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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Source study has reliability 1. Details on the read across are attached in section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

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:
not specified

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:
Body weight: 2.7 - 2.8 kg
Room temperature: 19-25 °C
Relative humidity: 40-60 %
Light period: 12 h light/12 h dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes
Amount / concentration applied:
0.5 g of test substance paste
Duration of treatment / exposure:
4 h, after which the test sites were washed
Observation period:
72 h; the skin was checked for irritation (erythema, eschar, oedema) and corrosion (ulcerations, necrosis, scarring) after 24, 48 and 72 h
Number of animals:
3
Details on study design:
Approximately 24 h before the test, the fur was shaved from the dorso-lateral area of the trunk (6 × 6 cm). 500 mg of the pulverized test substance were moistened with water and subsequently applied to a hypoallergenic patch (2.5 × 2.5 cm). Patches were held in place with semi-occlusive dressing for 4 h.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of erythema, eschar and oedema or ulcerations, necrosis, and scarring were observed.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritant to rabbit skin.
Executive summary:

Method

Study conducted according to OECD guideline 404 and EU method B.4, using female New Zealand White rabbits exposed for 4 h to 0.5 g of test substance (paste with water).

Test site was shaved and the type of coverage applied was semi-occlusive. After 4 h, the skin was washed with water. Skin sites were checked for irritation (Draize scores - erythema, eschar, oedema) and corrosion (ulcerations, necrosis, scarring) after 24, 48 and 72 h.

Results

No signs of skin irritation or corrosion were observed during the study. Test substance was not irritant to rabbit skin.