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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:
02-12-98 to 05-12-98
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Appearance: Off-white powder
- Storage condition of test material: At room temperature protected from light
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
Off-white solid
Batch number: 002
Purity: 99.55%

STABILITY AND STORAGE OF TEST MATERIAL
Storage conditions: room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Three New Zealand White rabbits supplied by David Percival Ltd, Moston,Sandbach, Cheshire, UK were used. At the start of the study the animals
weighed 2.82 to 3.03 kg and were twelve to sixteen weeks old. There was an acclimatisation period of five days. The animals were individually housed in suspended metal cages. Free access to mains drinking water and food was allowed throughout the study.The animal room was maintained at a temperature of 16 to 20'C and relative humidity of 43 to 54%. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Amount / concentration applied:
0.5g of the test material, moistened with 0.5 ml of distilled water
Duration of treatment / exposure:
Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
Observation period:
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation.
Number of animals:
Three New Zealand White rabbits
Details on study design:
On the day before the test each rabbit was clipped free of fur from the dorsal flank area using veterinary clippers. On the day of the test a suitable test site was selected on the back of each healthy rabbit. A quantity of 0.5g of the test material, moistened with 0.5 ml of distilled water, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period. Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water. Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
63 male
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect.
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
64 Male
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
65 Male
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The study validly concluded that the GHS criteria was not met. The test material, BMS 233101-01, produced a primary irritation index of 0.0 to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. The test material did not meet the criteria for classification as irritant or corrosive according to EU CLP labelling regulations. No symbol and risk phrase are required.