Registration Dossier
Registration Dossier
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EC number: 202-576-0 | CAS number: 97-36-9
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 OECD and GLP guideline implementation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
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
Test material
- Reference substance name:
- 2',4'-dimethylacetoacetanilide
- EC Number:
- 202-576-0
- EC Name:
- 2',4'-dimethylacetoacetanilide
- Cas Number:
- 97-36-9
- Molecular formula:
- C12H15NO2
- IUPAC Name:
- 2',4'-dimethylacetoacetanilide
- Details on test material:
- - Name of test material (as cited in study report): Acetessig-m-xylidid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Fasting period before study: 15 - 20 h
- Observation period: 14 d
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- aqueous 0.5%
- Details on oral exposure:
- Dose:
4640, 3160, 2610, 2150, 1780, 1470, 1210, 1000, 681 mg/kg bw
Concentration in vehicle:
46.4, 31.6, 26.1, 21.5, 17.8, 14.7, 12.1, 10.0, 6.8 % (W/V)
DOSE VOLUME APPLIED:
10 ml/kg - Doses:
- 4640, 3160, 2610, 2150, 1780, 1470, 1210, 1000, 681 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Statistics:
- Probit
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 995 mg/kg bw
- Based on:
- test mat.
- Mortality:
- male:
4640 mg/kg bw: 4/5
3160 mg/kg bw: 4/5
2610 mg/kg bw: 3/5
2150 mg/kg bw: 3/5
1780 mg/kg bw: 1/5
1470 mg/kg bw: 3/5
1210 mg/kg bw: 0/5
1000 mg/kg bw: 2/5
681 mg/kg bw: 0/5
female:
4640 mg/kg bw: 4/5
3160 mg/kg bw: 3/5
2610 mg/kg bw: 4/5
2150 mg/kg bw: 3/5
1780 mg/kg bw: 2/5
1470 mg/kg bw: 3/5
1210 mg/kg bw: 1/5
1000 mg/kg bw: 1/5
681 mg/kg bw: 0/5 - Clinical signs:
- other: DYSPNEA, APATHY, ABNORMAL POSITION, ATAXIC GAIT, ATONY, MISSING PAIN REACTION, NARCOSIS LIKE STATE, CONVULSIVE GAIT, COAT RUFFLED, SKIN REDDISH, EXSICCOSIS, LACRIMATION, WEAK GENERAL STATE
- Gross pathology:
- animals died:
cardiac dilatation and hyperemia
liver: adipose degeneration
urinary bladder: haemorrhage
urine: blood-coloured
kidneys: loam-coloured
lung: sporadic oedematous
animals killed:
no abnormal findings
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- LD50: 1995 mg/kg bw
- Executive summary:
The acute median lethal oral doses (LD50) for the rat were estimated to be:
Male and female combined: 1995 mg/kg bw
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