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Administrative data

Description of key information

Samarium chloride at all concentrations up to 1% used in the diet produced no histopathological changes in any of the organs studied.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
EU Method B.30 (Chronic Toxicity Studies)
GLP compliance:
not specified
Test material information:
Composition 1
Species:
rat
Strain:
not specified
Sex:
male/female
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.
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
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.
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.
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
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Study duration:
chronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Mode of Action Analysis / Human Relevance Framework

Additional information

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Test material is same like Samarium chloride.

Justification for classification or non-classification

There is conclusive data available which is not sufficient for classification.