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Registration Dossier
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EC number: 947-136-5 | CAS number: -
Skin irritation / corrosion
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:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
Test animals
- Species:
- rabbit
- Details on test animals or test system 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).
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