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EC number: 201-126-0 | CAS number: 78-59-1
Toxicological information
Repeated dose toxicity: oral
Currently viewing:
Administrative data
- Endpoint:
- sub-chronic 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:
- publication
- Title:
- 90-Day subchronic toxicity of isophorone in the rat.
- Author:
- Rohm & Haas Co. / Affiliated Medical Research, Inc., Princeton, N.J.
- Year:
- 1 972
- Bibliographic source:
- Contract No. 120-1008-61, NTIS/OTS 0205975, Doc No. 878212178
- Reference Type:
- review article or handbook
- Title:
- Isophorone: Ambient water quality criteria.
- Author:
- U.S. EPA (Environmental Protection Agency)
- Year:
- 1 978
- Bibliographic source:
- Report No. PB-296 798, U.S. Department of Commerce / National Technical Information Service
- 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:
- no guideline followed
- Principles of method if other than guideline:
- Male and female CFE rats were orally treated with three different doses of the test substance administered via their diet daily for a period of 90 days.
- GLP compliance:
- no
- 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:
- other: CFE
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 750 ppm
- Remarks:
- corresponds to 57 mg/kg bw/d in males and 78.9 mg/kg bw/d in females
- Dose / conc.:
- 1 500 ppm
- Remarks:
- corresponds to 102.5 mg/kg bw/d in males and 163.8 mg/kg bw/d in females
- Dose / conc.:
- 3 000 ppm
- Remarks:
- corresponds to 233.8 mg/kg bw/d in males and 311.8 mg/kg bw/d in females
- No. of animals per sex per dose:
- 20
After 4 weeks, 5 animals per sex and dose group were killed for blood analysis. - Control animals:
- yes, concurrent no treatment
- Details on study design:
- Post-exposure period: none
Examinations
- Observations and examinations performed and frequency:
- Clinical signs: daily
Mortality: daily
Body weight: weekly
Food consumption: weekly
Water consumption: weekly
Ophthalmoscopic examination: no
Hematology: after 4 weeks and at the end of the study: determination of hemoglobin, hematocrit, erythrocyte counts, leukocyte counts, and differential leukocyte determinations
Biochemistry: after 4 weeks and at the end of the study: blood glucose, blood urea nitrogen, serum glutamic oxaloacetic transaminase, serum alkaline phosphatase, total serum protein, total serum bilirubin, serum albumin, lactic acid dehydrogenase, cholesterol, calcium, phosphate, and uric acid
Urinalysis: after 4 weeks and at the end of the study: pH, glucose, ketones, albumin, occult blood, microscopic examination of sediment - Sacrifice and pathology:
- ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC)
Organ weights: Organ-body weight ratios: heart, liver, kidney, adrenals, thyroid, brain, testes
Macroscopic: After 4 weeks and at study termination: lungs, heart, intestines, kidneys, spleen, liver, urinary bladder
Weights: Heart, liver, kidney, adrenals, thyroid, brain, testes (males) for 10 males and 10 females of each dose level
Microscopic: At study termination: 5 males and 5 females each from high dose and control groups: brain, pituitary, eye, thyroid, lung, heart, liver, kidney, adrenals, urinary bladder, mediastinal lymph node, pancreas, spleen, colon, bone marrow, skeletal muscle, testes and prostate (male), ovary and uterus (female). 5 males and 5 females each from medium and low dose groups: liver, kidney. - Statistics:
- All data were evaluated statistically.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- 1 male (control group), 1 female (3000 ppm): deaths were due to intercurrent infection
- Description (incidence and severity):
- - 3000 ppm, males: significantly reduced body weight gain (P < 0.01); further observed changes returned to normal in the subsequent weeks
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- - kidney, testes, males: slightly increased mean organ to body weight ratio (considered not compound-related by the authors; not statistically significant)
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- corresponding to 311.8 mg/kg bw/d
- Effect level:
- 3 000 ppm
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: no adverse effects up to and including the highest tested dose
- Dose descriptor:
- NOAEL
- Remarks:
- corresponding to 102.5 mg/kg bw/d
- Effect level:
- 1 500 ppm
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: reduced body weight gain
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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