Methyl acetoacetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is comparable to OECD 401 with acceptable restrictions mostly due to reduced reporting in times before GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

BASF-Test

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methyl acetoacetate

EC Number:

203-299-8

EC Name:

Methyl acetoacetate

Cas Number:

105-45-3

Molecular formula:

C5H8O3

IUPAC Name:

methyl 3-oxobutanoate

Details on test material:

- Name of test material (as cited in study report): Acetessigsaeuremethylester (methyl acetoacetate); no further information given in the summary report

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gassner
- Age at study initiation: no data
- Mean weight at study initiation: males: 213 g; females: 177 g
- Fasting period before study:
- Housing: no data
- Diet (e.g. ad libitum): Herilan MRH-Haltung, feed for keeping of mice, rats and hamster Heinrich Eggersmann KG, Rinteln, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- no data

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5 % aqueous formulation

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 31.6; 21.5 and 14.7 %
- Application volume: 10 ml / kg bw

Doses:

3160; 2150 and 1470 mh/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: Weighing was done in the beginning of the study for dose calculation and weekly thereafter. Observation of clinical signs was several times on the day of administration and once daily afterwards with the exception of weekends and on holidays.
- Necropsy of survivors performed: yes

Statistics:

No statistics were performed because it not possible in this case.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 800 mg/kg bw

Based on:

test mat.

Mortality:

3160 mg / kg bw: males: after 1 hour 3 of 5 animals died; afterwards no further animals died; females: after 1 hour 4 of 5 animals died; afterwards no further animals died.
2150 mg / kg bw: males: after 1 hour 1 of 5 animals died; afterwards no further animals died; females: after 1 hour 1 of 5 animals died; afterwards no further animals died.
1470 mg / kg bw: males and females: no animals died.

Clinical signs:

other: 3160 mg / kg bw: appreciably marked irregular respiration, dyspnoe up to 5 hours; weak apathy up to 4 hours; bad general condition up to 5 hours. 2150 mg / kg bw: appreciably marked irregular respiration, dyspnoe up to 4 hours; bad general condition up to

Gross pathology:

Post mortem examination of animals that died showed the following results:
3160 mg / kg bw: 3 males and 4 females and 2150 mg / kg bw: 1 female, 1 male: heart: acute dilatation; acute congestive hyperemia; abdominal organs: no abnormalities detected.
No abnormal findings were observed in survivors sacrificed at the end of the observation period.

Other findings:

No other findings reported.