Registration Dossier
Registration Dossier
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EC number: 239-816-9 | CAS number: 15721-78-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 23 January to 6 June 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Conducted in a similar manner to validated testing guidelines. Study pre-dates GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Principles of method if other than guideline:
- One group of ten (5 male & 5 female) albino rats of the Sherman-Wistar Strain were employed in this study. Each animal was weighed and dosed by direct administration of bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine into the stomach by means of a syringe and dosing needle. Following 14 days observation period during which time the rats were observed for signs of toxicity and mortalities.
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine
- EC Number:
- 239-816-9
- EC Name:
- Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine
- Cas Number:
- 15721-78-5
- Molecular formula:
- C28H43N
- IUPAC Name:
- 4-(2,4,4-trimethylpentan-2-yl)-N-[4-(2,4,4-trimethylpentan-2-yl)phenyl]aniline
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Batch No.: not specified
- Purity: not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sherman-Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200-300 gm
- Fasting period before study: 24 hours
- Water (e.g. ad libitum): ad libitum
no additional data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25% w/v
No additional data - Doses:
- 5.0 gm/kg
- No. of animals per sex per dose:
- 5 males/5 females
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily. The body weight in the preliminary study was recorded immediately.
-Necropsy of survivors performed: yes, Gross pathologic examination revealed nothing remarkable.
-Other examinations performed: clinical signs, body weight - Statistics:
- None stated
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities were observed.
- Clinical signs:
- other: There were no unusual behvioral signs noted.
- Gross pathology:
- Gross pathologic examination revealed nothing remarkable.
- Other findings:
- No information provided
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine when studied in male and female albino rats has an acute oral LD50 greater than 5.0 gm/kg.
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