Acetoacetamide

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: well performed research 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:

other: company guideline similar to OECD 401

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

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

Details on test material:

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

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- 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

Remarks:

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

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: tumbling gait, prone position

Gross pathology:

no abnormal findings

Any other information on results incl. tables

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

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

LD50: >15000 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.