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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: experimnental result on similar substance
Adequacy of study:
key study
Study period:
From December 11 to 19, 1978
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:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO)
GLP compliance:
no
Remarks:
Study conducted before 1981

Test material

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

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: WIGA Versuchstierzuchtanstalt, 8741 Sulzfeld, Germany
- Weight at study initiation: 1.5 to 2 kg
- Housing: housed individually in metal cages
- Diet: standard rabbit food - NAFAG, Gossau SG ad libitum
- Water: ad libitum
- Acclimation period: for a minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: propylene glycol + saline (70 : 30 parts)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g of test material
- Concentration: 50 %
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
3 male and 3 female
Details on study design:
PREPARATION
Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "SchröpfSchnäpper", Aesculap, Switzerland
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patches. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal: 265, 267, 268, 269
Time point:
other: mean score following grading at 24, 48, 72 hours
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal:
Time point:
other: 266, 270
Score:
ca. 0
Max. score:
0
Reversibility:
other: No dermal effects observed
Remarks on result:
other: intact skin

Any other information on results incl. tables

Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975).

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Non irritant
Executive summary:

Method:

The skin irritation was determined in an irritation test on rabbits according to the Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959), the US Association of Food and Drug Officials (AFDO), similar to OECD guideline 404. During the test 3 male and 3 female of Hymalaian rabbit were exposed to the substance on intact and abradeed skin, nevertheless in order to evaluate the irritation potential of the substance only the scores registered on intact skin were considered.

Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975).

Result:

Not irritating