Registration Dossier
Registration Dossier
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EC number: 220-168-0 | CAS number: 2650-18-2
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
- Remarks:
- The study is conducted on a read across test material. The complete read across justification is attached in section 13. The reliability of the original study is 4.
Data source
Reference
- Reference Type:
- publication
- Title:
- Teratogenic Study with Certified Colors in Rats and Rabbits
- Author:
- Burnett, C.M; Agersborg, H.P.K.; Eagle, E.; Ebert, A.G.; Pierce, E.C.; Kirschman, J.C. and Scala, R.A. (Inter-Industry Color Committee Task Force, Cosmetic, Toiletry and Fragrance Association, Inc., Washington, D.C.)
- Year:
- 1 974
- Bibliographic source:
- Toxicol. Appl. Pharmacol. 29, 121 (1974)
Materials and methods
- Principles of method if other than guideline:
- "Standard teratogenicity protocol" (treatment during organogenesis)
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Similar Substance 1
- IUPAC Name:
- Similar Substance 1
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- The studies were done in commercial contract laboratories using a standard protocol fortified with additional control groups.
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- Doses based on the highest no-effect level in rats and dogs in prior 2-year-feeding studies.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- during organogenesis
Doses / concentrations
- Dose / conc.:
- 630 mg/kg bw/day
- No. of animals per sex per dose:
- No data
- Control animals:
- yes
Results and discussion
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
None of the colors produced evidence of skeletal or soft tissue abnormalities in the fetuses.
Effect levels (fetuses)
- Dose descriptor:
- NOEL
- Effect level:
- >= 630 mg/kg bw/day
- Based on:
- not specified
- Sex:
- female
- Basis for effect level:
- other: absence of teratogenicity
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
