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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Abstracts of Papers for the Thirteenth Annual Meeting of the Society of Toxicology, Washington, D.C. March 10-14, I974
Author:
C. M. BURNETT, H.P. K. AGERSBORG, JR., J.F.BORZELLECEA.E ,E AGLE, A.G.EBERT, E.C.PIERCE, J.C. KIRRSCHMAN and R. A. SCALA, Inter-Industry Color Committee Task Force, Cosmetic, Toiletry and Fragrance Association, Inc., Washington, D.C
Year:
1974
Bibliographic source:
TOXICOLOGY AND APPLIED PHARMACOLOGY, 29,75-l 55 (1974)

Materials and methods

Principles of method if other than guideline:
Teratogenic toxicity Study of Red No. 4 in
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate
EC Number:
224-909-9
EC Name:
Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate
Cas Number:
4548-53-2
Molecular formula:
C18H16N2O7S2.2Na
IUPAC Name:
disodium 3-[(2,4-dimethyl-5-sulfonatophenyl)diazenyl]-4-hydroxynaphthalene-1-sulfonate
Constituent 2
Reference substance name:
FD&C Red No. 4
IUPAC Name:
FD&C Red No. 4
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report):Red No. 4- Molecular formula (if other than submission substance):C18-H14-N2-O7-S2.2NaC18-H16-N2-O7-S2.2Na- Molecular weight (if other than submission substance):480.4276 g/mole - Substance type:Organic - Physical state:No data available- Impurities (identity and concentrations):No data available

Test animals

Species:
rat
Strain:
not specified
Details on test animals or test system and environmental conditions:
Sex: Female

Administration / exposure

Route of administration:
oral: gavage
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Details on exposure:
No data available
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
No data available
Details on mating procedure:
No data available
Duration of treatment / exposure:
No data available
Frequency of treatment:
No data available
Duration of test:
No data available
No. of animals per sex per dose:
Femlae
Details on study design:
Administration was by gavage during organogenesis at doses based on the highest no-effect level in rats and dogs in prior 2-year feeding studies.

Examinations

Maternal examinations:
Maternal toxicity were observed
Ovaries and uterine content:
No data available
Fetal examinations:
Fetal toxicity, gross and histopathology were observed
Statistics:
No data available
Indices:
No data available
Historical control data:
No data available

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no effectsDetails on maternal toxic effects:No effect were observed on maternal toxicity of treated rats

Effect levels (maternal animals)

open allclose all
Dose descriptor:
NOAEL
Based on:
test mat.
Basis for effect level:
other: maternal toxicity
Dose descriptor:
NOAEL
Based on:
test mat.
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effectsDetails on embryotoxic / teratogenic effects:No effect was observed on skeletal or soft tissue abnormalities of pups in treated female rats were observed.

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Red No. 4 were considered to be non teratogenic in rats for F0and F1 generation
Executive summary:

In aTeratogenic Study, female rats were treated with Red No. 4orally by gavage during the period of organogenesis. No effect were observed on maternal toxicityof treated rats. In addition, no effect were observed on skeletal or soft tissue abnormalitiesof pups in treated female rats were observed.Therefore,Red No. 4 were considered to be non teratogenic in rats for F0 and F1 generation.