Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
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: Acid Red 195

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.

OECD Guideline 471 (Bacterial Reverse Mutation Assay)
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
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 [if relevant]: OECD Test Guideline 474: Mammalian Erythrocyte Micronucleus Test.

Data source

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromium
EC Number:
271-352-2
EC Name:
[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromium
Cas Number:
68541-72-0
Molecular formula:
C20H13CrN4O5S
IUPAC Name:
[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromium
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Results and discussion

Applicant's summary and conclusion