Registration Dossier
Registration Dossier
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EC number: 202-874-0 | CAS number: 100-64-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23. Jan 1979 to 26. Jan 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Similar to guideline OECD 404 with acceptable restrictions, limited documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EPA guideline (not further specified)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Observation period only up to 48 h after end of exposure
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Cyclohexanone oxime
- EC Number:
- 202-874-0
- EC Name:
- Cyclohexanone oxime
- Cas Number:
- 100-64-1
- Molecular formula:
- C6H11NO
- IUPAC Name:
- cyclohexanone oxime
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): cyclohexanone oxime
- Substance type: white crystalline powder
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bunnyville Farm, Littlestown, USA
- Housing: individually
- Diet (ad libitum): Purina rabbit chow
- Water (ad libitum): automated water supply
Test system
- Type of coverage:
- other: covering by polyethylene tubing and elastic bandage
- Preparation of test site:
- other: 4 shaved application sites per animal, two of it abraded
- Vehicle:
- other: application sites were premoistened with physiological saline before application of the test substance
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per application site - Duration of treatment / exposure:
- 24 h
- Observation period:
- up to 72 h after application (48 h after end of exposure)
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: one square inch
- % coverage: 100
- Type of wrap if used: gauze patch held in place with transparent tape, fixed by a nonabsorbent binder composed of polyethylene tubing and elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): substance was wiped off (no further details)
SCORING SYSTEM: according to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h after application (0 or 48 h after end of exposure)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h after application (0 or 48 h after end of exposure)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Irritant / corrosive response data:
- No irritating effects were observed neither for intact nor abraded skin
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test substance was not irritating
- Executive summary:
Six New Zealand white rabbits were exposed dermally to the test substance according to EPA guidelines (similar to guideline OECD 404). 0.5 g of test item were applied to four shaved application sites per animal, two of which were abraded. After 24 h of exposure the substance was wiped off and the effects evaluated at 24 and 72 h after application. No erythema or edema were observed at any time point, neither on intact nor on abraded skin. Under the conditions of this study, the test substance was not irritating to the skin of rabbits.
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