2,6-dimethylheptan-2-ol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

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

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

Specific details on test material used for the study:

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

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

None

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

Preliminary study:

Not applicable

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

None

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.

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1969

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Remarks:

Non-GLP study; no data about purity and no certificate of analysis of the test substance; effects on clinical signs, body weights and gross pathology were not reported; observation period: 5 days; no. of animals at highest dose level < 5; no details on the environmental conditions

Reason / purpose for cross-reference:

reference to other study

Principles of method if other than guideline:

Method: Groups of rats (2 or 5/sex/dose) were given a single oral dose of the test item at 4.0, 5.0, 5.5, 6.0 and 7.0 mL/kg bw in corn oil and then observed for mortality for 5 days.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

- Name of test material (as cited in study report): DIMETOL
- Date received: 26 May 1969
- Physical state: Clear colourless liquid

Species:

rat

Strain:

other: CFE rats of Carworth strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 125-150 g
- Housing: Animals were housed in raised wire mesh cages.
- Fasting period before study: 18 h
- Diet: Lab Blox diet, ad libitum
- Water: Ad libitum

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

DOSAGE PREPARATION: Test material was diluted one part to five parts with corn oil (v/v) prior to dosing.

Doses:

4.0, 5.0, 5.5, 6.0 and 7.0 mL/kg bw

No. of animals per sex per dose:

7 mL/kg bw: 2/sex/dose
4.0, 5.0, 5.5 and 6 mL/kg bw: 5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 5 days

Statistics:

LD50 value was calculated using the method of Litchfield and Wilcoxon (1949).

Preliminary study:

Not applicable

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5.82 mL/kg bw

Based on:

test mat.

95% CL:

5.35 - 6.32

Remarks on result:

other: equivalent to 4714 (4333-5119) mg/kg bw; calculated using the density of 0.81 g/L (literature)

Mortality:

- Mortalities were 0/10, 2/10, 3/10, 6/10 and 4/4 at 4.0, 5.0, 5.5, 6.0 and 7.0 mL/kg bw, respectively.

Clinical signs:

other: No data

Gross pathology:

No data

Other findings:

None

None

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of DIMETOL is higher than 2000 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, groups of CFE rats (2 or 5/sex/dose) were given a single oral dose of DIMETOL at 4.0, 5.0, 5.5, 6.0 and 7.0 mL/kg bw in corn oil. Animals were then observed for mortality for 5 days and LD50 value was calculated using Litchfield and Wilcoxon method (1949).

After 5 days, mortalities were 0/10, 2/10, 3/10, 6/10 and 4/4 at 4.0, 5.0, 5.5, 6.0 and 7.0 mL/kg bw, respectively. In this study, the combined oral LD50 of DIMETOL in rats was considered to be 5.82 (5.35-6.32) mL/kg bw [equivalent to 4714 (4333-5119) mg/kg bw; calculated using the density of 0.81 g/L (literature)]

The oral LD50 of DIMETOL is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the CLP Regulation.