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Toxicological information

Acute Toxicity: dermal

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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

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:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals 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.