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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:
From November 17, 1981 through November 21, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Well documented GLP study performed according to a method similar to OECD Guideline 404. Next to intact shaved skin, also abraded skin was exposed to the test substance. Exposure duration was 24h (instead of 4h). An occlusive (instead of a semi-occlusive) dressing was applied.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Also abraded skin was exposed. Exposure for 24h. Occlusive dressing used.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 4236-43-5, Order #J-86
- Substance type: Yellow liquid
- Physical state: liquid
- Purity: responsibility of the sponsor
- Stability: There was no apparent change in the physical state of the test article during administration
- Other: pH 10.2-10.3

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Perfection Breeders, Inc., Douglasville, Pennsylvania
- Weight at study initiation: 2 - 3 kilograms
- Housing: Separate isolation by the test system; rabbits were housed individually in cages sized in accordance with the "Guide for the Care of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum, checked daily and added or replaced as needed. Feeders are designed to reduce soiling, bridging, and scattering
- Water (e.g. ad libitum): Availability - fresh tap water, fit for human consumption, ad libitum, using 16 ounce glass bottles with rubber stopper and stainless steel sipper tube or an automatic watering system supplied by Edstrom Industries Inc., Waterford, Wisconsin.
- Acclimation period: five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/site
Duration of treatment / exposure:
24 hours
Observation period:
Animals were observed for signs of erythema and edema and scored according to the Draize scale at 1, 24, 48 and 72 hours after application of the test material.
Number of animals:
Six (three males, three females)
Details on study design:
TEST SITE
- Area of exposure: The test article was administered at two skin sites, one abraded and one intact site.
- Type of wrap if used: Following nthe application of the test material, one-inch square gauze patches were applied to each of the two sites. The trunk of the animal was then wrapped with a rubber dam and an Ace bandage to retard evaporation.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the 24 hour exposure period, the wrappings were removed and the skin wiped to remove any remaining material. Animals were observed for signs of erythema and edema and scored according to the Draize scale at 1, 24, 48 and 72 hour after the application of the test material.

SCORING SYSTEM: Draize evaluation of dermal irritation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
based on 6 animals
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Only intact skin taken into account
Irritation parameter:
edema score
Basis:
mean
Remarks:
based on 6 animals
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Only intact skin taken into account
Irritant / corrosive response data:
Slight erythema was visible only at one hour after bandage removal in 3 animals. No edema was observed throughout the study.
Other effects:
No effects on body weight.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the observations made in the primary dermal irritation study in rabbits, the test article was not considered to be a dermal irritant. Based on the results of this test and the criteria of the CLP Regulation, the substance should not be classified for skin irritation.