Samarium

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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:

skin irritation: in vivo

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

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: not specified

Score:

0

Remarks on result:

no indication of irritation

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:

no guideline followed

Principles of method if other than guideline:

0.5 g dose was applied to one intact and one abraded skin site (approx. 2.5 cm²) of six rabbits (New Zealand Albino) and occluded for 24 hours. The patches were then removed and the test sites wiped. The sites were evaluated 24 and 72 hours after initial exposure according to the method of Draize.

GLP compliance:

not specified

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:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

other: one intact and one abraded skin site per animal

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g

Duration of treatment / exposure:

24 hours

Observation period:

72 hours following test material application.

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm²

REMOVAL OF TEST SUBSTANCE
The patches were removed 24 hours after test material application and the test sites wiped.

OBSERVATION TIME POINTS
The sites were evaluated 24 and 72 hours after initial exposure.

SCORING SYSTEM:
Sites were evaluated according to the method of Draize.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: not specified

Score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

There were no signs of dermal irritation.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

Under the conditions of the study no signs of dermal irritation were noted. The Primary Dermal Irritation Index was 0. The test material was therefore concluded not to be a skin irritant.

Executive summary:

The skin irritation potential of the test material, samarium oxide, was investigated.

During the study, a 0.5 g dose was applied to one intact and one abraded skin site (approx. 2.5 cm²) of six rabbits (New Zealand Albino) and occluded for 24 hours. The patches were then removed and the test sites wiped. The sites were evaluated 24 and 72 hours after initial exposure according to the method of Draize.

Under the conditions of the study no signs of dermal irritation were noted. The Primary Dermal Irritation Index was 0. The test material was therefore concluded not to be a skin irritant.