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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:
June 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Disperse Red 167:1

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
-Source: Mellor Rabbits, Chadderton Heights, Chadderton, Nr Oldham, Greater, Manchester, UK
-Age at study initiation: between 11 and 17 weeks
- Weight at study initiation: 2.14-2.71Kg
- Housing: individually in satinised aluminium sheet cages
- Diet: Labsure CR6 Rabbit Diet ad libidum
- Water: via an automatic system ad libidum

ENVIRONMENTAL CONDITIONS
- Temperature: 16-20°C
- Humidity: 43-80 %
- Photoperiod: 12 hours cycle dark/lights maintained at a temperature

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g, pasted with 0.4 mL of deionised water
Duration of treatment / exposure:
4 hours
Observation period:
examination after 30-60 minutes, 1, 2 and 3 days after removal
Number of animals:
3
Details on study design:
TEST SITE
- Preparation: about 24h before the start of the study the hair in the dorsal region on the body was removed with an electric clipped. Only animals with intact skin were used.
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: surgical gauze, covered by a piece of impermeable rubber sheeting, secured with adhesive impermeable polyethylene tape

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with warm tap water
- Time after start of exposure: after 4 hours

SCORING SYSTEM: according to the score of Draize (see table 1 in "Any other information on materials and methods incl. tables)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Time point:
24/48/72 h
Remarks on result:
not determinable
Remarks:
Erythema could not be assessed as the skin was stained red by the test material
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
At the end of the study the application sites were submitted for histopathological examination which revealed no obvious evidence of an inflammatory reaction. On the basis of the histopathological findings and the lack of oedematous reaction the test material is considered unlikely to be an irritant to rabbit skin.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions described for evaluation of the acute dermal irritation / corrosivity, the test item is detemined to be not irritating to the skin.
Executive summary:

In a dermal irritation study equivalent to OECD 404 with the test item, 3 young adult New Zealand White rabbits were dermally exposed to 0.5 g test item in water for 4 hours to approx. 6.25 square centimetres body surface area. Animals then were observed for 3 days. Irritation was scored by the method of Draize.

No signs of oedema were observed throughout the study. Erythema could not be assessed as the test item stained the skin red. At the end of the study the application sites were histopathological examined. There was no evidence of an occurred inflammation.

Based on these results, the test item is considered to be non-irritant according to CLP criteria.