argument.

- Grouping and read-across: There is not sufficient data on the substance or read-across analogues to be able to group or propose read-across.

- Substance-tailored exposure driven testing [if applicable]: Not applicable
- Approaches in addition to above [if applicable]: Not applicable
- Other reasons [if applicable]: 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:
- Test proposal is fully in line with ECHA guidance document*, and can neither be replaced by in vitro testing nor by using other data from other substances.
* Chapter R.7a: Endpoint specific guidance Version 4.1 – October 2015

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: OECD Guideline 474: Mammalian Erythrocyte Micronucleus Test

Data source

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Applicant's summary and conclusion

Executive summary:

The Registrant proposes to conduct the following test by oral route using the indicated test method:

EU Method B.12 Mutagenicity -In Vivo Mammalian Erythrocyte Micronucleus test or the equivalent OECD Guideline 474 – Mammalian Erythrocyte Micronucleus test

The Registrant has assessed genotoxicity of FAT 40062/B TE in three in vitro systems.

In Reverse Mutation Assay using Bacteria (Salmonella Typhimurium) FAT 40062/B exerted a mutagenic effect in this test system.

In vitro Mammalian Chromosome Aberration Test, FAT 40062/B TE induced structural chromosome aberrations in the V79 Chinese hamster cell line in the absence and the presence of metabolic activation.

In vitro Mammalian Cell Gene Mutation Test (HPRT-Locus) in Chinese Hamster V79 Cells, FAT 40062/B TE and its metabolites did not show any mutagenic activity in this forward mutation system.

According to REACH Annex IX 8.4 Column 2, if there is a positive result in any of the in vitro genotoxicity studies in Annex VII or VIII and there are no results available from an in vivo study already, an appropriate in vivo somatic cell genotoxicity study shall be proposed by the Registrant. The information on this endpoint is not available for the registered substance but needs to be present in the technical dossier to meet the data requirements. Consequently, there is a data gap and it is necessary to generate the data for this endpoint.