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EC number: 604-593-2 | CAS number: 147622-85-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-02-09 to 2001-03-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 07-1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-[4-trans-(3,4-Difluorophenyl)-cyclohexyl]-cyclohexanone
- EC Number:
- 604-593-2
- Cas Number:
- 147622-85-3
- Molecular formula:
- C18 H22 F2 O
- IUPAC Name:
- 4-[4-trans-(3,4-Difluorophenyl)-cyclohexyl]-cyclohexanone
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Crl:KBL
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Kisslegg, Germany
- Age at study initiation: 19 weeks
- Weight at study initiation: 3.02 - 3.56 kg
- Housing: separately in Becker type K99/30 KU cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18
- Humidity (%): 45 - 48
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: Days 1 to 8
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- Before application, the test material was moistened with aqua pro injectione
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 500 mg
VEHICLE
Name: aqua pro injectione - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 8 days
- Number of animals:
- 3 f
- Details on study design:
- TEST SITE
500 mg of the test item was mixed with some drops of Aqua pro injectione to ensure good contact with the skin. Afterwards the test material was spread onto 6 cm2 patches and applied to the intact skin of previously shaven rabbits. The patch was fastened to the left side of the animal's back and kept in place by a self-adhesive fabric (Fixomull® stretch, Beiersdorf). According to the result of a pretest (HET-CAM), which revealed no irritating potential, the animal study was started with three animals.
REMOVAL OF TEST SUBSTANCE
After 4 hours exposure the patches were removed and any test material left was wiped off.
OBSERVATION TIME POINTS
The rabbits were investigated for skin alterations, behaviour, and general condition 1 hour after removal of the patches, after 24, 48 and 72 hrs, and then daily up to study day 8.
Body weight was recorded on days 1, 5 and 8.
SCORING SYSTEM
Skin changes at the application site were evaluated according to the DRAIZE and OECD recommendations.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- According to the results of this study the test material was not regarded as irritant for the skin.
Any other information on results incl. tables
Study design
To test for primary skin irritation, 500 mg of the test item was mixed with some drops of Aqua pro injectione to ensure good contact with the skin. Afterwards the test material was spread onto 6 cm2 patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. According to the result of a pretest, the animal study was started with three animals. The first examination of the treated skin sites followed 1 hour after removal of the patches. Then, examinations were performed daily for a further 7 days.
Results
Under the conditions of the present study no signs of irritation were seen (mean scores of 0 at all time points).
Conclusion
No skin irritating potential could be detected. Therefore the test item has not be classified as a skin irritant.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin irritating potential could be detected.
- Executive summary:
This study was performed according to GLP and methods applied are fully compliant with OECD GL 404. For the test item no skin irritating potential could be detected.
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