Registration Dossier
Registration Dossier
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EC number: 411-490-4 | CAS number: 7027-11-4 ISOPHORONENITRILE, IPN
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991-01-22 to 1991-02-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- 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/78/90. Purity 99.6 % (GC).
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: White Russian
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Source: Asta Pharma AG, Bielefeld (Germany)
- Age: males 13-20 months, females 9-13 months
- Weight at study initiation: 5 males 2.17-2.93 kg, 5 females 2.68-3.06 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): 22 - 23 °C
- Humidity (%): 40 - 60 % (for short periods down to 18 %)
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours dark
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- ADMINISTRATION:
- Area covered: dorsal skin between shoulder and sacrum (clipped free of hair 1 day in advance)
- Preparation of test substance: moistening with vehicle (water)
- Concentration in vehicle: 50 % w/w
- Occlusion: linen cloth, synthetic film glue, aluminum leaf, Acrylastic bandage
- Removal of test substance: patch removal and gentle washing after 24 hours
- Post dose observation period: 14 days - Duration of exposure:
- patch removal and gentle washing after 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- EXAMINATIONS:
- Body weights: days 0, 7, and 14
- Clinical signs: within 4-6 hours after dosing, thereafter once daily
- Mortality: Twice daily on regular working days, once daily on weekends and national or business holidays
- Necropsy: Including external appearance, body orifices, body cavities (thoracic and abdominal), and their contents (all animals) - Statistics:
- no statistics because limit test
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- MORTALITY: No deaths occurred
- Clinical signs:
- CLINICAL SIGNS: No signs of toxicity were observed
- Body weight:
- BODY WEIGHT: Body weights were approximately constant
- Gross pathology:
- NECROPSY FINDINGS: No alterations were detected
- Other findings:
- no other findings
Any other information on results incl. tables
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU Directive 67/548/EEC
- Conclusions:
- The dermal LD50 values for male and female rabbits were above 2000 mg/kg b.w.
- Executive summary:
Isophorone nitrile was tested for acute toxicity after single dermal application to rabbits at a dose of 2000 mg/kg b.w..
The solid test substance was moistened with water and placed on the shorn dorsal skin of 5 male and 5 female animals under occlusive conditions for 24 hours. The dermal exposure produced neither signs of toxicity nor deaths. Therefore the dermal LD50 values for male and female rabbits were above 2000 mg/kg b.w.
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