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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:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Remarks:
testing lab.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 99.93%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
ldentification of the animals: Ear tattoo. Age at the beginning of the study: About 7 - 8 months. Body weight range at day 0: 3.82 kg - 4.00 kg
The animals were housed in fully air-conditioned rooms, in which a central air-conditioning system ensured a temperature in the range of 20 - 24°C and a relative humidity in the range of 30 - 70%. Illumination period: 12 h light (6.00 a.m. - 6.00 p.m.) / 12 h darkness (6.00 p.m. - 6.00 a.m.). No. of animals per cage: single housing. Type of diet: Kliba-Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 glanimal per day). Watering: Tap water ad libitum. Acclimatization period: At least 5 days before the beginning of the study.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipping of the dorsolateral part of the trunk
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
14 days
Number of animals:
4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 3 min
Score:
1.7
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 3 min
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 h
Score:
2.7
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 h
Score:
0.3
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 h
Score:
1.7
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 h
Score:
0

Any other information on results incl. tables

After the exposure period of 3 minutes slight to moderate erythema, partly extending beyond the area of exposure and slight edema were observed during the course of the study. Additionally dryness of the skin was noted. The average score (24 to 72 hours) for irritation was calculated to be 1.7 for erythema and 0.0 for edema. The cutaneous reactions (with the exception of dryness of the skin) were reversible in the animal within 7 days after removal of the patch. The exposure period of 1 hour caused slight to marked erythema, extending beyond the area of exposure and slight edema, partly extending beyond the area of exposure in addition to dryness of the skin during the observation period. The average score (24 to 72 hours) for irritation was calculated to be 2.7 for erythema and 0.3 for edema. The cutaneous reactions were reversible in the animal within 14 days after removal of the patch. After the exposure period of 4 hours slight to moderate erythema was noted in addition to dryness of the skin during the course of the study. The average score (24 to 72 hours) for irritation was calculated to be 1.7 for erythema and 0.0 for edema. The cutaneous reactions (with the exception of dryness of the skin) were reversible in all animals within 7 days after removal of the patch.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Taking into account the described cutaneous reactions and the average scores for irritation under the test conditions chosen as well as the results of the EpiDermTM Skin Cyclohexanone is considered to be a skin irritant.