Registration Dossier
Registration Dossier
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EC number: 202-111-1 | CAS number: 91-96-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well performed study under the conditions valid in 1974
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: company SOP
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- N,N'-(3,3'-dimethylbiphenyl-4,4'-ylene)di(acetoacetamide)
- EC Number:
- 202-111-1
- EC Name:
- N,N'-(3,3'-dimethylbiphenyl-4,4'-ylene)di(acetoacetamide)
- Cas Number:
- 91-96-3
- Molecular formula:
- C22H24N2O4
- IUPAC Name:
- N,N'-(3,3'-dimethylbiphenyl-4,4'-diyl)bis(3-oxobutanamide)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: SPF - Wistar
- Source: Farbwerke Hoechst , own breeding
- Weight at study initiation: 94 -112 grams
- Fasting period before study: 16 hours
- Housing: plasic cages
- Diet: Altromin 1324 ad libitum
- Water: tap water ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25% suspension in sesame oil - Doses:
- 15 000 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: daily and weighing: one a week
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 15 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 15 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality occured
- Clinical signs:
- other: the behavior of the animals during application and observation period was normal
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Since LD50 > 15000 mg/kg bw the substance has not to be classified for acute oral toxicity.
- Executive summary:
For determination of the acute oral toxicity, 10 female SPF-Wistar rats were administered with a dose of 15000 mg/kg bw by gavage.
During application and the 14 days observation period no animal died. The behaviour of the animals in this time was normal.
Therefore the LD50 of this substance is greater than 15000 mg/kg bw
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