Registration Dossier
Registration Dossier
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EC number: 221-375-9 | CAS number: 3081-14-9
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: limited but acceptable documented study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
- Principles of method if other than guideline:
- other: acute oral toxicity study
- GLP compliance:
- no
- Test type:
- other: acute oral toxicity study
Test material
- Reference substance name:
- N,N'-bis(1,4-dimethylpentyl)-p-phenylenediamine
- EC Number:
- 221-375-9
- EC Name:
- N,N'-bis(1,4-dimethylpentyl)-p-phenylenediamine
- Cas Number:
- 3081-14-9
- Molecular formula:
- C20H36N2
- IUPAC Name:
- N1,N4-bis(5-methylhexan-2-yl)benzene-1,4-diamine
- Details on test material:
- Santoflex 77 (purity: 96%)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 501, 631, 794, 1000 mg/kg bw
- No. of animals per sex per dose:
- 5 (combined males and females)
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 730 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 690 - 770
- Remarks on result:
- other: Signs of intoxication: reduced appetite and activity (four to six days in survivors), increasing weakness, collapse, and death; gross autopsy (decedents): hemorrhagic areas of the lungs, liver discoloration and acute gastrointestinal inflammation
Any other information on results incl. tables
Mortality
501 mg/kg: male (1/2), female (0/3), combinded (1/5)
631 mg/kg: male (1/3), female (0/2), combinded (1/5)
794 mg/kg: male (1/2), female (2/3), combinded (3/5)
1000 mg/kg: male (3/3, female (2/2), combinded (5/5)
Time of mortality: Two to seven days after test substance application, most deaths occured in four days
Clinical signs:
Reduced appetite and activity (four to six days in survivors), increasing weakness, collapse, and death
Gross autopsy
Decedents: hemorrhagic areas of the lungs, liver discoloration and acute gastrointestinal inflammation
Survivors (10 day): viscera appeared normal
Applicant's summary and conclusion
- Executive summary:
LD50 rat: 730 mg/kg bw
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