Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
Type of information:
experimental study planned
Study period:
2021-2022
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out : Disperse Violet 057

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 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 data included studies conducted according to - OECD Guideline 471 (Bacterial reverse mutation assay) and - OECD Guideline 476 (In vitro mammalian cell gene mutation assay)
- Weight of evidence : Sufficient data on the substance or read across analogues is not available to be able to establish a weight of evidence argument.
- Grouping and read-across : Sufficient data on the substance or read-across analogues is not available 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 [if relevant]: OECD Guideline 489: Test No. 489: In Vivo Mammalian Alkaline Comet Assay

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
Type of assay:
mammalian comet assay

Test material

Constituent 1
Chemical structure
Reference substance name:
1-hydroxy-4-[[4-[(methylsulphonyl)oxy]phenyl]amino]anthraquinone
EC Number:
216-475-4
EC Name:
1-hydroxy-4-[[4-[(methylsulphonyl)oxy]phenyl]amino]anthraquinone
Cas Number:
1594-08-7
Molecular formula:
C21H15NO6S
IUPAC Name:
1-hydroxy-4-[[4-[(methylsulphonyl)oxy]phenyl]amino]anthraquinone
Test material form:
not specified
Details on test material:
None

Results and discussion

Applicant's summary and conclusion