Acetoacetamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Study conducted prior to GLP and OECD guideline implementation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Remarks:

Study conducted prior to GLP and OECD guideline implementation.

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acetoacetamide

EC Number:

227-774-4

EC Name:

Acetoacetamide

Cas Number:

5977-14-0

Molecular formula:

C4H7NO2

IUPAC Name:

acetoacetamide

Test material form:

liquid

Details on test material:

Acetoacetamide solution 25 %
white crystaline

Specific details on test material used for the study:

25% Acetoacetamide solution

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

- Source: Hoechst breeding colony;
- Strain: WISKf (SPF 71)
- Weight at study initiation: 99 - 115 grams
- Fasting period before study: 16 hours
- Housing: plastic cages with wood shavings
- Diet: Altromin 1324, ad libitum
- Water: Tap-water, ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

25% solution of acetoacetamide in water

Doses:

15000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: daily; weighing: once a week
- Necropsy of survivors performed: yes

Statistics:

No statistics was performed since only one concentration was applied.

Results and discussion

Preliminary study:

In a pre-test males didn't show a higher sensitivity.

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat. (dissolved fraction)

Remarks:

25% solution

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 3 750 mg/kg bw

Based on:

test mat.

Remarks:

calculated value

Mortality:

no

Clinical signs:

other: tumbling gait, prone position

Gross pathology:

no abnormal findings

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 was determined to be >15000 mg/kg bw.
Calculated for the pure substance: LD50 = 3750 mg/kg bw.

Executive summary:

The acute oral toxicity of the test item was determined by application of 15000 mg/kg bw as a 25% solution in water to 10 female Wistar rats.

After application animals showed tumbling gait and prone position. During the observation period of 14 days body weight gain was not affected and no deaths occured.

Necropsy revealed no abnormal findings. The LD50 was determined to be >15000 mg/kg bw.

Calculated for the pure substance: LD50 = 3750 mg/kg bw.