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EC number: 220-491-7 | CAS number: 2783-94-0
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Teratology study in rats. Compound FD&C Yellow No. 6.
- Author:
- International Research and Development Corporation
- Year:
- 1 972
- Bibliographic source:
- International Research and Development Corporation;Unpublished report no. 306-004 (1972)
- Reference Type:
- other: Authoritative data base
- Title:
- HSDB Number 4136
- Author:
- Hazardous Substances Data Bank
- Year:
- 2 011
- Bibliographic source:
- HSDB(Hazardous Substances Data Bank);US national Library of Medicine reviewed by SRC;WHO Food Additive Series 549: Sunset Yellow FCF (1964).
- Reference Type:
- other: Authoritative data base
- Title:
- GCID 181159
- Author:
- Aggregated Computational Toxicology Resource
- Year:
- 2 011
- Bibliographic source:
- ACToR(Aggregated Computational Toxicology Resource)[WHO Food Additive Series 549: Sunset Yellow FCF (1964).
- Reference Type:
- secondary source
- Title:
- International Research and Development Corporation (1972) Teratology study in rats. FD&C Yellow No. 6.
- Author:
- The International Association of Color Manufacturers/HPV Committee
- Year:
- 2 006
- Bibliographic source:
- Revised Robust Summaries for Sulfanilic acid (CAS No. 121 -57-3) and o-Toluene sulfonic acid, 4-amino-5-methoxy-(p-Cresidine sulfonic acid) (6471-78-9)
Materials and methods
- Principles of method if other than guideline:
- The developmental effects of FD&C Yellow No. 6 on Pregnant Charles River CD rats and their offspring by oral (gavage) route at different dose levels, on days 6-15 of gestation, were examined.
- GLP compliance:
- not specified
Test material
- 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
- Molecular formula:
- C16H12N2O7S2.2Na
- IUPAC Name:
- disodium 6-hydroxy-5-[(4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate
- Details on test material:
- - Name of test material: FD&C Yellow No. 6
- Molecular formula: C16H12N2O7S2.2Na
- Molecular weight: 454.38g/mole
- Substance type: organic
- Physical state: solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles River CD
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: methocel and retinoic acid
- Details on exposure:
- FD&C Yellow No. 6 was administered by gavage at dose levels of 100, 300 or 1000 mg/kg bw/day to 140 female Charles River CD rats. Three negative control groups (20/group) received the vehicle control while one control group received the positive control (7.5% mg/kg bw/day retinoic acid). All females were dosed on days 6-15 of gestation.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 9 days
- Frequency of treatment:
- Daily
- Duration of test:
- 20 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 300 or 1000 mg/kg/day
Basis:
no data
- No. of animals per sex per dose:
- 140 female Charles River CD rats.
Negative control:Three groups of 20 rats/group
Positive control: one group of 20 rats - Control animals:
- yes
- Details on study design:
- Three negative control groups were maintained and administered 0.5% methocel, while one positive control group was maintained and administered 7.5% mg/kg bw/day of retinoic acid.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No effect was observed on any other maternal parameters like body weight, corpora lutea, empty implantation sites, early resorptions, late resorptions, and live or dead term fetuses.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: no observed adverse effect
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No effect was observed on any fetal parameters evaluated like sex, external, internal and skeletal abnormalities. No teratogenicity was observed among the offspring.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
- Dose descriptor:
- LOAEL
- Effect level:
- 300 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The teratogenicity of FD&C Yellow No. 6 was observed at dose concentrations of 0, 100, 300 or 1000 mg/kg bw/day, but no effect observed in parents and their offsprings at a dose concentration of 100 mg/kg bw/day. At a dose concentration of 300 mg/kg bw/day effects were observed as the mean weights of the offspring were decreased.
Therefore the ‘No observed adverse effect level (NOAEL) for teratogenicity was considered to be 100 mg/kg bw/day, and the “lowest observed adverse effect level (LOAEL)” was considered to be 300 mg/kg bw/day. - Executive summary:
The study was designed to investigate the teratogenic effects of FD&C Yellow No. 6 to pregnant rats by oral (gavage) route. FD&C Yellow No. 6 was administered by gavage at dose levels of 0,100, 300 or 1000 mg/kg bw/day to 140 female Charles River CD rats on days 6-15 of gestation.
No compound related effectswere observedon early or late resorptions, empty implantation sites, body weight or numbers of live or dead fetuses. No teratogenicity was observed among the offspring at concentration 100 mg/kg bw/day.
The mean weights of the offspring from the 300 and 1000 mg/kg bw/day groups were decreased when compared to the average fetus weight of the combined negative controls.
Therefore the ‘No observed adverse effect level (NOAEL) for teratogenicity was considered to be 100 mg/kg bw/day,andthe“lowest observed adverse effect level (LOAEL)” was considered to be 300 mg/kg bw/day when administered orally.
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