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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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: "Appraisal of the safety of chemicals in foods, drugs and cosmetics (1959) of the US Association of Food and Drug Official (AFDO).
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
None

Test animals

Species:
rabbit
Strain:
other: Russian breed
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kgs
- Housing: In order to prevent injuries by bites the rabbits were kept separately in V2A wire mesh cages
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Remarks:
on the whole back and flanks two days before treatment with an electric clipper
Vehicle:
other: PEG 400 (Polyethylene glycol)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
FAT 40069/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made.
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 rabbits (3 males and 3 females)
Details on study design:
Rabbits were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. The gauze patches were removed 2 4 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it, on the basis of the following evaluation scheme.

SCORING SYSTEM:

Erythema and Eschar Formation
- No erythema: 0
- Very slight erythema (barely perceptible): 1
- Well defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Total possible erythema score: 4

Edema Formation
- No edema: 0
- Very slight edema (barely perceptible): 1
- Slight edema (edges of area well defined by definite raising: 2
- Moderate edema (raised approximately 1 mm): 3
- Severe edema (raised more than 1 mm and extending beyond area of exposure): 4
Total possible edema score: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks:
Intact Skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0.5
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
None
Other effects:
None

Any other information on results incl. tables

Evaluation of the skin reactions:

Animal No. / Sex Skin Reaction 24 hours after application 72 hours after application
Intact skin sacrificed skin Intact skin sacrificed skin
1/M Erythema 0 0 0 0
Oedema 0 1 0 0
2/M Erythema 0 0 0 0
Oedema 2 2 0 1
3/M Erythema 0 0 0 0
Oedema 0 1 0 0
4/F Erythema 0 0 0 0
Oedema 0 0 0 0
5/F Erythema 0 0 0 0
Oedema 0 2 0 0
6/F Erythema 0 0 0 0
Oedema 1 1 0 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40069/A is considered as non-irritant to the rabbit skin.
Executive summary:

A study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 40069/A, on the skin of the rabbits according to the "Appraisal of the safety of chemicals in foods, drugs and cosmetics (1959) of the US Association of Food and Drug Official (AFDO). Six rabbits (3 males and 3 females), Russian breed, were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. FAT 40069/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it. In conclusion, The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.5. FAT 40069/A is to be considered as a non-irritant to the skin of rabbits.