Registration Dossier
Registration Dossier
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EC number: 201-126-0 | CAS number: 78-59-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 968
- Reference Type:
- other: OECD SIDS
- Title:
- 3,5,5-Trimethylcyclohex-2-enone (Isophorone), CAS No. 78-59-1
- Author:
- OECD SIDS
- Year:
- 2 003
- Bibliographic source:
- SIDS Initial Assessment Report for SIAM 16
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 3,5,5-trimethylcyclohex-2-enone
- EC Number:
- 201-126-0
- EC Name:
- 3,5,5-trimethylcyclohex-2-enone
- Cas Number:
- 78-59-1
- Molecular formula:
- C9H14O
- IUPAC Name:
- 3,5,5-trimethylcyclohex-2-enone
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Voss
- Weight at study initiation: 80 - 115 g
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.5 % CMC - Doses:
- 500; 1000; 1250; 1500; 1750; 2000; 2500 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 13 days
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, other: gross examination of: coat of fur, skin, eye and conjunctiva, nose, mouth, ear, anus, preputial opening, vulva, subcutaneous connective tissue, abdominal cavity, pelvic cavity, peritoneum, esophagus, stomach, small intestine, large intestine, mesenteric lymph nodes, liver, pancreas, spleen, kidneys, urinary bladder, seminal vesicle, prostate, testicles, epididymis, ovary, uterus, vagina, thoracic cavity, pleura, heart, lungs, trachea, thymus gland, cerebrum, middle ear, application sites - Statistics:
- Probit analysis
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 500 mg/kg bw
- 95% CL:
- 1 400 - 1 800
- Mortality:
- Time to death: 1 hour to 3 days after dosing
Number of deaths at each dose:
500 mg/kg: 0/10
1000 mg/kg: 1/10
1250 mg/kg: 1/10
1500 mg/kg: 5/10
1750 mg/kg: 7/10
2000 mg/kg: 10/10
2500 mg/kg: 8/10 - Clinical signs:
- other: > 1000 mg/kg: general apathy, lateral position, irregular respiration
- Gross pathology:
- Necropsy findings (results of animals that died): increased secretion in stomach and small intestine; thickening and hemorrhagic erosions of proventriculus lining; urine retention; hyperemia of liver; pulmonary emphysema, edema, or hyperemia; splenic enlargement
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
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