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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:
19 through 22 April 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in accordance with a recognised test guideline (US Federal Register), and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Unifoam AZ SO-NL
- Substance type: yellow powder
- Physical state: solid
- Analytical purity: 100%
- Stability under test conditions: Not reported.
- Storage condition of test material: ambient temperature, in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Buckmasters, Henham, Hertfordshire, ENGLAND
- Age at study initiation: ten to thirteen weeks
- Weight at study initiation: 2.4 to 2.9 kg
- Housing: individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): SDS Standard Rabbit Diet ad libitum
- Water: ad libitum
- Acclimation period:yes, but period not specified.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light):12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: 24 hours prior to treatment, hair was removed with clippers
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.5 g and 0.5 ml distilled water
Duration of treatment / exposure:
4 hours
Observation period:
Day 1 (30 minutes after removal of patches) and on Days 2, 3, and 4.
Number of animals:
6 males
Details on study design:
TEST SITE
- Area of exposure: Hair was removed (clipped) from an area 10 cm square; test substance was applied under a gauze pad 2.5 cm square.
- % coverage:
- Type of wrap if used: elastoplast

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: four hours


SCORING 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) 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

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4 days
Score:
0
Max. score:
0
Remarks on result:
other: no effects seen to any animal
Irritant / corrosive response data:
The numerical scores awarded to the dermal reactions elicted by Unifoam AZ SO-NL are all zero out of four at each observation point, for each animal.

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 Unifoam AZ SO-NL to intact rabbit skin for four hours elicited no dermal irritation.
Executive summary:

A dermal irritation test was performed to assess the irritation to skin caused by the test substance AZ SO-NL (HLS 1988, OCI66/88554D). The study was conducted according to official test guidelines, and in compliance with GLP.

0.5 g of test substance was applied to the skin of six albino rabbits and held in place with a semiocclusive dressing for four hours. At the end of the exposure period, the test substance was washed off with water. The treatment site was observed on days 1 (approximately 30 minutes after removal of the test substance), 2, 3, and 4.

None of the animals showed any response to treatment.

A single semi-occlusive application of AZ SO-NL to intact rabbit skin for four hours elicited no dermal irritation.