Disodium 6-amino-5-[[4-[(2-bromo-1-oxoallyl)amino]-2-[(4-methyl-3-sulphonatophenyl)sulphonyl]phenyl]azo]naphthalene-2-sulphonate

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian cell study: DNA damage and/or repair

Type of information:

experimental study planned

Study period:

Subject to ECHA approval

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 084 (EC# 286-122-7).
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 end point.
- In vitro methods: Already available, but further in vivo data needed. Available studies: 1. Study with methodology equivalent to OECD Guideline 471 (Bacterial Reverse Mutation Assay); 2. In vitro Mammalian Chromosomal Aberration Test conducted according to OECD Guideline 473
- 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 489: In Vivo Mammalian Alkaline Comet Assay.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)

Test material

Test material information

1

Reference substance name:

Disodium 6-amino-5-[[4-[(2-bromo-1-oxoallyl)amino]-2-[(4-methyl-3-sulphonatophenyl)sulphonyl]phenyl]azo]naphthalene-2-sulphonate

EC Number:

286-122-7

EC Name:

Disodium 6-amino-5-[[4-[(2-bromo-1-oxoallyl)amino]-2-[(4-methyl-3-sulphonatophenyl)sulphonyl]phenyl]azo]naphthalene-2-sulphonate

Cas Number:

85187-33-3

Molecular formula:

C26H21BrN4O9S3.2Na

IUPAC Name:

disodium 6-amino-5-({4-[(2-bromoacryloyl)amino]-2-[(4-methyl-3-sulfonatophenyl)sulfonyl]phenyl}diazenyl)naphthalene-2-sulfonate

Test material form:

solid: particulate/powder