Isobutyric acid, monoester with 2,2,4-trimethylpentane-1,3-diol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Single 24-hour application 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 dermal toxicity of Texanol Ester-Alcohol was estimated by application of varying doses of the undiluted test material to the clipped abdomens of four male New Zealand White rabbits. The test material was held in place under an impervious plastic film for 24 hours. 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

Test material information

Constituent 1

Reference substance name:

Propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol

IUPAC Name:

Propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol

Constituent 2

Reference substance name:

Isobutyric acid, monoester with 2,2,4-trimethylpentane-1,3-diol

EC Number:

246-771-9

EC Name:

Isobutyric acid, monoester with 2,2,4-trimethylpentane-1,3-diol

Cas Number:

25265-77-4

Molecular formula:

C12H24O3

IUPAC Name:

3-hydroxy-2,2,4-trimethylpentyl 2-methylpropanoate

Constituent 3

Reference substance name:

(3-hydroxy-2,2,4-trimethylpentyl) 2-methylpropanoate

IUPAC Name:

(3-hydroxy-2,2,4-trimethylpentyl) 2-methylpropanoate

Constituent 4

Reference substance name:

Texanol Ester-Alcohol; TEXANOL; 2,2,4-trimethyl-1,3-pentanediol monoisobutyrate

IUPAC Name:

Texanol Ester-Alcohol; TEXANOL; 2,2,4-trimethyl-1,3-pentanediol monoisobutyrate

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:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

-Weight at study initiation: 2.5 to 3.5 kg

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The abdomen of each animal was clipped of hair prior to dose administration. A single dose of the undiluted test material was applied to the clipped abdomen and held in place beneath an impervious plastic film. The animals were immobilized during the 24-hour contact period. Then the films were removed and the rabbits caged for a 14-day observation period.

Duration of exposure:

24 hours

Doses:

Not specified

No. of animals per sex per dose:

4 males

Control animals:

not specified

Details on study design:

Groups of four male New Zealand White rabbits, weight 2.5 to 3.5 kg, were administered a single dose of undiluted test material to the clipped abdomen under occlusive contact for 24 hours. Following removal of the impervious covering, animals were 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.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 16 mL/kg bw

Any other information on results incl. tables

The single-dose dermal LD50 for rabbits was expressed as > 16 mL/kg bw. Based on a specific gravity of 0.95 for the test material, the dermal LD50 was > 15200 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 dermal route in male rabbits. The single dose dermal LD50 in male rabbits was > 16 mL/kg bw (> 15200 mg/kg bw).

Based on an acute dermal LD50 value of > 16 mL/kg bw (> 15200 mg/kg bw) in male rabbits, Texanol Ester-Alcohol is not classified for "Acute Toxicity" by the dermal route according to GHS.

Executive summary:

In an acute dermal toxicity study, groups of four male rabbits were administered single doses of Texanol Ester-Alcohol by dermal application under occluded contact for 24 hours. Following removal of the impervious wrapping, animals were observed for 14 days. Under the conditions of this study, the dermal LD50 of Texanol Ester-Alcohol in male rabbits is considered to be > 16 mL/kg bw (> 15200 mg/kg bw). Based on the results of this study, Texanol Ester-Alcohol presents a low acute toxicity hazard by the dermal route.