Registration Dossier
Registration Dossier
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EC number: 411-490-4 | CAS number: 7027-11-4 ISOPHORONENITRILE, IPN
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-06-19 to 1990-06-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-cyano-3,5,5-trimethylcyclohexanone
- EC Number:
- 411-490-4
- EC Name:
- 3-cyano-3,5,5-trimethylcyclohexanone
- Cas Number:
- 7027-11-4
- Molecular formula:
- C10H15NO
- IUPAC Name:
- 3-cyano-3,5,5-trimethylcyclohexanone
- Details on test material:
- Isophorone nitrile of Degussa AG. Batch No. 64 II / 192 V / 89. Purity 99.8 % (GC).
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: White Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Strain: White Russian
- Source: ASTA Pharma AG, Bielefeld (Germany)
- Sex: 1 male, 2 females
- Age: 11 months
- Weight at study initiation: male 2.52 kg, females 2.85 and 2.87 kg
- Housing: single housing
- Diet: ad libitum, special diet for rabbits, SSniff K
- Water: ad libitum, tab water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 24 °C
- Humidity (%): 45 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours dark
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: opposite side of dorsal skin
- Amount / concentration applied:
- Concentration: 50 %
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- - Postexposure period: 3 days
- Number of animals:
- 3
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Preparation of test substance: moistening with vehicle (water)
- Area of exposure: shorn dorsal skin between sholder and sacrum
- Total volume applied: 0.5 g test substance + 0.5 ml water
- Occlusion: linen cloth, synthetic film glue, Acrylastic bandage
- Removal of test substance: gentle washing
EXAMINATIONS
- Examination time points: 1, 24, 48, and 72 hours after patch removal
- Scoring system: Draize (1944 / 1959 / 1965); evaluation: Gilman et al. (1983)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 0.0
- Edema: 0.0 - Other effects:
- OTHER EFFECTS: Systemic-toxic effects did not occur. The general condition of the test animals was not affected.
Any other information on results incl. tables
REVERSIBILITY: not applicable
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Draize Scores and according to EU Directive 67/548/EEC
- Conclusions:
- Isophorone nitrile is classified as non-irritant on the skin of the rabbit.
- Executive summary:
Isophorone nitrile was investigated for primary cutanaous irritant/corrosive effects at the skin of 1 male and 2 female rabbits. The test substance was given to the dorsal skin area of three rabbits for 4 hours occlusive. During the observation period neither erythema nor edema could be detected, as well as no systemic toxic effects.
With an irritation index of 0.0 isophorone nitrile is classified as non-irritant on the skin of the rabbit.
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