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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:
19 December, 1978 - 31 January, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Conducted prior to GLP, and the availabilty of OECD guidelines. No information on the purity of the test sample, limited information on the animals and the conditions of the testing (such as no information on temperature and humidity, the quantity of test suibstance applied if a patch was used, the surface of the patch, how the patch was kept in contact with the skin)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
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:
- Name of test material (as cited in study report): BUSAN 11-1M
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: 47601
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
- Other: No data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lesser's Rabbitry, Union Grove, WI
- Age at study initiation: No data
- Weight at study initiation: Males2390 - 2586 g, females 2190 - 2570 g
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: 08/02/1979 To:11/02/1979

Test system

Type of coverage:
not specified
Preparation of test site:
abraded
Vehicle:
other: wetted with 0.9% saline
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): no data

VEHICLE
- Amount(s) applied (volume or weight with unit): wetted with 0.9% saline
- Purity: no data
Duration of treatment / exposure:
72 hours
Observation period:
72 hours
Number of animals:
6 (3 male and 3 female)
Details on study design:
TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data

SCORING SYSTEM:
Draize, J.H. 1965, Appraisal of the safety of chemicals in foods, drugs and cosmetics, Associateion of the Food and Drug Officials of the US, Topeka, Kansas

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
0.04
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hour
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hour
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
No further data
Other effects:
No further data

Any other information on results incl. tables

No further data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material did cause irritation or corrosion to the skin and therefore is not classified for skin irritation/corrosion according to EU criteria
Executive summary:

In a study conducted in 1979, the test substance Busan 11-M1was examined for its ability to cause skin irritation when tested on intact and abraded rabbit skin. The exposure sites on each animal were shaved and then two sites were left intact and two sites were abraded prior to exposure. The test substance wetted with saline was applied under a gauze pad to the sites. The skin reactions of each test animal were observed for 72 hours. Slight erythema with developed which was fully reversible and was not accompanied by any other irritation reactions. Under the conditions of this study, the test substance Busan 11-M1was considered not to be irritating to intact or abraded rabbit skin. Based on these results, the test substance does not warrant classification for skin irritation in accordance with Regulation EC No. 1272/2008.