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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:
EU Method B.30 (Chronic Toxicity Studies)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
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