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Toxicological information

Acute Toxicity: oral

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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

Referenceopen allclose all

Reference Type:
other company data
Title:
Unnamed
Year:
1968
Report Date:
1968
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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance: isophorone

Test animals

Species:
rat
Strain:
other: Breeder Voss
Sex:
male/female
Details on test animals 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:
> 1,000 mg/kg: general apathy, lateral position, irregular respiration
Body weight:
no data
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

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: other: EC Directive 67/548/EEC
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.