Registration Dossier
Registration Dossier
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EC number: 202-131-0 | CAS number: 92-15-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD andf GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Reference substance name:
- 2'-methoxyacetoacetanilide
- EC Number:
- 202-131-0
- EC Name:
- 2'-methoxyacetoacetanilide
- Cas Number:
- 92-15-9
- Molecular formula:
- C11H13NO3
- IUPAC Name:
- N-(2-methoxyphenyl)-3-oxobutanamide
- Details on test material:
- - Name of test material (as cited in study report): P0004 or Acetoacet-o-anisidide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD (SD) BR VAF plus
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- weight range of 108 to 135 g; four to six weeks of age. All rats were acclimated to the experimental environment for a period of eight days prior to the start of the main study.
The rats were allocated to cages within the treatment groups. They were housed in groups of up to five rats of the same sex in metal cages with wire mesh floors.
A standard laboratory rodent diet (Biosure LAD1) and domestic quality potable water were provided ad libitum. Access to food only was prevented overnight prior to and approximately 4 hours after dosing.
The mean daily minimum and maximum temperatures of the animal room were 20 °C and 22°C respectively and the mean daily relative humidity value was 59% R.H. The rate of air exchange was maintained at apporoximately 15 air changes/hour. Lighting was controlled by means of a time switch to provide 12 hours artificial light in each 24-hour period.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Doses:
- 1260, 1600, 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males
5 females - Control animals:
- no
- Statistics:
- LD50 was calculated using the method of Finney (1971) Probit Analysis
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 637 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 423 - 1 911
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 638 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 350 - 2 011
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 635 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 326 - 2 053
- Mortality:
- male
1260 mg/kg bw.: 1/5
1600 mg/kg bw.: 3/5
2000 mg/kg bw.: 3/5
female
1260 mg/kg bw.: 0/5
1600 mg/kg bw.: 2/5
2000 mg/kg bw.: 5/5 - Clinical signs:
- other: Pilo-erection was observed in all rats within 10 minutes of dosing and troughout the remainder of day 1. This finding was accompanied on day 1 and/or at later intervals by: decreased respiratory rate, ptosis and pallor of extremities in all rats; abnormal
- Gross pathology:
- Autopsy of the rats that died revealed pale kidneys, pale and patchy livers, congested lungs and congested blood vessels in the small intestine in two males and one female rat dosed at 2000 mg/kg, and a pale spleen and congested blood vessels in the large intestine in two male rats dosed at 2000 mg/kg bodyweight. No other macroscopic abnormalities were observed. Terminal autopsy findings in surviving rats were normal
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- LD50: 1635 mg/kg bw
- Executive summary:
The acute median lethal oral doses (LD50) for the rat were estimated to be:
Male and female combined: 1637 mg/kg bw
Male: 1638 mg/kg bw
Female: 1635 mg/kg bw
Although Acetoacetanilide congeners are suspected to form methemoglobin no definite indications for MetHb formation were observed.
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