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Toxicological information

Acute Toxicity: dermal

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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

Constituent 1
Chemical structure
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.