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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

Constituent 1
Chemical structure
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 levelsopen allclose all
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:
tumbling gait, prone position
Body weight:
Initial: 99 - 115 grams
after 7 days: 122 - 140 grams
after 14 days: 142 - 165 grams
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.

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