Registration Dossier
Registration Dossier
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EC number: 204-482-5 | CAS number: 121-57-3
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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Sufficiently well documenten publication
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- FD & C Yellow No. 6
- IUPAC Name:
- FD & C Yellow No. 6
- Reference substance name:
- Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate
- EC Number:
- 220-491-7
- EC Name:
- Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate
- Cas Number:
- 2783-94-0
- IUPAC Name:
- disodium 6-hydroxy-5-[(4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate
Constituent 1
Constituent 2
Test animals
- Species:
- other: mouse and rat
Administration / exposure
- Route of administration:
- oral: gavage
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500, 1000, 2000 mg/kg bw
Basis:
Results and discussion
Test results
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- no effects
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
FD & C Yellow No. 6, which is rapidly and almost completely metabolised in the gut inter alia to sulphanilic acid, i.e. the registered substance, gave a negative result in both rat and mouse bone marrow micronucleus tests after a single oral dose of up to 2000 mg/kg. - Executive summary:
FD & C Yellow No. 6, which is rapidly and almost completely metabolised in the gut inter alia to sulphanilic acid, i.e. the registered substance, gave a negative result in both rat and mouse bone marrow micronucleus tests after a single oral dose of up to 2000 mg/kg.
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