Registration Dossier
Registration Dossier
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Reaction mass of tetrasodium [mono(4,4'-(1Z,1'Z)-(4,4'-dioxidobiphenyl-3,3'-diyl)bis(diazene-2,1-diyl)bis(5-amino-3-oxidonaphthalene-2,7-disulfonate(3-)) cuprate (4-)] and tetraammonium [mono(4,4'-(1Z,1'Z)-(4,4'-dioxidobiphenyl-3,3'-diyl)bis(diazene-2,1-diyl)bis(5-amino-3-oxidonaphthalene-2,7-disulfonate(3-)) cuprate (4-)]
EC number: 943-486-8 | CAS number: -
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Direct Blue 267
- IUPAC Name:
- Direct Blue 267
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- distilled water
- No. of animals per sex per dose:
- 15 males at 400 mg/kg sacrificed at 24, 48 an 72h ( 5 males at each time point)15 females at 400 mg/kg sacrificed at 24, 48 and 72h (5 females at each time point)
Results and discussion
Test results
- Sex:
- not specified
- Genotoxicity:
- negative
- Remarks:
- P/N ratio not significantly changed
- Toxicity:
- yes
- Additional information on results:
- No apparent citotoxicity effect: PCE/NCE ratio
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negativeThe substance was tested for in vivo genotixicity following in vivo test OECD 474. Under the experimental conditions the P/N is not significantly changed.
- Executive summary:
The substance was tested for in vivo genotixicity following in vivo test OECD 474. Mice were orally dosed at 400 mg/kg (maximum tolerated dose) and sacrified at 24, 48 and 72h. No apparent citotoxicity was observed and the P/N was not significantly changed.
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