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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:
February 27, 1984 - February 29, 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Well documented study performed according to a method similar to OECD Guideline 404 with a minor deviation: occlusive dressing used instead of semi-occlusive

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Occlusive dressing used instead of semi-occlusive
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 5601-23-1
- Substance type: Clear liquid
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harvey's Lake, Pennsylvania
- Weight at study initiation: 2 - 3 kilograms
- Housing: Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/stie
Duration of treatment / exposure:
4 hours
Observation period:
Animals were observed at 4 and 48 hours after application of the test material.
Number of animals:
Iniatially, two rabbits will be administered the test article. The test will be considered positive if both animals exhibit a positive response and the study will be terminated. If only one animal or no animals exhibit a positive response, the test will be repeated with a different group of two rabbits. If one animal exhibits a positive response in the second group, the test article will be considered corrosive and the study will be terminated provided there was no positive response in group I. If no positive reactions are observed in group II, an additional group of two rabbits will be added and conclusions will be based on a total of six rabbits.
Details on study design:
SCORING SYSTEM:
Corrosion will be considered to have resulted if the substance in contact with the rabbit skin has caused destruction or irreversible alteration of the tissue on at least two out of each six rabbits tested. Tissue destruction is considered to have occurred if, at any of the readings, there is ulceration or necrosis. Tissue destruction does not include merely sloughing of the epidermis or erythema, edema or fissuring.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Skin necrosis
Basis:
animal #1
Time point:
other: 4h
Reversibility:
not reversible
Remarks on result:
other: skin necrosis was visible at 4h in two animals
Irritation parameter:
other: Skin necrosis
Basis:
animal #2
Time point:
other: 4h
Reversibility:
not reversible
Remarks on result:
other: skin necrosis ws visible at 4h in two animals
Irritation parameter:
other: Skin necrosis
Basis:
animal #1
Time point:
48 h
Reversibility:
not reversible
Remarks on result:
other: Skin necrosis was visible in two animals
Irritation parameter:
other: Skin necrosis
Basis:
animal #2
Time point:
48 h
Reversibility:
not reversible
Remarks on result:
other: Skin necrosis was visible in two animals
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Remarks:
Skin corrosion (tissue destruction) was considered to have occurred if ulceration or necrosis was observed in any of the readings
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Remarks:
Skin corrosion (tissue destruction) was considered to have occurred if ulceration or necrosis was observed in any of the readings
Irritant / corrosive response data:
Skin necrosis was visible in both rabbits at 4 and 48 hours after application of the test article.

Any other information on results incl. tables

Skin necrosis was visible in both rabbits at 4 and 48 hours after application of the test article.

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
Based upon the results of the DOT Corrosivity Study in Rabbits, the test substance was considered to be corrosive.