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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:
Aug 5, 1988 to Aug 8, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1988
Reference Type:
publication
Title:
The appraisal of chemicals in foods, drugs and cosmetics
Author:
Draize, J
Year:
1959
Bibliographic source:
Association of Food and Drug Officieals of the United States, pp 36-45
Reference Type:
publication
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test material was the commercial product.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Separate isolation by test system. Light cycle: 12 hr light, 12 hr dark. Temperature/humidity: maintained at 22°C ± 3°C and 30 to 70% humidity. Housed individually in cages sized in accordance with “Guide for the Care and Use of Laboratory Animals” of the Institute of Laboratory Resources, National Research Council. Waste material removed twice weekly. Cages and feeder sanitized every 2 weeks. Wayne Rabbit Ration, ad libitum, checked daily and added or replaced as needed. Fresh tap water ad libitum.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped free of hair
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
500 mg/site
Duration of treatment / exposure:
4 hr
Observation period:
30-60 minutes, 24, 48 and 72 hours
Number of animals:
3M/3F
Details on study design:
Scoring according to Draize 1959

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 30-60 minutes
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 30-60 minutes
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hr
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hr
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hr
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicabl
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicabl
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicabl
Irritant / corrosive response data:
No erythema or edema was detected at any time point in any animal.
Other effects:
None observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The material is not a skin irritant.
Executive summary:

The test article (500 mg/site) was applied to one intact skin site on each of six New Zealand White rabbits (3 males and 3 females). The test article was administered once and remained in contact with the skin for 4 hours. The skin was observed for erythema and edema and scored according to the Draize Score at 30 to 60 minutes, 24, 48 and 72 hours after application of the test article. No signs of erythema or edema were observed throughout the 72 hour observation period in any of the animals on test. The test article was not a dermal irritant.