Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles and is acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Off-white powder
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Boyertown, PA
- Age at study initiation: 4 - 5 months
- Weight at study initiation: 2.0 - 2.4 kg
- Housing: 1/cage in suspended wire cages. Bedding was placed beneath the cages and changed at least three times per week.
- Diet: Fresh Purina Rabbit Chow (Diet #5321) was provided daily
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: controlled
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g/rabbit
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6 females
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: 2.5 x 2.5 cm surgical gauze patch; the patch was secured with non-irritating tape. The torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape which completely covered the plastic.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test article was removed from the test site by gentle washing with distilled water at the end of the exposure period, prior to scoring for dermal reactions
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to the Draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Remarks on result:
other: Erythema with max. score of 1 in two animals was noted at 60 min time point, reversible within 24 hours.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
In two animals, slight erythemas (score = 1) were noted 30 - 60 minutes after patch removal and cleared by 24 hours. Edema was absent at all observation intervals.
Other effects:
There were no abnormal systemic signs noted during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The test article caused only minimal skin reactions in 2/6 animals and is therefore considered to be not irritating to the rabbit skin.
Executive summary:

In a primary dermal irritation study according to OECD guideline 404, six female New Zealand White rabbits were dermally exposed to the test item for four hours in a semi-occlusive manner. 0.5 g of the test substance was placed on a clipped but intact area of the torso and held in place by a gauze patch moistened with distilled water. After 4 hours the wrappings were removed and residual test article was removed from the test site by gentle washing with distilled water. Dermal reactions were then scored according to the Draize scoring system at 30-60 min, 24, 48 and 72 hours after removal of the test substance. Only minimal erythema reactions were observed in two animals, reversible within 24 hours. All other scores for erythema and edema were zero. There were no abnormal systemic signs noted during the observation period. Therefore, based on this result, the test substance is considered to be not irritating to the rabbit skin.