Registration Dossier
Registration Dossier
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EC number: 203-631-1 | CAS number: 108-94-1
Skin irritation / corrosion
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
Test material
- Reference substance name:
- Cyclohexanone
- EC Number:
- 203-631-1
- EC Name:
- Cyclohexanone
- Cas Number:
- 108-94-1
- Molecular formula:
- C6H10O
- IUPAC Name:
- cyclohexanone
- Details on test material:
- purity: 99.93%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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:
- clipped
- 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
- 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.
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