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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
1 males and 2 females
- Body weight at start of acclimatization: 2.9 kg (male) and 2.6-2.8 kg (females)
- Body weight at start of treatment: 3.2 kg (male) and 2.8-3.1 kg (females)
- Age at treatment: 15 weeks
- Acclimatization: 4 days under test conditions after health examination
- Accomodation: individually in stainless steel cages with an automatic cleaning system, equipped with feed hoppers, drinking water bowls and wood for gnawing- Diet: pelleted standard Kliba 341 rabbit maintenance diet (batch 94/96) ad libitum from Kliba Mühlen AG, CH-4303 Kaiseraugst
- Water: community tap water from Itingen, ad libitum
- Standard laboratory conditions: Air-conditioned with 10-15 air changes per hour and continuously monitored environment with target ranges for temperature of 20 ± 3 °C and for relative humidity between
40-70 % (values above 70 % during cleaning process possible), 12 hours artificial fluorescent light/12hours dark, music during the light period.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
bi-distilled
Amount / concentration applied:
0.5 g of test substance
Duration of treatment / exposure:
4 hours of application
Observation period:
72 hours
Number of animals:
3 (1 male and 2 females)
Details on study design:
TREATMENT
Approximately 24 hours before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). The skin of the animals was examined once, 1 day prior to test substance administration.Only those animals with no signs of skin injury or irritation were used in the test.On the day of treatment, 0.5 g of the test article was applied to approx. 6 cm2 of the intact skin of the clipped area. It was covered with a 2.5 cm x 2.5 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. The test substance was applied in such a position as to preclude oral ingestion after removal of the dressing.The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.

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
Edema Formation
No edema: 0
Very slight edema (barely perceptible): 1
Slight edema (edges of area well defined by definite raising): 2
Moderate edema (raised approximately 1 mm): 3
Severe edema (raised more than 1 mm and extending beyond area of exposure): 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: all animals (3/3)
Time point:
72 h
Score:
0
Remarks on result:
not determinable
Remarks:
after 24 and 48 h the evaluation of some parameters was precluded due to staining.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
edema score
Basis:
animal: all animals (3/3)
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
The substance showed a primary irritation score of 0 when applied to healthy intact rabbit skin.Local signs (mean values from 24 to 72 hours) consisted of grade 0 erythema and grade 0 edema.
Blue or dark blue staining by the test article of the treated skin was observed.
No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.The body weight gain of all rabbits was within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation
Conclusions:
The test substance was found to be non irritant when applied to intact rabbit skin.
Executive summary:

The skin irritation test was performed to rabbit skin according to the OECD guideline 404.

The test substance was found to be non irritant when applied to intact rabbit skin: local signs (mean values from 24 to 72 hours) consisted of grade 0 erythema and grade 0 edema. The test article caused blue or pale blue staining of the treated skin, therefore the erythema reaction could not be evaluated after 24 and 48 hours, nevertheless the possible score are not considered to be significant . No corrosive effects were noted on the treated skin of any animal at any measuring interval. 6