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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
Reference substance name:
Disodium 4-[4-[[5-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]-2,5-dichlorobenzenesulphonate
EC Number:
274-499-0
EC Name:
Disodium 4-[4-[[5-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]-2,5-dichlorobenzenesulphonate
Cas Number:
70247-70-0
Molecular formula:
C19H14BrCl2N5O8S2.2Na
IUPAC Name:
disodium 4-[4-({5-[(2-bromoacryloyl)amino]-2-sulfonatophenyl}diazenyl)-3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl]-2,5-dichlorobenzenesulfonate
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.