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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: red granulate
Details on test material:
Content: at least 97 %

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 6 month
- Weight at study initiation: ca 3 kg
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: moistened with water
Controls:
other: the oposite flank served as control
Amount / concentration applied:
500 mg pulverised substance
Duration of treatment / exposure:
4 h
Observation period:
Up to 72 hours because no effects were observed up to then.
Number of animals:
3 females
Details on study design:
Approximately 24 hours before the test, the fur was removed by shaving from the dorsal area of the trunk of the animal . Only animals with health intact skin were used. A dose of 500 mg was applied to the test site and were moistened sufficiently with water to ensure good contact with the skin. The test site was then covered with a gauze patch. The patch was held in contact with the skin by means of semi-occlusive dressing for the duration of the exposure period. The surrounding untreated skin served as a control. exposure time was 4 hours. After termination the exposure period the coverage was removed and . the skin sites were evaluated for erythema and edema. scores according to Draize were taken 60 min., 24. 48, and 72 hours after patch removal .

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 60 min, 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: no erythema was observed
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 60 min, 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: no edema was observed
Irritant / corrosive response data:
No effects were observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No erythema (E) and no oedema (Oe) was observed after 60 min., 24 h, 48 h and 72 h.
Executive summary:

According to OECD TG 404 and GLP 3 female Himalayan rabbits received dermal application on the shaved back for 4 hours held in place by semi-occlusive dressing, 60 min, 24, 28, and 72 hours after removal of the dressing the treated area was examined and the effects scored according to Draize. None of the animals showed erythema or edema. Therefore the compound was evaluated to be non-irritating to the skin of rabbits.