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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:
June 28 to July 1, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline test with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
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: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Identity : BM1-resin
Lot number / Batch number: 5003-2
Expiry : January 1996
Composition: > 98 % Epoxide resin based on Bisphenol A and epichlorohydrin, blocked with paraphenyl phenol
Appearance: Yellowish powder
Storage conditions: Room temperature
Date received: 9 June 1994





Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
ANIMAL MANAGEMENT
Three healthy adult rabbits of the New Zealand White strain were obtained from Froxfield (U.K.) Ltd., Petersfield, Hampshire, England.
They were in the weight range of 2.3 to 2.6 kg and approximately 10 to 12 weeks of age, prior to treatment @ay 1). All rabbits were acclimatised to the experimental environment.
The rabbits were selected without conscious bias for the study. They were housed individually in plastic cages with perforated floors in Building R 14 Room 1. A standard laboratory diet SDS Stanrab (P) Rabbit Diet and drinking water were provided ad libitum. The batch of diet used for the study was not analysed for nutrients, contaminants or micro-organisms. Results of routine chemical exarnination of drinking water at source as conducted usually weekly by the supplier, are made available to Huntingdon Research Centre Ltd. as quarterly sumrnaries.
Animal room temperature was maintained at approximately 19°C and relative humidity at 30 - 70%. These environmental Parameters were recorded daily. Air exchange was maintained at approximately 19 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.
Each animal was identified by a numbered aluminium tag placed through the edge of one ear. This number was unique within the HRC Industrial Toxicology Department throughout the duration of the study. Each cage was identified by a coloured labe1 displaying the study schedule number, animal number and initials of the Study Director and Home Office licensee.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral skin
Amount / concentration applied:
Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 100 mm X 100 mm.
A 0.5 g amount of the test substance was applied under a 25 mm X 25 mm gauze pad which had been moistened with 0.5 ml distilled water to one intact skin site on each animal.
Each treatment site was covered with "Elastoplast" elastic adhesive dressing for four hours. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment.
At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (30" to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent Paper.
Duration of treatment / exposure:
4 hours
Observation period:
on Day 1 (i.e. approximately 60 minutes after removal of the dressings) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure).
Number of animals:
3
Details on study design:
Ciinical signs
All animals were observed daily for signs of ill health or toxicity.
Examination of the treated skin was made on Day 1 (i.e. approximately 60 minutes after removal of the dressings) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure).
Local dermal irritation was assessed using the prescribed numerical system:
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)
preventing erythema reading 4
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending
beyond the area of exposure) 4
Any other lesion not covered by this scoring system, was described.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Day 1 (i.e. approximately 60 minutes after removal of the dressings) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure).
Score:
0
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
8
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
8
Irritant / corrosive response data:
No dermal response to treatment was observed in any animal throughout the observation period.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A single semi-occlusive application of test substance to intact rabbit skin for four hours revealed no dermal irritation and can therefore be considered to be non-irritant to rabbit's skin under the results described in this report.
Executive summary:

This study was performed to assess the skin irritation potential of test substance to the rabbit. The method followed was that described in OECD Guideline for Testing of Chemicals No. 404. Three rabbits were each administered a single dermal dose of 0.5 g of the test substance and observed for four days. No reactions were observed following a single semi-occlusive application of test substance to intact rabbit skin for four hours. Test article can therefore be considered to be non-irritant.