Registration Dossier
Registration Dossier
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EC number: 213-995-3 | CAS number: 1071-76-7
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation Of Subchronic Toxicity Of n-Butyl Acetate Vapor.
- Author:
- David, R.M., Tyler, T. R., Ouellette, R., Faber, W.D., Banton, M. I., Garman, R.H., Gill, M.W. and O’Donoghue, J.L.
- Year:
- 2 001
- Bibliographic source:
- Fd. Chem. Toxicol. 39: 877-886, 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.2450 (90-Day Inhalation Toxicity)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- N-butyl acetate
- EC Number:
- 204-658-1
- EC Name:
- N-butyl acetate
- Cas Number:
- 123-86-4
- Molecular formula:
- C6H12O2
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 6 h/d, 5 d/week. For 65 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm
- Dose / conc.:
- 500 ppm
- Dose / conc.:
- 1 500 ppm
- Dose / conc.:
- 3 000 ppm
- No. of animals per sex per dose:
- 15
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- reduced activity levels (less movement, decreased alertness, and slower response)
- Mortality:
- no mortality observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 1 500 ppm
- System:
- central nervous system
- Organ:
- other: central nervous system
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- yes
Applicant's summary and conclusion
- Conclusions:
- n-butyl acetate NOAEL of 500 ppm was reported for systemic effects in rats.
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