Acetoacetamide

Endpoint summary

Description of key information

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.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

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

Specific details on test material used for the study:

25% Acetoacetamide solution

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

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.

Preliminary study:

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

Sex:

female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat. (dissolved fraction)

Remarks:

25% solution

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available