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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
not given in the report

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.2-3.3 kg
- Housing: individually
- Diet ad libitum:
- Water ad libitum
- Acclimation period: at least 14 dqys

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20
- Humidity (%):50
- Air changes (per hr):10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite side of the back served as control
Amount / concentration applied:
500 µl
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
500 µl was applied to the shaved back of each of 3 rabbits and covered by semi-occlusive dressing. The exposure time was 4 hours. The opposite side of the back served as control. After removing of the dressing the treated area was carefully washed. The observation period lasted 14 days. The area were evaluated according to prescription of the guideline.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hour - 14 days
Score:
ca. 0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1h - 14 d
Score:
ca. 0
Max. score:
4
Irritant / corrosive response data:
the above results show that the test compound can be regarded as not irritating to the skin

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Skin irritation test was performed according to OECDTG 404 and GLP: 500 µl was applied to the shaved back of each of 3 rabbits and covered by semi-occlusive dressing. The exposure time was 4 hours.The opposite side of the back served as control. After removing of the dressing the treated area was carefully washed. The observation period lasted 14 days. The area were evaluated according to prescription of the guideline. No erythema(score0 of mac 4) or edema (score 0 of max 4) were observed in none of the 3 rabbits. Therefore, the test compound can be evaluated as not irritating to the skin. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
Executive summary:

Skin irritation test was performed according to OECDTG 404 and GLP: 500 µl was applied to the shaved back of each of 3 rabbits and covered by semi-occlusive dressing. The exposure time was 4 hours.The opposite side of the back served as control. After removing of the dressing the treated area was carefully washed. The observation period lasted 14 days. The area were evaluated according to prescription of the guideline. No erythema(score0 of mac 4) or edema (score 0 of max 4) were observed in none of the 3 rabbits. Therefore, the test compound can be evaluated as not irritating to the skin. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.