Registration Dossier

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:
1991

Materials and methods

Type of assay:
micronucleus assay

Test material

Constituent 1
Reference substance name:
FD & C Yellow No. 6
IUPAC Name:
FD & C Yellow No. 6
Constituent 2
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

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.