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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From July 18 to 27, 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Complete read-across justification is attached in section 13. Source study has reliability 1.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 14 weeks (males), 13 weeks (females)
- Weight at study initiation: 2.4 to 2.7 kg
- Housing: individually in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days under laboratory conditions, after health examination

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 45 - 70 %
- Air changes: 10 - 15 per h
- Photoperiod: 12 h light and 12 h dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g moistened with bi-distilled water
Duration of treatment / exposure:
4 hours.
Observation period:
Up to 72 hours after treatment.
Number of animals:
2 females and 1 male.
Details on study design:
TEST SITE
- Area of exposure: ca. 6 cm2
- Type of coverage: semi-occlusive
- Type of wrap: dressing wrapped around the abdomen and anchored with tape

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm tap water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS: 1h, 24 h, 48 h, 72 h

SCORING SYSTEM:
ERYTHEMA AND ESCHAR FORMATION
0 No erythema
1 Very slight erythema
2 Well-defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) or eschar formation (injuries in depth preventing erythema) reading

OEDEMA FORMATION
0 No oedema
1 Very slight oedema (barely perceptible)
2 Slight oedema (edges of area well-defined by definite raising)
3 Moderate oedema (edges raised approximately 1 mm)
4 Severe oedema (raised more than 1 mm and extending beyond the area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Other effects:
- Mortality/clinical signs: no clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
- Irritation: test article did not elicit any skin reactions at the application site at any of the observation times (all scores 0). The mean values from 24 to 72 hours were therefore 0 for erythema and 0 for oedema.
- Coloration: no staining by the test item of the treated skin was observed.
- Corrosion: no irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
- Body weights: body weights of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
other: Non classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
Non irritant to the rabbits skin.
Executive summary:

Method

Skin irritation study carried out according to OECD guideline 404. Semicocclusive application of 0.5 g of test substance applied on clipped intact skin of 3 rabbits (2 F and 1 M) for 4 hours. Treated skin was washed and observed for signs of oedema and erythema at 1 h, 24 h, 48 h and 72 h.

Results

No signs of skin irritation and no staining were noted.