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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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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: Acceptable well documented study report, which meets basic scientific principles. Study was conducted prior to GLP and OECD guideline implementation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Company guideline similar to OECD 401
Deviations:
not applicable
GLP compliance:
no
Remarks:
prior to GLP implementation
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Acetoacetanilide
EC Number:
202-996-4
EC Name:
Acetoacetanilide
Cas Number:
102-01-2
Molecular formula:
C10H11NO2
IUPAC Name:
3-oxo-N-phenylbutanamide
Details on test material:
- Name of test material (as cited in study report): Acetoacet anilide

Test animals

Species:
rat
Strain:
other: albino
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Age: young adults
- Weight: 200-300 g
- Caging: Animals on the same dosage level where placed in a common cage
- Diet/water: water and food, ad libitum
- Animals were fasted for 24hrs prior to the oral administration of the test item

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Doses:
4.0, 5.0, 6.4, 8.0, 10.0, 12.6, 16.0 g/kg bodyweight (females)
4.0, 5.0, 6.4, 8.0, 10.0, 12.6, 16.6 g/kg bodyweight (males)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Observation: daily for a two week period

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD0
Effect level:
4 other: g/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
5.4 other: g/kg bw
95% CL:
4.7 - 6.2
Sex:
female
Dose descriptor:
LD100
Effect level:
8 other: g/kg bw
Sex:
male
Dose descriptor:
LD0
Effect level:
4 other: g/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
6.5 other: g/kg bw
95% CL:
5.3 - 8
Sex:
male
Dose descriptor:
LD100
Effect level:
12.6 other: g/kg bw
Mortality:
male
4000 mg/kg bw: 0/5
5000 mg/kg bw: 1/5
6400 mg/kg bw: 2/5
8000 mg/kg bw: 4/5
10000 mg/kg bw: 5/5
12600 mg/kg bw: 5/5
16600 mg/kg bw: 5/5

female
4000 mg/kg bw: 0/5
5000 mg/kg bw: 2/5
6400 mg/kg bw: 4/5
8000 mg/kg bw: 5/5
10000 mg/kg bw: 5/5
12600 mg/kg bw: 5/5
16000 mg/kg bw: 5/5
Clinical signs:
other: male 4000 mg/kg bw.: lethargy, tremors 5000 and 6400mg/kg bw.: lethargy, tremors, cyanotic extremities 8000 and 10000mg/kg bw.: lethargy, tremors, cyanotic extremities, coma 12600 and 16000 mg/kg bw.: labored breathing, tremors, coma female 4000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Data support conclusion that lethality is caused by MetHb formation. With respect to MetHb forming substances rats are known to react with lower sensitivity than humans. Based on LD50 values of 5400 or 6500 mg/kg bw for female or male rats, the human acute toxic dose is estimated to be not higher than 2000 mg/kg bw.
Executive summary:

LD50, male: 6500 mg/kg body weight

LD50, female: 5400 mg/kg body weight