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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:
1985
Reliability:
2 (reliable with restrictions)
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
TK 10884/1, batch-no. EP 760/4.10.84, XB 5023

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
3 male rabbits, weighing 2 - 3 kg (12 - 14 weeks old), were individually housed in metal cages, identified with ear tags, and kept at constant temperature of 20 +/- 3 °C, a relative humidity of 30-70% and at a 12 hour dark/light cycle. m They received diet and water ad libitum Body weight was recorded on days 0, 3, and 7 of the test.

Test system

Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 grams per flank of 6 cm2
Duration of treatment / exposure:
4 hours with a semi-occlusive bandage
Observation period:
Observation was daily.
Skin reactions and signs of toxicity were recorded at 1 hour, 24, 48, 72 hours , and daily afterwards,
Number of animals:
three male rabbits
Details on study design:
Irritation / corrosion was classified according to EEC guideline 83/467/1983 (Appendix 2).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
> 0.3 - < 0.4
Max. score:
4
Reversibility:
fully reversible within: after 7 days
Remarks on result:
other: max. score = 4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
> 0.3 - < 0.4
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: max. score = 4
Irritant / corrosive response data:
The resposnses were mild and the average from 3 animals was lower than minimum for classification and labelling
Other effects:
Body weight development was not adversely affected by the treatment

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Although there was erythema in 2/3 animals and oedema in 1/3 animals with a minimum score of 1, the mean value was below the threshold for classificaiton and labelling
Executive summary:

Although there was erythema in 2/3 animals and oedema in 1/3 animals with a minimum score of 1, the mean value was below the threshold for classification and labelling; the product TK 10884/1 is minimally irritating to skin