2,6-dimethylheptan-2-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1976

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Documentation insufficient for assessment: Non-GLP study; no data about purity and no certificate of analysis of the test substance; no details on age, gender, weight and strain of rats and housing conditions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Principles of method if other than guideline:

Standard acute method (limit test)

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,6-dimethylheptan-2-ol

EC Number:

236-244-1

EC Name:

2,6-dimethylheptan-2-ol

Cas Number:

13254-34-7

Molecular formula:

C9H20O

IUPAC Name:

2,6-dimethylheptan-2-ol

impurity 1

Reference substance name:

Unknown impurities

Molecular formula:

not applicable

IUPAC Name:

Unknown impurities

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): Dimetol

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

None

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

None

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

Total no. of animals = 10

Control animals:

no

Details on study design:

- Animals were observed for mortality and clinical signs of toxicity for 14 days.
- Necropsy performed: Yes

Statistics:

None

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

- 2/10 animals died on Day 1.

Clinical signs:

other: - At 2 h, lethargy, ataxia and loss of righting reflex were noted in animals. - At 24 h, lethargy in 3/8 animals and piloerection in 2/8 animals were noted.

Gross pathology:

At necropsy, lungs and stomach were red in 2 animals.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 for Dimetol is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the CLP Regulation.

Executive summary:

In an acute oral toxicity study, 10 rats were given a single oral dose of Dimetol at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs of toxicity for 14 days.

Two of the 10 rats died on Day 1. At 2 h, lethargy, ataxia and loss of righting reflex were noted in rats. At 24 h, lethargy in 3/8 rats and piloerection in 2/8 rats were noted. At necropsy, lungs and stomach were red in 2 rats.

The oral LD50 for Dimetol is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the CLP Regulation.