2,6-dimethyloctan-2-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

limit test with 10 males

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

2,6-dimethyloctan-2-ol

EC Number:

242-361-9

EC Name:

2,6-dimethyloctan-2-ol

Cas Number:

18479-57-7

Molecular formula:

C10H22O

IUPAC Name:

2,6-dimethyloctan-2-ol

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Remarks:

albino

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals (received on August 3, 1982)
- Weight at study initiation: 224-297 g
- Fasting period before study: 16-20 hours prior to dosing
- Housing: 5 animals per cage in suspended wire mesh cages.
- Diet (e.g. ad libitum): fresh Purina rat chow (Diet #5012) ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): controlled
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.81 mL

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals observed 3-4 hours post dosing and once daily after for 14 days for mortality, toxicity and pharmocological effects.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died.

Clinical signs:

other: All animals suffered from flaccid muscle tone and lethargy, other signs observed in the animals were ataxia (9 animals), chromorhinorrhea (4), chromodacryorrhea (1), ptosis (1), brown staining of the anogenital area (3).

Gross pathology:

No abnormalities were found.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

based on CLP criteria (1272/2008/EC and its updates)

Conclusions:

Under the conditions of this test, an acute oral LD50 of >5000 mg/kg bw was determined for Tetrahydromyrcenol.

Executive summary:

An acute oral toxicity study was performed according to a method similar to OECD TG 401. In this study, 10 rats were administered Tetrahydromyrcenol at dose levels 5000 mg/kg bw. The mortality rate of the rats was 0/10. Clinical signs observed were flaccid muscle tone and lethargy, ataxia, chromorhinorrhea, chromodacryorrhea, ptosis and brown staining of the anogenital area. Gross necropsy was performed at end of term, but no abnormalities were found. Under the conditions of this test, an acute oral LD50 of >5000 mg/kg bw was determined for Tetrahydromyrcenol.