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Toxicological information

Repeated dose toxicity: inhalation

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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:
2001
Bibliographic source:
Fd. Chem. Toxicol. 39: 877-886, 2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OTS 798.2450 (90-Day Inhalation Toxicity)
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

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.