Registration Dossier
Registration Dossier
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EC number: 234-426-5 | CAS number: 12003-38-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was cited in a reliable CIR monograph on the toxicity of Fluorphlogopite. No further information was provided.
Data source
Reference
- Reference Type:
- publication
- Title:
- Final Report on the Safety Assessment of Synthetic Fluorphlogopite as Used in Cosmetics
- Author:
- Becker, L.C.
- Year:
- 2 012
- Bibliographic source:
- Cosmetic Ingredient Review
Materials and methods
Test guideline
- Deviations:
- not applicable
- Remarks:
- - no information available
- Principles of method if other than guideline:
- Information on the guideline followed are not available.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- synthetic fluorphlogopite
- IUPAC Name:
- synthetic fluorphlogopite
- Details on test material:
- no details provided.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- No information available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on study design:
- No information available
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 9 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality reported
- Clinical signs:
- other: no adverse clinical signs
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of a published acute oral toxicity study in rats, the LD50 of Fluorphlogopite was > 9000 mg/kg bw.
- Executive summary:
The acute oral toxicity of synthetic Fluorphlogopite was investigated in female Sprague-Dawley rats. The LD50 value was > 9000 mg/kg bw.
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