3,5,5-trimethylcyclohex-2-enone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975 - 1976-06-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

publication

Title:

Contribution a l'etude analytique toxicologique et biochimique de l'isophorone.

Author:

Dutertre-Catella H

Year:

1976

Bibliographic source:

Thesis, Universite Rene Descartes, Paris.

Report date:

1976

Materials and methods

Principles of method if other than guideline:

Method: based on Draize, modified method

GLP compliance:

not specified

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: other TS: Elf Atochem S.A.

Test animals

Species:

rabbit

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ORGANISMS: 
- Weight at study initiation: ca. 2.5 kg
- Controls: yes

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

ADMINISTRATION: 
- Occlusion: yes
- Vehicle: none
- Doses: 9.2; 13.85; 23; 23; 32.3 g   
absorbed: see Results
- Removal of test substance: after 24 hours, unresorbed quantity  determined

Duration of exposure:

24 hours

Doses:

600 mg/kg, 750 mg/kg, 1700 mg/kg, 2500 mg/kg and 2850 mg/kg

No. of animals per sex per dose:

6

Control animals:

yes

Details on study design:

EXAMINATIONS: mortality, clinical signs, skin reaction, 
14 days postexposure observation, autopsy

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 200 mg/kg bw

Mortality:

- Number of deaths and time at each dose: 
9.2 g dose(0.6 +/- 0.4 g/kg absorbed): none
13.85 g dose (0.75 +/- 0.5 g/kg): 2 after 6 and 12 hours, resp.
23 g dose (1.7 +/- 0.9 g/kg): 3 after 3, 4, and 5 hours, resp.
23 g dose (2.85 +/- 1.3 g/kg): 3 after 4, 6, and 48 hours, resp.
32.3 g dose (2.5 +/- 1 g/kg): 6 after 2.5, 4x4, 5 hours, resp.

Clinical signs:

other: CLINICAL SIGNS: accelerated breathing, prostration, narcosis, death (mostly within 6 hours) or recovery. The intensity of the erythema varied   between animals. Recovery of the skin was not always complete within the  postexposure period. Doses at which c

Gross pathology:

no data

Other findings:

- POTENTIAL TARGET ORGANS: none identified (except skin)
- SEX-SPECIFIC DIFFERENCES: none identified

Any other information on results incl. tables

no remarks

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, the acute toxicity of isophorone after dermal application to male and female rabbits is moderate: the LD50 value
was determined to be 1200 mg/kg bw.

Executive summary:

The acute dermal toxicity was evaluated by standard acute method. A single application of test item to the intact skin of six female and six male rabbits was made at dosage levels of 600 mg/kg bw to 2850 mg/kg bw for 24 hours.The animals were observed for mortality and any sub-lethal effects for 14 days after application. Isophorone was dermally of moderate acute toxicity. The LD50 value in rabbits was estimated to be 1200 mg/kg bw. Clinical signs were accelerated breathing, prostration and narcosis.