Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf/Switzerland
- Age at study initiation: 15 to 16 weeks
- Weight at study initiation: 2.5 to 2.6 kg
- Housing: Housed individually in stainless steel cages
- Diet (e.g. ad libitum): Pelleted standard Kliba 341
- Water (e.g. ad libitum): Community tap mater
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40 to 70
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: Jun 6, 1986 To: Jun 13, 1986

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: Tap water and 2 to 3 drops of Tween 80
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- The test article was applied moistened with tap water and 2 to 3 drops of Tween 80
Duration of treatment / exposure:
4 hours
Observation period:
Up to 72 hours after the removal of the dressing
Number of animals:
1 male and 2 females
Details on study design:
TEST SITE
- % coverage: Coverage was 3.0 cm x 3.0 cm
- Type of wrap if used: Test article was applied to the intact skin of the shaved area and was covered with a patch of surgical gauze. The gauze was covered with aluminum foil and then covered with an occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Four hours after the application, the dressing was removed and the skin was flushed with luke warm tap water.
- Time after start of exposure: 4 hours

SCORING SYSTEM: The same scoring system as the one provided in the OECD guideline 404.
To classify the irritating property of the test article, the mean values of erythema / eschar as well as of edema formation were calculated for each individual, using the scores between 24 and 72 hours (EEC Council Directive 83/467/EEC, July 1983, Brussels/Belgium). The dermal irritation scores were evaluated in conjunction with the nature and reversibility or otherwise of the responses observed.

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
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
Erythema and edema scores of 0 were reported in all animals tested at 1, 24, 48, and 72 hours. No staining of the treated skin by pigment or coloring of the test article was observed. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.
Other effects:
No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred. No macroscopic organ examination was performed. The body weight gain of all rabbits was similar.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this experiment, the test article is considered to be not irritating to the rabbit skin.
Executive summary:

The primary skin irritation potential of the test substance was investigated in a GLP compliant study according to OECD test guideline 404. The test item (0.5 g) was moistened with tap water and 2 to 3 drops of Tween 80 and applied by topical occlusive application to the intact dorsal area of three young adult New Zealand White rabbits. The duration of treatment was four hours after which the test article was removed by washing with lukewarm water. The skin reaction was assessed at 1, 24, 48 and 72 hours intervals after the removal of the dressing, gauze patch and test article. The corrosive properties of the test article to and the color of the treated skin area were described and recorded. The observation was terminated 72 hours after application of the test article. To classify the irritating property of the test article, the mean values of erythema / eschar as well as of edema formation were calculated for each individual, using the scores between 24 and 72 hours. Erythema and edema scores of 0 were reported in all animals tested at 1, 24, 48, and 72 hours. No staining of the treated skin by pigment or coloring of the test article was observed. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin. No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred. No macroscopic organ examination was performed. The body weight gain of all rabbits was similar. Thus, the test item did not induce significant irreversible damage to the skin and is therefore not regarded as a skin irritant.