Ethylene diacetoacetate

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: Well performed OECD and GLP 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:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Principles of method if other than guideline:

A limit test at a dose level of 5000 mg/kg was carried out.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethylene diacetoacetate

EC Number:

226-724-9

EC Name:

Ethylene diacetoacetate

Cas Number:

5459-04-1

Molecular formula:

C10H14O6

IUPAC Name:

ethane-1,2-diyl bis(3-oxobutanoate)

Details on test material:

- Name of test material (as cited in study report): Acetessigsäure-glykolester

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
- Age at study initiation: males: about 7 weeks; females: 9 weeks
- Weight at study initiation: average: males 194 Grams; females 189 Grams
- Fasting period before study: 16 hours
- Housing: air conditioned rooms; macrolone cages with groups of 5 animals
- Diet (e.g. ad libitum): rat diet Altromin 1324 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimatisation period: at leats 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-3 °C
- Humidity (%): 50+-20 %
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50% (w/v)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males
5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

1 of 5 females
0 of 5 males

Clinical signs:

other: squatting posture, flanks pinched in, irregular respiration, stilted gait, lateral position, prone position, decreased spontaneous activity, coat bristling, increased respiratory rate

Any other information on results incl. tables

No abnormal finding in animals sacrificed at the end of the observation period. One female found dead at day 2 could not be examinined due to cannibalism.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The LD50 for acute orale toxicity in rats is > 5000 mg/kg bw.

Executive summary:

Acetessigsäure-glykolester was tested for acute oral toxicity following the protocol of OECD 401 (limit test). A single dose of 5000 mg/kg bw was tested by administering a 50% (W/V) emulsion in water once per oral gavage to 5 male and 5 female Wistar rats. Median body weights were 194 g (m) and 189 g (f). 16 h before until 2 h after administration food was withdrawn. The post administrational observation period was 14 d. During this time rats were fed with standard diet and tap water.

During the observation period lethality was 1 (f) out of 10 animals (m and f).These findings demonstrate that oral LD50 exceeds 5000 mg/kg bw.