Samarium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

not reported

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Justification for type of information:

The surface of samarium metal oxidises on contact with air to form an outer layer of samarium oxide. It is therefore considered appropriate to read across information from samarium oxide to the metal where testing on the metal is not technically possible.

Cross-reference

Reason / purpose for cross-reference:

other: read-across target

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted on read-across material

Justification for type of information:

The surface of samarium metal oxidises on contact with air to form an outer layer of samarium oxide. It is therefore considered appropriate to read across information from samarium oxide to the metal where testing on the metal is not technically possible.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 other: mg/kg

Based on:

test mat.

Data source

Reference

Reference Type:

publication

Title:

Acute Toxicological Evaluation of Samarium Oxide.

Author:

Lambert, C.E., Barnum, E.C. and R. Shapiro

Year:

1990

Bibliographic source:

Acute Toxicological Evaluation of Samarium Oxide (1990), UNOCAL, 1201 West 5th Street, Los Angeles, CA 90051.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

A Limit Dose of 5.0 g/kg was administered by gavage (50 % w/w solution in distilled water) to 10 fasted Sprague-Dawley rats (200-300 g) using 5/sex. Animals were observed for clinical signs for 14 days following dosing.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

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:

Samarium (III) oxide

Test material form:

solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

DOSAGE
5.0 g/kg as a 50 % w/w solution in distilled water

Doses:

5.0 g/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 other: mg/kg

Based on:

test mat.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

Under the conditions of the study the acute oral LD50 to male and female Sprague dawley rats was determined to be in excess of 5 000 mg/kg.

Executive summary:

The acute oral toxicity of the test material, samarium oxide, was investigated.

During the study, a Limit Dose of 5.0 g/kg was administered by gavage (50 % w/w solution in distilled water) to 10 fasted Sprague-Dawley rats (200-300 g) using 5/sex. Animals were observed for clinical signs for 14 days following dosing.

Under the conditions of the study the acute oral LD50 to male and female Sprague dawley rats was determined to be in excess of 5 000 mg/kg.