3,5,5-trimethylcyclohex-2-enone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference 1

Reference Type:

other company data

Title:

Unnamed

Year:

1968

Report date:

1968

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Principles of method if other than guideline:

Method: Acute oral toxicity study in rats - single administration

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

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

Details on test material:

Test substance: isophorone

Test animals

Species:

rat

Strain:

other: Breeder Voss

Sex:

male/female

Details on test animals or test system and environmental conditions:

Study performed with animals of relatively low body weight:  Weight at study initiation: 80-115 g.

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

other: Emulsion 0.5 g carboxymethyl cellulose in 100 ml dist. water

Doses:

Doses: 0.5; 1.0; 1.25; 1.50; 1.75; 2.0; 2.5 g/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Post dose observation period: 13 days;
EXAMINATIONS:  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:

STATISTICAL METHODS: Probit analysis

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 500 mg/kg bw

Remarks on result:

other: LD50 confidence limits: 1400-1800 mg/kg

Mortality:

MORTALITY: 
- Time of 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;
LD50 confidence limits: 1400-1800 mg/kg

Clinical signs:

other: > 1,000 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 hermorrhagic erosions of 
proventiculus lining, - urine retention, - hyperemia of liver, - pulmonary emphysema, edema or hyperemia and - splenic enlargement

Other findings:

no data

Any other information on results incl. tables

no remarks

Applicant's summary and conclusion

Conclusions:

The LD50 value of isophorone in female and male rats was estimated to be 1500 mg/kg bw. Clinical signs like general apathy, lateral position and
irregular respiration occured at doses > 1000 mg/kg bw. The test animals died 1 hour to 3 days after feeding.

Executive summary:

The acute oral toxicity to rats was evaluated by standard acute method. The test item was administered to five female and five male rats orally. The animals were observed for mortality and any sub-lethal effects for 13 days after dosing. Isophorone was orally of moderate acute toxicity: The LD₅₀ value in rats was estimated to be 1500 mg/kg bw. Clinical signs like general apathy, lateral position and irregular respiration occured at doses > 1000 mg/kg bw. Increased secretion in stomach and small intensine, thickening and hermorrhagic erosions of proventiculus lining, urine retention, hyperemia of liver, pulmonary emphysema, edema or hyperemia and splenic enlargement were found at necrospy.