Registration Dossier
Registration Dossier
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EC number: 221-375-9 | CAS number: 3081-14-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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 dermal toxicity study
- GLP compliance:
- no
- Test type:
- other: acute dermal 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:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24 hours
- Doses:
- 1260, 2000, 3160, 5010, 7940 mg/kg bw
- No. of animals per sex per dose:
- 1 per dose
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 160 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: death occured at 5010 mg/kg bw and higher, clinical signs like reduced appetite and activity (survivors), increased weakness, collapse and death (2 to 3 days) occured after application
Any other information on results incl. tables
Mortality
1260 mg/kg: male -, female (0/1), combinded (0/1)
2000 mg/kg: male (0/1), female -, combinded (0/1)
3160 mg/kg: male -, female (0/1), combinded (0/1)
5010 mg/kg: male (1/1), female -, combinded (1/1)
7940 mg/kg: male -, female (1/1), combinded (1/1)
Time of mortality: 2 to 3 days after test substance application
Clinical signs:
Reduced appetite and activity (three to seven days in survivors), increasing weakness, collapse, and death
Gross autopsy findings:
Decedents: lung hyperemia, liver discoloration, enlarged gall bladder, and gastrointestinal inflammation
Survivors (14 days): animal # 1: viscera appeared normal, animals #2 and #3: slight discoloration of liver and kidneys
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
