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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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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:
1961
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

Constituent 1
Chemical structure
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%

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