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EC number: 212-855-9 | CAS number: 873-94-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-10-09 to 1995-10-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 3,3,5-trimethylcyclohexan-1-one
- EC Number:
- 212-855-9
- EC Name:
- 3,3,5-trimethylcyclohexan-1-one
- Cas Number:
- 873-94-9
- Molecular formula:
- C9H16O
- IUPAC Name:
- 3,3,5-trimethylcyclohexan-1-one
- Details on test material:
- 3,3,5-trimethylcyclohexanone of Hüls AG, purity 98.7 % (GC-FID area), produced April 1995, ID No. 0637/81 736, internal No. 0166
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Strain: Cpb/Win:WU (SPF)
- Source: Harlan Winkelmann GmbH, Borchen (Germany)
- Weight at study initiation: males 142-169 g, females 110-119 g
- Controls: no
- Fasting period before study: 16 hours
- Diet: ad libitum, R10 special diet for rats, SSniff R
- Water: ad libitum, tab water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours dark
- Air changes (per hr): 15 per hour
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- ADMINISTRATION:
- undiluted
- Doses per time period: single dose (gavage)
- Volume administered or concentration: 2.25 ml/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- EXAMINATIONS:
- Mortality, clinical signs: 30 minutes, 1, 2, 3, 4, 5, 6 hours after dosing, once daily for next 2 weeks
- Body weights: days 0, 7, and 14
- Post dose observation period: 14 days
- Macroscopic examination: directly after exitus (animal that died) / day 14 (surviving animals)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- MORTALITY: 1 male animal died after 5 hours, no other deaths occurred.
- Clinical signs:
- other: CLINICAL SIGNS: Three male and five female animals showed more or less severe signs of toxicity within the first hours after treament but were (except animal that died) free from symptoms 24 hours after treatment. Signs were most pronounced in two mal
- Gross pathology:
- NECROPSY FINDINGS: No indications of treatment related macroscopic organ changes were observed in the surviving animals, except for a focal
thickening of the cutaneous gastric mucosa in one female. The animal that died had a dark red, almost black liver, punctiform bleeding in the
glandular gastric mucosa, which was not folded alongside, and a hypostatic change in the right pulmonary lobe. - Other findings:
- no other findings
Any other information on results incl. tables
no further remarks
Applicant's summary and conclusion
- Conclusions:
- According to this study the LD50 value (oral) was determined to > 2000 mg/kg bw in rats for the test item 3,3,5-trimethylcyclohexanone
- Executive summary:
In an acute oral toxicity study according OECD 401 a single dose of 2000 mg/kg 3,3,5-trimethylcyclohexanone was applied to 5 Wistar rats/sex. The observation period was 14 days.
One male rat died 5 hours after application. Within the first hours after treatment the animals showed sedation, abdominal position, gasping breathing, and hypothermia, 24 hours after treatment they were free from symptoms. No indications of treatment related macroscopic organ changes were observed in the surviving animals, except for a focal thickening of the cutaneous gastric mucosa in one female.
Under conditions of this study the LD50 value (oral) is above 2000 mg/kg bw in Wistar rats.
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