3-methyl-1,3-butandiol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5 March 1987 - 27 March 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD and EPA guidelines and EEC regulations

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-methyl-1,3-butandiol

EC Number:

459-270-7

EC Name:

3-methyl-1,3-butandiol

Cas Number:

2568-33-4

Molecular formula:

C5 H12 O2

IUPAC Name:

3-methylbutane-1,3-diol

Test material form:

liquid

Specific details on test material used for the study:

The test material, a clear colourl ess liquid. was stored in the dark under ambient conditions.

Test animals

Species:

mouse

Strain:

CD-1

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approximately 6-8 weeks old
- Weight at study initiation: 20-30 g
- Fasting period before study: 4-6 hours
- Housing: suspended polypropylene cages wi th stainl ess steel grid tops and with woodshavings for bedding
- Diet (e.g. ad libitum): not specified
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 45%
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Distilled water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

Dose ranging: 100, 500, 1000, 3000 and 5000 mg/kg
Main study: 2000 and 5000 mg/kg

No. of animals per sex per dose:

2

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: immediately prior to dosing, 7 days after dosing and at the end of the 14 day observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:

No clinical signs were noted at any time after dose administration .
No deaths occurred and no abnormal ities were noted at.gross post mortem examination.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

other: No clinical signs were noted at any time after dose administration.

Gross pathology:

No abnormalities were noted at gross post mortem examination .

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Following acute oral adminstration of the test item to male and female CD-1 mice, no deaths occurred.
It is concluded that the Median Oral lethal Dose (LD50) is greater than 5000 mg/kg.