Registration Dossier
Registration Dossier
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EC number: 235-043-6 | CAS number: 12060-58-1
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicological and pharmacological effects of gadolinium and samarium chlorides
- Author:
- T. J. Haley, K. Raymond, N. Komesu, and H. C. Upham
- Year:
- 1 961
- Bibliographic source:
- Br J Pharmacol Chemother. 1961 December; 17(3): 526–532.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.30 (Chronic Toxicity Studies)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Samarium (III) oxide
- EC Number:
- 235-043-6
- EC Name:
- Samarium (III) oxide
- Cas Number:
- 12060-58-1
- Molecular formula:
- O3Sm2
- IUPAC Name:
- disamarium(3+) trioxidandiide
- Details on test material:
- - purity 99%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- The chronic toxicity of samarium chlorides was determined by including 0.01, 0.l and 1% of the compound in the diet and feeding it over a period of 12 weeks to 3 groups of rats.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.01 %
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
0.1 %
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
1%
Basis:
nominal in diet
- No. of animals per sex per dose:
- 6 per sex and dose
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- Observations were made of the following: total erythrocytes, total leucocytes, differential cell count, haemoglobin, haematocrit and body weight.
- Sacrifice and pathology:
- At the conclusion of the study the following tissues were examined histologically: heart, lung, liver, kidney, pancreas, spleen, adrenal and small intestine.
Results and discussion
Results of examinations
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Samarium chloride at all concentrations up to 1% used in the diet produced no histopathological changes in any of the organs studied.
Effect levels
- Dose descriptor:
- NOAEL
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: 1% in feed over a period of 12 weeks
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
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.
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