Registration Dossier
Registration Dossier
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EC number: 203-561-1 | CAS number: 108-21-4
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1954
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. Meets basic scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- Range-finding Toxicity Data, List V.
- Author:
- Smyth .F, Carpenter CP, Weil CS, Pozzani UC.
- Year:
- 1 954
- Bibliographic source:
- AMA Archives of Industrial Hygiene and Occupational Medicine, 10:61-68.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Study pre-dates guideline methods. Study performed according to the 24 hour cuff method (Draize et al, 1944).
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Isopropyl acetate
- EC Number:
- 203-561-1
- EC Name:
- Isopropyl acetate
- Cas Number:
- 108-21-4
- Molecular formula:
- C5H10O2
- IUPAC Name:
- isopropyl acetate
- Details on test material:
- - Name of test material (as cited in study report): Acetic acid, isopropyl ester
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.5 to 3.5 kg
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The fur is closely clipped over the entire trunk
- % coverage: 1/10 of the body surface.
- Type of wrap if used: impervious plastic film. - Duration of exposure:
- 24 hours
- Doses:
- 20 ml/kg
- No. of animals per sex per dose:
- 4
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: The animals were immobilized during the 24-hour period after which the film was removed and the animals caged for the remainder of the 14-day observation period.
- Statistics:
- Based upon the mortalities observed during a 14-day observation period, the most probable LD50 value and its fiducial range was estimated by the method of Thompson using the Tables of Weil.
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 20 mL/kg bw
Any other information on results incl. tables
No range was reported since the LD50 was greater than the highest dose tested. Based on a density of 0.8718, the applied dose was 17.4 g/kg.
Applicant's summary and conclusion
- Executive summary:
Smyth et al (1954) reported an acute dermal LD50 value of > 20 ml/kg (17.4 g/kg) for isopropyl acetate in rabbits.
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