1-isopropyl-2,2-dimethyltrimethylene diisobutyrate

Acute Toxicity: inhalation

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

Test material information

Constituent 1

Reference substance name:

Propanoic acid, 2-methyl-, 1,1'-[2,2-dimethyl-1-(1-methylethyl)-1,3-propanediyl] ester

IUPAC Name:

Propanoic acid, 2-methyl-, 1,1'-[2,2-dimethyl-1-(1-methylethyl)-1,3-propanediyl] ester

Constituent 2

Reference substance name:

1-isopropyl-2,2-dimethyltrimethylene diisobutyrate

EC Number:

229-934-9

EC Name:

1-isopropyl-2,2-dimethyltrimethylene diisobutyrate

Cas Number:

6846-50-0

Molecular formula:

C16H30O4

IUPAC Name:

trimethoxy[3-(oxiran-2-ylmethoxy)propyl]silane

Constituent 3

Reference substance name:

2,2,4-Trimethylpentanediol-1,3-diisobutyrate

IUPAC Name:

2,2,4-Trimethylpentanediol-1,3-diisobutyrate

Constituent 4

Reference substance name:

Texanol isobutyrate; TXIB

IUPAC Name:

Texanol isobutyrate; TXIB

Details on test material:

no data

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system 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.