Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from similar mixture/product
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Amended Final Report on the Safety Assessment of Oryza Sativa (Rice) Bran Oil, Oryza Sativa (Rice) Germ Oil, Rice Bran Acid, Oryza Sativa (Rice) Bran Wax, Hydrogenated Rice Bran Wax, Oryza Sativa (Rice) Bran Extract, Oryza Sativa (Rice) Extract, Oryza Sat
- Year:
- 2 006
- Bibliographic source:
- International Journal of Toxicology - CIR database
- Report date:
- 2006
Materials and methods
- Principles of method if other than guideline:
- Data are extracted from the 2006 review of the International Journal of Toxicology about the assessment of rice derivates. Since the study reported is dated back to 2000 (Cosmepar. 2000. Study of the innocuousness of a product by single oral administration. Unpublished data submitted by CTFA, June 20, 2002. 17 pages) we assume that it was performed according to OECD 401
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Hydrolyzed Rice Protein
- IUPAC Name:
- Hydrolyzed Rice Protein
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2 g/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- other: No mortality or other clinical signs were reported.
- Effect level:
- > 2 000 mg/kg bw
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not toxic for ingestion according to criteria set out in Regulation (EC) n. 1272/2008 (CLP)
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.
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