Registration Dossier
Registration Dossier
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EC number: 257-804-1 | CAS number: 52277-71-1
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: gene mutation
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Study period:
- not yet defined
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- see attached justification
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
- GLP compliance:
- yes
- Type of assay:
- mammalian comet assay
Test material
- Reference substance name:
- Reaction mass of sodium [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and sodium bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and sodium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-)
- IUPAC Name:
- Reaction mass of sodium [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and sodium bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and sodium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-)
Constituent 1
Test animals
- Species:
- rat
Administration / exposure
- Route of administration:
- oral: gavage
Results and discussion
Test results
- Sex:
- not specified
- Genotoxicity:
- other: to be performed
- Remarks on result:
- other: the test is in read across from a submitted testing proposal still under evaluation
Applicant's summary and conclusion
- Executive summary:
A read across approach is proposed for assessing the in vivo gene mutation properties of Solvent Black 7 EC 257-804-1, by using the results of a Comet Assay OECD 489 submitted as testing proposal on substance Acid Black 63:3 EC 915-756-5.
The Comet Assay requirement is the results of the application of Column 2 Annex VII of the REACH Regulation which requires that substances with positive results for in vitro gene mutation study in bacteria are further investigated for their mutagenic properties in vivo.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
