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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: acceptable, well-documented publication which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity >99.5%

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
The animals were identified via ear tattoo. The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 - 24°C for temperature and of 30 - 70% for relative humidity. There were no deviations from these ranges which influenced the results of the study.
No bedding were used (saw-dust in the waste trays). Diet was Kliba 341 and drinking water was about 250 ml per animals and day. The acclimatization period was at least 8 days before beginning of the study with the same housing conditions as during the test period.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
Clipping of the fur was at least 15 h before the beginning of the study. The application site was the upper third of the back or flanks. Removal of the test substance: at the end of the exposure period with Lutrol and Lutrol/water (1:1). The observation period was 72 h and readings were done 30 - 60 min after removal of the test patches and 24, 48, 72 h after the beginning of the application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-27 h
Score:
0
Max. score:
0

Any other information on results incl. tables

Very slight to well-defined redness was observed 4 hours after application. These effects were reversible within 24 h. No effects on edema. One animal died after 72 h after application. This death was not substance-related.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information