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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:
other: scientifically acceptable and sufficiently documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Principles of method if other than guideline:
2 animals, application inside rabbit ear, exposure period 24 h, dose 500 mg/animal, post exposure period 7 days.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No further data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
white New Zealand rabbits, weight 3 to 4 kg

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
water
Controls:
other: the oposite ear served as control
Amount / concentration applied:
amount: 500 mg
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
2
Details on study design:
2 rabbits, application of 500 mg/animal moistened with water, at the inside of one ear of each of the 2 rabbits ( the other ear served as control), and fixed with a plaster for the exposure period of 24 h, then the skin was washed with water and soap, postexposure period 7 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 0 h, 2 and 7 d
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 0 h, 2 and 7 d
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 0 hours
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 0 hours
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
>= 0
Max. score:
4
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
>= 0
Max. score:
4
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
4
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
4
Remarks on result:
not measured/tested
Irritant / corrosive response data:
According to the available data the substance is not irritating
Other effects:
no data

Any other information on results incl. tables

According to the available data the substance is not irritating.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

Application of 500 mg Trimethylolpropane/rabbit on the inner surface of one rabbit's ear of each of the 2 rabbits (the other one served as control) for 24 hours followed by a 7-day-observation period, does not result in irritational effects at any time point (Bayer AG 1979).