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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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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 clinical signs appeared are not  
defined.
Body weight:
no data
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

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