Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo
Type of information:
other: read across from supporting substance (analogue substance or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test was performed according to internationally accepted testing guidelines.The complete justification for the Read Across approach is reported in the Section 13.

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 (AFDO)
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: from 1.4 to 2.3 kg
- Housing: metal cages
- Diet and water: fed with standard diet of Nafag and drinking water ad libitum
- Acclimation period: the animals were acclimatized to the environment in laboratories for at least 8 days

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

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
Amount of 0.5 g of test substance were applied
Duration of treatment / exposure:
The gauze patches were removed 24 hours after application
Observation period:
The reaction of the skin was appraised upon removal during an observation period of 8 days
Number of animals:
6 (3 males and 3 females) rabbits
Details on study design:
TEST SITE
- Area of exposure: shaved one day before treatment. The shaved skin area on the left side was slightly scarified immediately before treatment. A gauze patch of 2.5x2.5 cm laden with the test substance was immediately applied to the prepared skin.
- Type of wrap if used: the patch was covered with an impermeable foil of 5x5 cm, which was fixed to the body of the animals with adesive tape.

SCORING SYSTEM: The reaction of the skin was appraised upon removal during an observation period of 8 days.

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:
animal: all animals
Time point:
other: mean score after 24, 48 and 72 hours
Score:
0
Reversibility:
other: No skin reaction observed
Irritation parameter:
edema score
Basis:
animal: all animals
Time point:
other: mean score after 24, 48 and 72 hours
Score:
0
Reversibility:
other: No skin reaction observed
Irritant / corrosive response data:
The test substance was found to be non irritant when applied to intact or abraded rabbit skin, after an observation period of 8 days. The mean score for each animal is zero.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information according to the CLP Regulation Criteria used for interpretation of results: EU
Conclusions:
The test substance was found to be non irritant when applied to intact or abraded rabbit skin.
Executive summary:

METHOD

The skin irritation test was performed to rabbit skin using a single administration, according to the "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

RESULT/CONCLUSION

The criteria for the evaluation of the skin irritation potential followed in the test are different from those reported into the OECD guideline. Nevertheless, the scoring system used for the erythema and eschar formation and for oedema formation are the same of that reported into the OECD. Since the raw tables are included into the study report, it is possible to re-evaluate the results according to the CLP Regulation (EC n. 1272/2008).

The test substance was found to be non irritant when applied to intact or abraded rabbit skin.

Therefore, the test substance can be classified as NON IRRITATING, according to the CLP Regulation (EC n. 1272/2008).