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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published screening study for acute oral toxicity; limited methodological detail but sufficient for the purposes of classification
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1974
Report date:
1973
Reference Type:
secondary source
Title:
Unnamed
Year:
1974
Report date:
2011

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Screening study for acute oral toxicity, with LD50 calculation
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
n-hexyl acetate
IUPAC Name:
n-hexyl acetate
Constituent 2
Reference substance name:
acetic acid hexyl ester
IUPAC Name:
acetic acid hexyl ester
Constituent 3
Chemical structure
Reference substance name:
Hexyl acetate
EC Number:
205-572-7
EC Name:
Hexyl acetate
Cas Number:
142-92-7
Molecular formula:
C8H16O2
IUPAC Name:
hexyl acetate
Test material form:
not specified
Details on test material:
No details provided

Test animals

Species:
rat
Strain:
other: Carworth-Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
Groups of 5 non-fasted Carworth-Wistar male rats, 4 - 5 weeks old and weighing 90 - 120 grams, were administered a single dose of the undiluted test material by gastric intubation. The animals were observed for mortality during a 14-day observation period, and the LD50 was estimated by the Thompson and Weil method.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Animals were administered a single dose of the undiluted test material by gastric intubation. If lesser concentrations were necessary, the test material was diluted as a solution in water or corn oil, or as a suspension in semi-solid agar.
Doses:
No details provided.
No. of animals per sex per dose:
Groups of five male rats
Control animals:
not specified
Details on study design:
No details
Statistics:
LD50 estimated using Thompson and Weil method

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
41.5 mL/kg bw
Based on:
test mat.
95% CL:
> 30.7 - < 56.1
Remarks on result:
other: Assuming a specific gravity value of approximately 1 g/mL, the LD50 value is ~41.5 g/kg bw.
Mortality:
No information on rat mortality
Clinical signs:
No information provided for clinical signs
Body weight:
No information provided in publication
Gross pathology:
No information provided in publication
Other findings:
Not reported

Any other information on results incl. tables

The acute oral LD50 was found to be 41.5 g/kg bw.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Assuming density of 1 g/mL; the acute oral LD50 value of 41.5 mL/kg bw is equivalent to 41500 mg/kg bw or 41.5 g/kg bw.
Executive summary:

Groups of 5 non-fasted Carworth-Wistar male rats, 4 - 5 weeks old and weighing 90 - 120 grams, were administered a single dose of the undiluted test material by gastric intubation. The animals were observed for mortality during a 14-day observation period, and the LD50 was estimated by the Thompson and Weil method. The acute oral median lethal dose is quoted as 41.5 ml/kg bw for rats (confidence limits 30.7 to 56.1 ml/kg bw), equivalent to approximately 41.5 g/kg bw.