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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:
January 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Froxfield (UK)
- Age at study initiation: 13-19 weeks if age
- Weight at study initiation: 2.9-3.9 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: yes but no details

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:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5 g of the test substance was applied under a 25 mm x 25 mm gauze pad moistened with 0.5 ml distilled water to one intact skin site of each animal
Duration of treatment / exposure:
4 hours
Observation period:
4 days
Number of animals:
3
Details on study design:
The test substance was administered following grinding using a pestle and mortar.
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.
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°C to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
All animals were observed daily for signs of ill health or toxicity.
Dermal examination of the treated skin was made on Day 1 (60 minutes after removal of the dressings) and on Days 2, 3, and 4 (equivalent to 24, 48 and 72 hours after exposure).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No dermal irritation was observed at 60 min, 24h, 48h and 72h after patch removal.
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:
GHS criteria not met
Remarks:
: Not skin irritating
Conclusions:
A single semi-occlusive application of the test substance to intact rabbit skin for 4h elicited no dermal irritation.
Executive summary:

A study was performed to assess the skin irritation potential of the test item to the rabbit. Three rabbits were each administered a single dermal dose of 0.5 g of the test substance and observed for four days. No dermal reactions were observed following a single semi-occlusive dermal application of the test substance to intact rabbit skin for four hours. Based on these results, the test substance is considered as not skin irritating.