416-730-1

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline conform

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

observation period 4d only

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

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 3.0 to 3.2 kg and approximately 13 to 14 weeks of age, prior to treatment (Day 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. 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 examination of drinking water at source as conducted usually weekly by the supplier, are made available to Huntingdon Research Centre Ltd. as quarterly sununaries.
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 label 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:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

0,5 g in 0,5 ml distilled water

Duration of treatment / exposure:

4h

Observation period:

4d

Number of animals:

3

Details on study design:

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.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 2 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Irritant / corrosive response data:

Very slight erythema with or without very slight oedema was seen in all three animals on Day 1 only (score 1). All reactions has resolved by day 2.

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 irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A single semi-occlusive application of the test substance to intact rabbit skin for four hours elicited transient very slight dermal reactions.

Executive summary:

Three rabbits were each administered a single dermal dose of 0.5 g of the test substance and observed for four days.

A single semi-occlusive application of the test substance to intact rabbit skin for four hours elicited transient very slight dermal reactions. All reactions had resolved by Day 2.