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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Principles of method if other than guideline:
500 mg Cohedur RK (= m-phenylene di(acetate)) were semiocclusively applied once to the intact skin (ear) of two young adult New Zealand white rabbits (3.0–4.0 kg) for an exposure period of 24 hours. Evaluation of skin irritation was made until day 7 according to Draize.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
24 hours.
Observation period:
7 days
Number of animals:
2 animals
Details on study design:
After 24 hours the test material was removed with water and soap.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritant / corrosive response data:
Erythema and edema score = 0 at 24/48/72 hours.

Any other information on results incl. tables

Cohedur RK (= m-phenylene di(acetate)) was not irritating under the condition of the test (Erythema and edema score = 0 at 24/48/72 hours).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Cohedur RK (= m-phenylene di(acetate)) was not irritating under the condition of the test (Erythema and edema score = 0 at 24/48/72 hours).
Executive summary:

500 mg Cohedur RK (= m-phenylene di(acetate)) were semiocclusively applied once to the intact skin (ear) of two young adult New Zealand white rabbits (3.0–4.0 kg) for an exposure period of 24 hours. Evaluation of skin irritation was made until day 7 according to Draize. Erythema and edema score was 0 at 24/48/72 hours.