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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:
15/02/2000 - 17/02/2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The observation time was 48 hours instead of the recommended 72.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: U.S. Food and Drug Administration regulations, 40 CFR, Part 792
Principles of method if other than guideline:
Current OECD TG 404 would necessitate readings up to 72 hours after the application of the test material. In the current study observations were made only up to 48 hours.
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
- Source: Milbrook Breeding Labs, Amherst, MA
- Age at study initiation: at least 10 weeks old
- Weight at study initiation: 2.03 - 2.1 kg
- Housing: individually housed
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 15
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml


Duration of treatment / exposure:
Single application for 3 minutes, 60 minutes and 4 hours.
Observation period:
Observations for visible necrosis were made at 30 - 60 minutes and again at 48 hours after bandage removal.
Number of animals:
3M, 3F
Details on study design:
TEST SITE
- Area of exposure: The trunk of the animal, three application sites.
- % coverage: Not less than 10%.
- Type of wrap if used: 'impervious bandaging'

REMOVAL OF TEST SUBSTANCE
- Washing (if done): USP Sterile water for injection.
- Time after start of exposure: After initial reading.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 3 minutes, 30-60 minutes and 48 hours
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Since there was no significant irritation at three minutes and one hour, the test substance was applied for a period of 4 hours. No erythema or oedema was noted in any of the test sites for the duration of the study. No corrosive effect was noted.
Other effects:
No overt signs of toxicity were evident in any of the animals during the course of the study. All of the animals exhibited a gain in body weight during the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was found not irritating in a study conducted according to current guideline and in compliance with GLP.