Registration Dossier
Registration Dossier
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Reaction mass of sodium(E)-6,7'-carbonylbis(azanediyl)bis(4-hydroxy-3-((E)-phenyldiazenyl) naphthalene-2-sulfonate) and disodium 3-[(4-acetamidophenyl)azo]-4-hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-sulphonato-2-naphthyl]amino]carbonyl]amino]naphthalene-2-sulphonate and disodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-(phenylazo)naphthalene-2-sulphonate]
EC number: 939-268-7 | CAS number: -
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- other: experimental result on similar substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Disazo Red DK 618
- Author:
- Ciba geigy
- Year:
- 1 992
- Bibliographic source:
- National Industrial Chemicals Notification and Assessment Scheme
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- in 1 % carboxymethylcellulose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5000 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5/sex/group
- Positive control(s):
- Cyclophosphamide
Examinations
- Tissues and cell types examined:
- Bone marrow samples were scored for polychromatic erythrocytes containing micronuclei at 24, 48 and 72 hours post-dosing.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- some cytotoxicity
- Negative controls validity:
- not valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Under experimental conditions substance did not appear to induce micronuclei.
- Executive summary:
Substance was investigated for its potential to induce micronuclei in polychromatic erythrocytes in mouse bone marrow. NMRI mice (5/sex/group) were given the test substance (in 1% carboxymethylcellulose) as a single oral dose at 5000 mg/kg. Bone marrow samples were scored for polychromatic erythrocytes containing micronuclei at 24, 48 and 72 hours post-dosing. The ratio of polychromatic to normochromatic erythrocytes indicated some cytotoxicity at the dose level used. However, the number of cells with micronuclei in the tested animals was similar that in control animals. Cyclophosphamide was used as a positive control.
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