Registration Dossier
Registration Dossier
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EC number: 701-385-4 | CAS number: -
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:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction products of Benzeneamine, N-phenyl- with nonene (branched)
- EC Number:
- 701-385-4
- Cas Number:
- 36878-20-3
- Molecular formula:
- C21H29N - C30H47N (main constituents)
- IUPAC Name:
- Reaction products of Benzeneamine, N-phenyl- with nonene (branched)
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Source of report or test material: UniroyalChemical Company Middlebury, CT
Label: Polylite
Description: Dark brown liquid
The test article was stored in the container provided by the sponsor at ambient room temperature and humidity
Specific gravity: 0.93
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: No data
- Weight at study initiation: 284-297g for males and 235-255 g for females.
- Fasting period before study: 16-24h
- Housing: 5 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): controlled
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: Aug 7, 1981 To: Aug 21, 1981
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- The rats were observed twice daily for 14 days for mortality and toxicity. Body weights were recorded pretest, weekly and at death. All rats were examined for gross pathology.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality observed
- Mortality:
- None
- Clinical signs:
- other: Anogenital area stained brown (two females during two days) Chrornodacryorrhea (each one male and one female during one day) Dyspnea (one male during two days) Ptosis (one female during one day) Chromorhinorrhea (one male during one day)
- Gross pathology:
- One animal had parts of the intestine with a yellow coloration.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No mortality was observed at a single dose of 5000 mg/kg bw.
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