Registration Dossier

Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study planned
Study period:
subject to ECHA approval
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Reactive Yellow 39 (EC# 274-499-0)

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 : 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 readacross 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 : There are no adequate models to address this end point.
- In vitro methods : Already available, but further in vivo data needed.
- 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.

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 486: Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo.
Guideline: OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo) in vivo mammalian cell study: DNA damage and/or repair

Data source

Materials and methods

Type of assay:
unscheduled DNA synthesis

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Solid
Details on test material:
None

Results and discussion

Applicant's summary and conclusion

Executive summary:

Testing proposal for in vivo Genetic toxicity as per OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo) in vivo mammalian cell study: DNA damage and/or repair.