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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Maximum 8-hr exposure with 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:
Groups of 6 male or female rats were exposed to an atmosphere containing the test material for up to eight hours. After termination of exposure, the animals were observed for mortality for a period of 14 days.

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:
other: See Principles of Method below
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
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: air
Details on inhalation exposure:
Rats were exposed (whole body) to a flowing stream of vapor-laden air. The vapor-air mixture was generated by passing 2.5 liters/minute of dried air at room temperature through a fritted glass disc immersed to a depth of at least one inch in approximately 50 mL of the test chemical contained in a gas-washing bottle. Inhalation was continued for time periods in a logarithmic series with a ratio of two extending from one-quarter to eight hours, until the inhalation period killing about half the number of rats within 14 days was defined.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
8 h
Remarks on duration:
With this method, inhalation periods are usually four hours unless slight toxicity necessitated a longer exposure.
Concentrations:
Identified only as "vapor-ladened air"
No. of animals per sex per dose:
6 males or females
Control animals:
not specified
Details on study design:
Groups of six male or female albino rats were exposed to a flowing stream of vapor-laden air for up to eight hours. The atmosphere was generated by passing 2.5 L/min of dried air at room temperature through the test material contained in a glass washing bottle. Following exposure, animals were observed for two weeks. Inhalations were continued for time periods in a logarithmic series with a ratio of 2 extended from one-quarter to 8 hours, until the inhalation period killing one half of the animals within 14 days was defined.
Statistics:
No information

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
other: Maximum time for no deaths from exposure to concentrated vapors
Exp. duration:
8 h
Remarks on result:
other: No deaths from exposure to concentrated vapors
Mortality:
None

Any other information on results incl. tables

No concentrations were provided in the study. Degree of lethality was expresssed by the length of exposure time that resulted in no deaths from concentrated inhalation exposure.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
An LC50 could not be determined since no mortality was observed in rats following exposure to vapor-laden air for up to eight hours. Under conditions used in this study, Texanol Ester-Alcohol was not acutely toxic by the inhalation route in rats exposed to concentrated vapors in air for up to eight hours.

Based on an absence of lethality in rats exposed to concentrated vapors in air for up to eight hours, Texanol® Ester-Alcohol is not classified for "Acute Toxicity" by the inhalation route according to GHS.
Executive summary:

In an acute inhalation toxicity study in which groups of six male or female albino rats were exposed to vapor-laden concentrations of air containing Texanol Ester-Alcohol for up to eight hours, no deaths occurred. Based on the results of this study, Texanol Ester-Alcohol is not classified for toxicity by the inhalation route at this exposure concentration.