Registration Dossier
Registration Dossier
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EC number: 203-561-1 | CAS number: 108-21-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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, H.F., Carpenter, C.P., Weil, C.S. and Pozzani, U.C.
- Year:
- 1 954
- Bibliographic source:
- AMA Archives of Industrial Hygiene and Occupational Medicine, 10:61-68.
Materials and methods
- Principles of method if other than guideline:
- Study preceded guidelines. Principles of method similar to those of guideline studies.
- GLP compliance:
- no
- Test type:
- standard acute method
- 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:
- rat
- Strain:
- other: Carworth-Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4-5 weeks of age
- Weight at study initiation: 90 – 120 grams
- Fasting period before study: not fasted before dosing
- Diet (e.g. ad libitum): Rockland rat diet complete
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Chemicals were diluted with water, corn oil, or a 1% solution of sodium 3, 9-diethyl-6-tridecanol sulfate (Tergitol Penetrant 7) when necessary to bring the volume given one rat to between 1 and 10 ml.
- Doses:
- Single dose. The dosages were arranged in a logarithmic series.
- No. of animals per sex per dose:
- 5 male rats per group
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- 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. The reported range shows limits of ± 1.96 standard deviations.
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 6 750 mg/kg bw
- Remarks on result:
- other: The reported range was 6,160 – 7,380 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
In an early study, Smyth et al (1954) reported an acute oral LD50 value of 6750 mg/kg for isopropyl acetate in male rats.
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