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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drogs and Cosmetics" published by the Editorial Committee of the Association of Food and Drug Officials of the United States of America.
Version / remarks:
1965
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3-5 months
- mean weight at study initiation: males 2.90 kg, females 2.73 kg
- Housing: Rabbits were caged singly in a room.
- Diet: commercial irradiated diet (Styles-Oxoid) was fed ad libitum and sterile filtered water was available at all times.
- Acclimation period: six rabbits were maintained under pretest conditions for one week prior to the test

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): Animals were exposed to fifteen hours of artificial light from 8.00 hours to 23.00 hours daily.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and shaved
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of the test substance was mixed with 0.5 mL 66 OP Industrial Spirit
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Application side: back
- % coverage: at least 10% of the total body surface
- Type of wrap if used: aluminium foil secured with "sleek" adhesive tape, which was in turn covered by Coban 6 wide self-adhering elastic bandages

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h, 72h
Score:
0.09
Max. score:
4
Reversibility:
fully reversible
Remarks:
after 72 h
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h, 72h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin
Irritant / corrosive response data:
Due to the staining of the stratum corneum by the test compound, it was impossible to assess the degree of erythema.

Any other information on results incl. tables

Histopathological report on Biopsy Specimens:

One animal No. 15 revealed a minimal acanthosis of the epidermis. This lesion is of little significance and is such as might be caused by clipping and cleaning the area of skin involved.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met