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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:
22-November-2001 to 26-November 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in 2002 according to OECD Method 404 and EU Annex V test B4and in accordance with GLP. Study material is well characterized.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according 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:
Test material is a extremely light tan colored powder which was received at testing laboratory on 24 October 2001 and stored at room temperature in the dark.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
At the start of the study the rabbits weighed 2.0 to 3.5 kg and were twelve to sixteen weeks old. Free access to mains drinking water and food was allowed through out the study. The temperature and relative humidity were set to achieve limits of 17 to 23 C and 30 to 70% respectively. The rate of air exchange was at least 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours of darkness.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other:
Controls:
not required
Amount / concentration applied:
0.5 g of the test material, moistened with 0.5 ml of distilled water was introduced under 2.5 cm X 2.5 cm cotton gauze patch
Duration of treatment / exposure:
4 hours after treatment.
Observation period:
Approximately one hour after removing the patch and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored.
Number of animals:
3
Details on study design:
The day before the test the three rabbits were clipped free of fur from the dorsal/flank area and inspected for gross abnormalities of the epidermis. Only animals with an intact healthy epidermis are selected for the study. Initially only one animal was treated with three sites on the back of the rabbit selected. At each test site 0.5 g of test material moistened with 0.5 ml of distilled water was introduced under a 2.5 cm X 2.5 cm cotton gauze patch which was secured in position with surgical tape. The animal was then placed in a corset to avoid the rabbit interfering with the patch and one patch removed at each of 3 times: 3 minute, 1 hour, and 4 hours. After review of skin irritations for the first rabbit, 2 additional rabbits were treated and then 4 hours later the patches were removed. The test sites were ten evaluated after 1 hour, 24, 48, and 72 hours according to the Draize classification scheme for determination of primary irritation index.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: at end of observation period
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: at end of observation period
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
The individual scores for erythema/eschar and oedema were all zero for all three animals for the complete 72 hour observation period. No evidence of skin irritation was noted during the study.The Draize classification scheme for determination of primary irritation index was used.
Other effects:
No evidence of skin irritation was noted during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a primary irritation index of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. The test material did not meet the classification as irritant or corrosive according to the EU labelling regulations.
Executive summary:

Studies were assigned reliability of 1 and followed acceptable OECD, EU or recognised standards and were in accordance with GLP. The test material produced a primary irritation index of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.