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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:
weight of evidence
Study period:
6-hour exposure followed by 14-day observation period
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted prior to Good Laboratory Practices; data from a summary report; limited number of animals; actual test report not available for review. Study was conducted by an internal Eastman Kodak Company method, developed prior to established guidelines.

Data source

Reference
Reference Type:
other: Eastman Kodak Company Summary Report
Title:
Unnamed
Year:
1961
Report Date:
1961

Materials and methods

Test guideline
Qualifier:
no guideline available
Deviations:
not specified
Principles of method if other than guideline:
Method is an in vivo study using a group of three rats (sex, strain, and weights not available) exposed to an atmosphere containing the test material for a period of six hours. After termination of exposure, the animals were observed for mortality and adverse clinical signs for a period of 14 days. Body weights were measured prior to exposure and at termination of the 2-week observation period.
GLP compliance:
no
Test type:
other: Study conducted according to an internal Eastman Kodak Company laboratory method, using a 6-hour inhalation exposure period to rats.
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
no data

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
other: air
Details on inhalation exposure:
Rats were exposed (whole-body) to an ambient (room) atmosphere containing 0.12 mg/L (10 ppm) of the test material for a period of six hours. The atmosphere was generated by passing room air at a rate of 3.5 L/minute through a washing bottle containing TXIB. The atmosphere generated in this manner was then passed into the chamber containing the rats.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
6 h
Concentrations:
0.12 mg/L
No. of animals per sex per dose:
3 (sex not specified)
Control animals:
no
Details on study design:
Three rats (sex, strain, and weights not available) were exposed (whole-body) to an ambient (room) atmosphere containing 0.12 mg/L (10 ppm) of the test material for a period of six hours. The atmosphere was generated by passing room air at a rate of 3.5 L/minute through a washing bottle containing TXIB. The atmosphere generated in this manner was then passed into the chamber containing the rats. Animals were observed for mortality and adverse effects for a period of 14 days. Body weights were recorded prior to exposure to the test material and at termination of the observation period.

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LCLo
Effect level:
> 0.12 mg/L air
Exp. duration:
6 h
Mortality:
None
Clinical signs:
other: No signs of systemic toxicity or abnormal clinical signs were noted during the study.
Body weight:
All animals gained weight (average 13 grams) over the 14-day observation period.
Gross pathology:
not performed

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Under conditions used in this study, 2,2,4-trimethylpentanediol-1,3-diisobutyrate (TXIB; Texanol Isobutyrate) was not acutely toxic by the inhalation route in rats when exposed to a concentration of 0.12 mg/L of air for 6 hours. Since no mortality was noted at this exposure level, the LCLo in rats was greater than 0.12 mg/L of air/6 h.

Based on an acute inhalation LCLo value of > 0.12 mg/L of air/6 h, Eastman TXIB is not classified for "Acute Toxicity" by the inhalation route according to GHS. Based on an absence of significant clinical signs or other systemic effects, the test material is also not classified for "Specific Target Organ Toxicity - Single Exposure" according to GHS.
Executive summary:

In an acute inhalation toxicity study, 3 rats were exposed to 2,2,4-trimethylpentanediol-1,3-diisobutyrate (TXIB; Texanol Isobutyrate) at a concentration of 0.12 mg/L of air for a period of 6 hours. Under the conditions of this study, no deaths occurred and the LCLo was considered to be greater than 0.12 mg/L. No abnormal clinical signs or signs of systemic toxicity were evident during a 14-day observation period. All animals gained weight over the course of the study. Based on the results of this study, 2,2,4-trimethylpentanediol-1,3-diisobutyrate (TXIB; Texanol Isobutyrate) is not classified for toxicity by the inhalation route at this exposure concentration.