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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
Study period:
December 20, 1994 - January 3, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farm, South Brunswick, NJ
- Housing: individually housing in in suspended stainless steel caging with mesh floors
- Diet: Pelleted Purina Rabbit Chow #5326
- Water: ad libitum (tap water)
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 - 22.2
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: The area of exposure was covered with a 2 1/4 x 3" adhesive-backed gauze patch and then wrapped with 3" Micropore tape.

REMOVAL OF TEST SUBSTANCE
- Washing: Yes
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
Skin reactions were scored at 1 hour, 24, 48 and 72 hours and 7, 10 and 14 days after patch removal.

SCORING SYSTEM:
- Method of calculation: according to Draize scoring

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.6
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.6
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.6
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
One hour after patch removal, well defined to moderate erythema and edema ware noted at all treated sites. Overall, The incidence and severity of irritation decreased with time. Although desquamation was evident at all sites between days 7 and 14, five of six animals were free from erythema and edema on day 14. Barely perceptible erythema remained at one site.
Other effects:
- Other adverse systemic effects: All animals appeared active and healthy. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behavior.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The test item is considered to be irritating to rabbits' skin as shown in a primary skin irritation study.
Executive summary:

A Primary Skin Irritation test was conducted with rabbits to determine the potential for the test item to produce irritation and/or corrosion after topical application. Five hundred milligram of the test substance was applied to the skin of six healthy rabbits for 4 hours. Following exposure, dermal irritation was evaluated by the method of Draize et al.

One hour after patch removal well defined to moderate erythema and edema were noted at all treated sites. Overall, the incidence and severity of irritation decreased with time.

The animals' individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema were 2.6, 2.0, 2.0, 2.3, 2.3 and 2.0, respectively. The animals' individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for edema were 3.0, 3.0, 2.6, 2.6, 2.0 and 2.3, respectively. Although desquamation was evident at all sites between days 7 and 14, five of six animals were free from erythema and edema on day 14. Barely perceptible erythema remained at one site. All animals appeared active and healthy. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behavior.

Based on the results of testing, the test substance is considered to be irritating to rabbits‘ skin.