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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Reliability 4 has been assigned due to the lack of information on the composition of test substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Principles of method if other than guideline:
Based on: Federal Register 38 no. 187, 1550.41 (skin), S. 27019, 27.09.73
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rabbit
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: stainless steel cages without litter
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: > 3 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 h light / 12 h dark

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes
Amount / concentration applied:
0.5 g for solid substances at 50 % in water.
Duration of treatment / exposure:
24 h
Observation period:
After 24 h and 72 h. In case of findings at 72 h, additional reading after 7 d.
Number of animals:
6 per group.
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm × 2.5 cm
- Type of wrap if used: gauze, fixed by elastic bandage then PVC-film

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water or Lutrol 400 / water mixture.
- Time after start of exposure: 24 h

SCORING SYSTEM:
Erythema and eschar formation
0 no erythema
1 very slight erythema (barely perceptible)
2 well defined erythema
3 moderate to severe erythema
4 severe erythema (beef redness) to slight eschar formation (injuries in depth)

Edema formation
0 no edema
1 very slight edema (barely perceptible)
2 slight edema (edges of area well defined by definite raising)
3 moderate edema (raised approximately 1 mm)
4 severe edema (raised more than 1 mm and extending beyond area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 h
Remarks on result:
not determinable
Remarks:
due to staining
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 h
Score:
0
Remarks on result:
no indication of irritation

Any other information on results incl. tables

rating grades time after application skin irritation
animal
1 2 3 4 5 6
erythema/eschar 24 * * * * * *
72 * * * * * *
oedema 24 0 0 0 0 0 0
72 0 0 0 0 0 0

Evaluation of erythema was not possible due to staining; no oedema formation occurred.

Applicant's summary and conclusion

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

Method

A study on 6 rabbits was conducted to assess skin irritation potential of test substance, by application of 0.5 g of test substance in water on clipped intact skin. Untreated skin served as control. After 24 h of exposure, skin was washed with water; assessment for erythema and oedema formation was carried out 24 and 72 h after removal according to Draize scale.

Results

Erythema could not be assessed due to staining; no signs of oedema were visible in any of the rabbits.