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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:
October 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 guideline
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 Officials (AFDO)
Deviations:
not specified
Principles of method if other than guideline:
Irritation potency of FAT 40062/A on the rabbit skin of both sexes observed over a period of 72 hours by treating with 0.5 g of the test substance.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): FAT 40062/A

Test animals

Species:
rabbit
Strain:
other: Russian breed
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Huntsman/ CIBA-GEIGY Limited
- Weight at study initiation: 1.5 to 2 kgs
- Housing: Kept separately in V2A wire cages,
- Diet: (NAFAG, Gossau SG, rabbit food ad libitum
- Water: ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Remarks:
with electric clipper
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g of test substance FAT 40062/A was applied to each side.
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6 rabbits (3 males/ 3 females)
Details on study design:
Six rabbits (3 males/3 females) of the Russian breed, weighing 1.5 to 2 kgs,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 (0.5 g) and immediately applied to the prepared skin. Before application a 50 % polyethylene glycol trituration (PEG 400) was made.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 24 h after the application. The reaction of the skin was appraised upon removal and 72 h after it.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
Intact and scarified skin
Basis:
mean
Remarks:
6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact and scarified skin
Basis:
mean
Remarks:
6 rabbit
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
6 rabbit
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No adverse effects were observed after treatment.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40062/A is to be considered as non-irritant to the rabbit skin.
Executive summary:

Test was performed to evaluate irritant effects after single application of FAT 40062/A on rabbit Skin by following patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). Primary irritation to the skin is measured by a patch test technique on the abraded and intact skin of the Russian breed rabbits, clipped free of hair. Six rabbits (3 males/3 females) weighing 1.5 to 2 kgs,were shaved on the whole back and flanks two days before treatment with an electric clipper. In order to prevent injuries by bites the rabbits were kept separately in V2A wire cages. The shaven skin on the left side was slightly scarified immediately before treatment by application of 50 % Polyethylene glycol trituration (PEG 400). A gauze patch 2.5 x 2.5 cm was soaked with the test substance (0.5g) 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 24 h after the application. The reaction of the skin was appraised upon removal and 72 h after it. The primary irritation index along with erythema and edema to the skin of rabbits was found to be '0'. Therefore, FAT 40062/A is to be considered as non-irritant to the skin of rabbits.