Registration Dossier
Registration Dossier
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EC number: 202-576-0 | CAS number: 97-36-9
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1980
- Reliability:
- other: not adequate
- Rationale for reliability incl. deficiencies:
- other: Study design does not correspond with EU classification criteria
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
- Deviations:
- no
- Principles of method if other than guideline:
- Test animal: mouse
Route of exposure: i.p.
Examinations/observations: Clinical signs, lethality, body weight - GLP compliance:
- no
- Remarks:
- prior to GLP implementation
- Limit test:
- no
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:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean 22-28 g
- Fasting period before study: 15 - 20 h
- Housing:
- Diet (e.g. ad libitum): Herilan MRH-Haltung; H. Eggersmann KG
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- aqueous 0.5%
- Doses:
- Dose mg/kg 2000 700
Conc. w/v 20 7
Appl. Vol. ml/kg bw 10 10 - No. of animals per sex per dose:
- 5
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 700 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- male
2000 mg/kg bw: 5/5
700 mg/kg bw: 0/5
female
2000 mg/kg bw: 5/5
700 mg/kg bw: 0/5 - Clinical signs:
- 2000 and 700 mg/kg bw:
DYSPNEA, APATHY, ABNORMAL POSITION, ATAXIC GAIT, ATONY, MISSING PAIN REACTION, NARCOSIS LIKE STATE, EXSICCOSIS, WEAK GENERAL STATE
2000 mg/kg bw:
MISSING CORNEAL REFELX, CYANOSIS
700 mg/kg bw:
CONVULSIVE GAIT, COAT RUFFLED - Body weight:
- male
2000 mg/kg bw, initial: 24, day 13: /
700 mg/kg bw: initial: 28, day 13: 33.4
female
2000 mg/kg bw, initial: 22, day 13: /
700 mg/kg bw: initial: 24, day 13: 27.6
Applicant's summary and conclusion
- Conclusions:
- LD50: >700, <2000 mg/kg bw
- Executive summary:
The acute median lethal intraperitoneal dose (LD50) for the mouse was estimated to be:
Male and female combined: >700 and <2000 mg/kg bw
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