Sodium methanolate

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium methanolate

EC Number:

204-699-5

EC Name:

Sodium methanolate

Cas Number:

124-41-4

Molecular formula:

CH4O.Na

IUPAC Name:

sodium methanolate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna (UK) Limited, Wyton, Huntingdon
- Age at study initiation: five to eight weeks old
- Weight at study initiation: 122 - 145 g males; 120 - 142 g females
- Fasting period before study: overnight
- Housing: in groups of up to five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24
- Humidity (%): 50-68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 100-200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw

Doses:

1000, 1260, 1587 and 2000 mg/kg bw

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:
observations: 1 and 4 hours after dosing and subsequently once daily for 14 days
weighing: on the day of treatment (day 0), day 7 and 14, or at death
- Necropsy of survivors performed: yes

Statistics:

Probit Analysis

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 687 mg/kg bw

95% CL:

>= 1 464 - <= 2 406

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

1 844 mg/kg bw

95% CL:

>= 1 395 - <= 2 437

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

1 682 mg/kg bw

95% CL:

>= 1 218 - <= 2 323

Mortality:

One animal was found dead one hour after treatment. All other deaths were noted one to six days after treatment.

Clinical signs:

other: All animals: hunched posture, pilo-erection, decreased respiration rate (1 to 4 h after dosing). Some of the symptoms were observed up to days 6 to 9 in surviving animals of the 1587 mg/kg bw group and up to day 11 in those of the high dose group. Additio

Gross pathology:

Common abnormalities of animals that died during the study: red lungs, pale or dark or patchy pallor of livers. At 1587 and 2000 mg/kg bw: severe haemorrhage and rugae of the glandular gastric epithelium. Occasional adherence of stomach to the liver. In the surviving animals killed at termination occasional findings were white foci in the non-glandular gastric epithelium and adherence of the stomach to the liver.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute oral median lethal dose (LD50) and the 95% confidence limits of the test material in the Sprangue-Dawley CFY strain rat were calculated by the probit method to be:
All animals: 1687 (1464 - 2406) mg/kg bodyweight
Males only: 1844 (1395 - 2437) mg/kg bodyweight
Females only: 1682 (1218 - 2323) mg/kg bodyweight