3-methoxybutan-1-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, available as unpublished report. No restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-methoxybutan-1-ol

EC Number:

219-741-8

EC Name:

3-methoxybutan-1-ol

Cas Number:

2517-43-3

Molecular formula:

C5H12O2

IUPAC Name:

3-methoxybutan-1-ol

Constituent 2

Reference substance name:

methoxybutanol

IUPAC Name:

methoxybutanol

Details on test material:

- Name of test material (as cited in study report): methoxybutanol
- Physical state: clear, colourless liquid
- Analytical purity: 99.5%
- Lot/batch No.: Hoe CG 0388 0A ZD00 0001
- Expiration date of the lot/batch: August 1996
- pH in water: 7
- Storage condition of test material: in the dark at room temperature
- Stability under test conditions: 4 hours in vehicle

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF Zucht
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 193±8 g (males); 182±3 g (females)
- Fasting period before study: 16 hrs
- Housing: 5 per cage
- Diet: Rattendiat Altromin 1324 ad libitum
- Water: Tap water in bottles ad libitum
- Acclimation period: not required. (Identical to the pre-study conditions)

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C
- Humidity: 55±20%
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 16 October to 5 November 1991

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% (w/v)
- Amount of vehicle (if gavage): 10 mL/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Frequently observed on the day of dosing and then at least daily; weighed on days 0, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

One female died on the day after dosing.

Clinical signs:

other: other: Clinical signs seen in most animals included irregular respiration, stupor, coat bristling, flanks drawn in, stilted or uncoordinated gait, ataxia and decreased activity.

Gross pathology:

The female that was found dead had light discolouration of the liver and the small intestine contained a reddish-black, haemoccult positive, mass. No abnormalities were seen in the animals that survived to study termination.

Any other information on results incl. tables

All animals appeared normal by day 3.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of methoxybutanol was >2000 mg/kg to male and female rats.

Executive summary:

In an acute oral study with male and female Wistar rats, methoxybutanol was dosed orally, by gavage, at 2000 mg/kg in water. Animals were observed daily for a further 14 days and weighed at weekly intervals. On day 15, rats were killed and examined grossly. One female died on the day after dosing.Clinical signs seen in most animals on day 1, included irregular respiration, stupor, coat bristling, flanks drawn in, stilted or uncoordinated gait, ataxia and decreased activity.

All animals appeared normal by day 3 and gained weight during the study. Discolouration of the liver and a reddish-black mass in the small intestine were present in the female that died. No gross abnormalities were seen in the animals that survived to study termination.

The LD50 of methoxybutanol was >2000 mg/kg.