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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:
April - May 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Physical state: see above
- Appearance: see above
Specific details on test material used for the study:
TEST MATERIAL
- Substance identification/name in the report: P5256
- Aspect: off-white crystalline solid
- Batch no.: E 29.3.83

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage conditions: Room temperature, protected from light
- Stability under test conditions: stable
- Expiry date: not given

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bantin and Kingman Ltd., The Field Station, Grimston, Aldbrough, Hull, HUll 4QE
- Age at study initiation: young adult rabbits, exact age not given
- Weight at study initiation: 2.57 - 2.84 kg
- Housing: individually housed in grid floor cages
- Diet (e.g. ad libitum): Standard Rabbit Diet, Special Diets Services Ltd., Stepfield, Witham, Essex
- Water (e.g. ad libitum): mains water
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 20°C
- Humidity (%): 47 - 65%
- Air changes (per hr): single air conditioned room
- Photoperiod (hrs dark / hrs light): onstant daily photoperiod of 14 hours artificial light (06.00 - 20.00) and 10 hours darkness

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
0.5 g test item
Duration of treatment / exposure:
4 hours
Observation period:
24, 48 and 72 hours
Number of animals:
3 animals
Details on study design:
TREATMENT PROCEDURE:
The back of each animal was clipped free of hair the day prior to treatment using electric veterinary clippers (Model A2, Oster, Milwaukee, Wisconsin). A portion of test article (0.5 g moistened with a few drops of distilled water) was applied to an area of skin approximately 6 cm2 on each animal and covered with a gauze patch. The patch was occluded and secured using a strip of impermeable adhesive tape (Sleek, Smith & Nephew, Welwyn Garden City, Herts.). A plastic collar was placed around the neck of each animal to prevent premature removal of the wrappings and ingestion of the test article. Four hours after application the patches were removed and the skin wiped with a disposable paper towel moistened with ater to remove any test article still remaining.

EVALUATION OF EFFECTS:
One hour after removal of the wrappings the skin reactions were scored using the Draize scale. The evaluation was repeated 24, 48 and 72 hours after removal of the patches.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Slight erythema was noted in one animal at the 1 hour reading, but this animal was normal at the 24 hour observation. All other animals were normal over the whole 72 hour observation period. A primary irritation index of 0.0 was obtained. No corrosive effects were noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Slight erythema was noted in one animal at the 1 hour reading, but this animal was normal at the 24 hour observation. All other animals were normal over the whole 72 hour observation period. A primary irritation index of 0.0 was obtained. Th test item was regarded as a non-irritant to rabbit skin. No corrosive effects were noted.
Executive summary:

A study was carried out according to test methods EC B.4 and OECD 404 to determine the primary skin irritation index and corrosive effects of the test item in the New Zealand White rabbit. 0.5 g test item, moistened with water, was applied to hair free clipped skin of three female rabbits. Duration of treatment was 4 hours, observation period 24, 48 and 72 hours.

A single 4 -hour application produced a primary irritation index of 0.0. The test item was classified as a non-irritant to rabbit skin. No corrosive effects were noted.