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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Single dose followed by 14-day observation period
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted prior to the introduction of Good Laboratory Practices and country-specific testing guidelines. Standardized experimental methods were used to test over 300 compounds. Published results presented as a collection of data; methodology also published.

Data source

Reference
Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VIII
Author:
Carpenter CP, Weil CS and Smyth, Jr HF
Year:
1974
Bibliographic source:
Toxicology and Applied Pharmacology 28, 313-319 (1974)

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The acute oral toxicity of Texanol Ester-Alcohol was estimated by administration of the undiluted test material by oral gavage to groups of five non-fasted male rats. The doses were arranged in a logarithmic series differing by a factor of two. Following dose administration, animals were monitored for two weeks. Only the LD50 was reported.

Test method was published in:
Smyth et al., 1962. Range-finding toxicity data: List VI. American Industrial Hygiene Association Journal 23: 95-107.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
-Name of test material (as cited in study report): Isobutyric acid, 2,2,4-trimethyl-1,3-pentanediol monoester, mixed isomers

Test animals

Species:
rat
Strain:
other: Carworth-Wistar
Sex:
male
Details on test animals and environmental conditions:
-Source: internal colony at test facility (Mellon Institute of Industiral Research, Pittsburgh, PA)
-Age at study initiation: 4 to 5 weeks
-Weight at study initiation: 90 to 120 grams
-Diet: Rockland complete rat diet

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Each animal received a single dose of the undiluted test material by oral gavage.
Doses:
Not specifically stated; doses arranged in a logarithmic series differing by a factor of two.
No. of animals per sex per dose:
5 males
Control animals:
not specified
Details on study design:
Groups of five non-fasted male Carworth-Wistar rats, ages 4 to 5 weeks, were administered a single dose of undiluted test material by oral gavage and observed for a 14-day period for mortality.
Statistics:
The most probable LD50 value and its fiducial range were estimated by the method of Thompson using the Tables of Weil. The figures in parentheses show limits of ±1.96 standard deviations.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
6.86 mL/kg bw

Any other information on results incl. tables

The single-dose oral LD50 for rats was expressed as 6.86 (4.64-10.1) mL/kg bw. The figures in parentheses show limits of ± 1.96 standard deviations. Based on a specific gravity of 0.95 for the test material, the LD50 was equivalent to approximately 6500 mg/kg bw.  

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under conditions used in this study, Texanol Ester-Alcohol was not acutely toxic by the oral route in male rats. The single dose oral LD50 in male rats was 6.86 mL/kg bw (approximately 6500 mg/kg bw).

Based on an acute oral LD50 value of 6.86 mL/kg bw (appproximately 6500 mg/kg bw) in male rats, Texanol® Ester-Alcohol is not classified for "Acute Toxicity" by the oral route according to GHS.
Executive summary:

In an acute oral toxicity study, groups of five male rats were administered single doses of Texanol Ester-Alcohol by oral gavage and observed for 14 days. Under the conditions of this study, the oral LD50 of Texanol Ester-Alcohol in male rats is considered to be 6.86 mL/kg bw (approximately 6500 mg/kg bw). Based on the results of this study, Texanol Ester-Alcohol presents a low acute toxicity hazard by the oral route.