Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-12-12 to 1992-02-19
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline Study (OECD 404 adopted 1981), GLP compliant. Acceptable deviations from OECD Guideline 404 adopted 2002: occlusive treatment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1981
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS AND ENVIRONMENTAL CONDITIONS
- Source: Dr. K. Thomae GMBH; Chemisch-pharmazeutische Fabrik; D-7 950 Biberach/Riss;
- Acclimatisation: at least 5 days;
- Weight: 2410 to 2660 g
- Housing: the animals were housed individually in metal cages, identified by ear tattoo
- Temperature: 20 +/- 3 °C
- Humidity: 30-70 %
- Photoperiod: 12 hours light cycle day
- Diet: rabbits received ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland - and fresh water.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80.
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
72 hours (reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches )
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: An area of at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment.
- Coverage: A gauze patch (approx. 12-16 cm² ) bearing 0.5 g of the test article was applied to the right flank of each animal. A control gauze patch was applied to the contralateral flank. Both patches were moistened before application with 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80.
- Type of wrap: The patches were loosely covered with an aluminum foil (approx. 36 cm² ) and held in place for 4 hours by an adhesive tape.

SCORING SYSTEM
According to the OECD scoring system.

OTHER
The animals were checked daily for systemic symptoms and mortality.
The bodyweight was recorded at start and on day 3 of the test.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
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
Irritant / corrosive response data:
No skin reactions were noted.
Other effects:
One hour after patch removal the application area was stained with the dark red test article.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information