Registration Dossier
Registration Dossier
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EC number: 237-410-6 | CAS number: 13775-53-6
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study in conformance with requirements of the standard repeated dose toxicity testing protocols, assessment taken from EU-RAR.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
- Principles of method if other than guideline:
- Study in conformance with requirements of the standard repeated dose toxicity testing protocols.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Details on test material:
- synthetic cryolite
purity: 96%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)BR
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- continuously
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
50, 5000, and 50000 ppm
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
3.8, 399.2, and 4172.3 mg/kg bw/day in males; 4.5, 455.9, and 4758.1 mg/kg bw/day in females
Basis:
- No. of animals per sex per dose:
- 40
- Control animals:
- yes
Results and discussion
Results of examinations
- Details on results:
- At 50000 ppm male and female rats exhibited reduced body weights and decreases in haemoglobin and haematocrit. At necropsy the stomach of male and female rats receiving ≥5000 ppm exhibited thickened walls, dark contents, raised focal areas, glandular thickened walls, non-glandular light focal areas, glandular dark focal areas and red glandular areas. Microscopical examination revealed submucosal lymphoid foci, hyperplasia, hyperkeratosis/acanthosis, erosion/ulcerations, mucosal atrophy and chronic submucosal inflammation. Fluoride accumulated in bones and teeth at all dose levels. The LOAEL for fluoride accumulation for male and female rats was 50 ppm, representing 3.8/4.5 mg/kg bw/day. The NOAEL for this effect could not be determined in this study. The LOAEL for lesions observed in the stomach was 5000 ppm (399.2 mg/kg bw/day in males and 455.9 mg/kg bw/day in females). The NOAEL for stomach effects in rats was 50 ppm, representing 3.8 mg/kg bw/day in males and 4.5 mg/kg bw/day in females.
Effect levels
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 3.8 other: mg/kg bw/day
- Sex:
- male
- Basis for effect level:
- other: fluoride accumulation in bones and teeth
- Dose descriptor:
- LOAEL
- Effect level:
- 4.5 other: mg/kg bw/day
- Sex:
- female
- Basis for effect level:
- other: fluoride accumulation in bones and teeth
Target system / organ toxicity
- Critical effects observed:
- not specified
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.
