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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 'Appraisal of the safety of chemicals in Food, Drugs and Cosmetics' 1959 of the US Association of Food and Drug officials.
Principles of method if other than guideline:
Patch-test technique
GLP compliance:
no
Remarks:
pre GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Russian breed
- Weight at study initiation: 1.5 to 2 kg
- Housing: individual housing in metal cages, 47 × 32 × 34 cm.
- Diet: ad libitum, standard - Nafag.
- Water: ad libitum.
- Acclimation period: 8 days minimum.

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod: 14 hours light/day

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 ml
Duration of treatment / exposure:
The gauze patches were removed 24 hours after application.
Observation period:
8 days
Number of animals:
6 rabbits: 3 males, 3 females
Details on study design:
TEST SITE
- Area of exposure: rabbits were shaved one day before treatment with an electric clipper on the flanks. The shaved skin area on the left side was slightly scarified just before treatment.
- Type of wrap if used: a gauze patch 2.5 x 2.5 cm was laden with the test substance and immediately applied to the prepared skin. The patch was covered with an impermeable foil of 5x5 cm, which was fixed to the body of the animals with adhesive tape.

SCORING SYSTEM
The reaction of the skin was appraised upon removal during an observation period of 8 days on the basis of the following evaluation scheme.

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

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 6/6
Time point:
other: mean 24, 48 and 72 h
Score:
< 2.3
Remarks on result:
other: both intact and abraded skin
Irritation parameter:
edema score
Basis:
animal: 6/6
Time point:
other: mean 24, 48 and 72 h
Score:
< 2.3
Remarks on result:
other: both intact and abraded skin
Irritant / corrosive response data:
Under the test conditions, the test item was found to be non irritant w'hen applied to intact or abraded rabbit skin.

Any other information on results incl. tables

24 hrs 48 hrs 72 hrs
Males Females Males Females Males Females
206 28 210 196 13 195 206 28 210 196 13 195 206 28 210 196 13 195
Intact skin
Erythema 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Oedema 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Abraded skin
Erythema 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Oedema 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

4 days 8 days
Males Females Males Females
206 28 210 196 13 195 206 28 210 196 13 195
Intact skin
Erythema 0 0 0 0 0 0 0 0 0 0 0 0
Oedema 0 0 0 0 0 0 0 0 0 0 0 0
Abraded skin
Erythema 0 0 0 0 0 0 0 0 0 0 0 0
Oedema 0 0 0 0 0 0 0 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritating
Executive summary:

In order to calculate the primary irritation index a patch test assay was performed, as 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).

6 rabbits were shaved one day before treatment with an electric clipper on the flanks. The shaved skin area on the left side was slightly scarified just before treatment. The test substance was applied to each side in quantities of 0.5 ml. The gauze patches were removed 24 hours after application and the reaction of the skin was appraised upon removal during an observation period of 8 days.

Under the test conditions, the test item was found to be non irritant when applied to intact or abraded rabbit skin.

Discussion and conclusion

The scoring system criteria used to record the hardness of the skin reactions followed in the current test are the same as those reported into the OECD guideline, therefore it is possible to re-evaluate the results according to the CLP Regulation (EC 1272/2008), because the raw tables are included into the study report.

Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions (in both intact and abraded skin).

In conclusion, the test item can be not classified as irritating, according to the CLP Regulation (EC 1272/2008).