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Diss Factsheets

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:
1995
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

Constituent 1
Chemical structure
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

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:
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 males (one of which died) from two  
hours after treatment on: Sedation, abdominal position, gasping  breathing, and hypothermia. 
Body weight:
Body weight development of the surviving animals was normal.
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.