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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: comparable to guideline study with acceptable restrictions (e.g. rel. low purity of test substance 86.3%)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: 84/449/EWG, B.4
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 86.3%, date of manufacture: Nov. 19, 1991

Test animals

Species:
rabbit
Strain:
other: Small white Russians, Chbb: HM, SPF
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach
- Age at study initiation:
- Weight at study initiation: healthy, adult animals 2-3 kg
- Housing: animals were kept individually in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 14 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr):
- Photoperiod: artificial light, 12 hours light/dark cylce


I

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Moistening of the surface with completely deionized water.
Controls:
not required
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2, covered with gauze
- % coverage:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm water
- Time after start of exposure:up to 72 h


SCORING SYSTEM:

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
Reversibility:
other: score = 0 at any time point
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Other effects:
No skin irritations were observed.

Any other information on results incl. tables

The study showed that dermal application of 0.5 g of the solid test substance, while being wetted with completely de-ionized water, to three animals for 4 hours under semi-occlusive conditions did not lead to any skin irritations.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No skin irritations were observed after application of the test substance to 3 animals for 4 hours.
Executive summary:

In a OECD Guideline study (404) with rabbits, the dermal application of 0.5 g of the solid test substance to three animals for 4 hours did not lead to any skin irritations (Hüls AG 1992c).