Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
other: Guideline study under GLP conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

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: yellow powder
Details on test material:
content: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: females 2.8-3.5 kg
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 /12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite side of the flank served as control
Amount / concentration applied:
500 mg moistened with water
Duration of treatment / exposure:
4 h
Observation period:
planed up to 14 days but terminated after 7 d because up to then no effects were observed
Number of animals:
3
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 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 opposite 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 24. 48, and 72 hours after patch removal for erythema and edema formation

Results and discussion

In vivo

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

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
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 hiours 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 theMacrolex Gelb G was evaluated to be non-irritating to the skin of rabbits.