Registration Dossier
Registration Dossier
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EC number: 212-344-0 | CAS number: 793-24-8
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- other: review
- Rationale for reliability incl. deficiencies:
- other: review
Data source
Reference
- Reference Type:
- publication
- Title:
- N-(1,3-Dimethylbutyl)-N'-phenyl-1,4-phenylenediamine, CAS no.: 793-24-8
- Author:
- OECD SIDS
- Year:
- 2 005
- Bibliographic source:
- UNEP Publications 2005
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- other: skin sensitizing studies with humans, case reportes
- GLP compliance:
- no
Test material
- Reference substance name:
- N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine
- EC Number:
- 212-344-0
- EC Name:
- N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine
- Cas Number:
- 793-24-8
- Molecular formula:
- C18H24N2
- IUPAC Name:
- N1-(4-methylpentan-2-yl)-N4-phenylbenzene-1,4-diamine
- Details on test material:
- 6PPD
Constituent 1
Method
- Route of administration:
- dermal
Results and discussion
- Results of examinations:
- 6PPD is skin sensitzing in humans
Any other information on results incl. tables
OECD SIDS 2005:
"A range of older studies performed by chemical industry report from patch-tests in humans applying a repeated insult patch test (method of Shelanski) or a modified Schwartz patch test. In healthy volunteers not previously exposed to test rubber formulations, no sensitization or only a low sensitization rate to 6PPD was noted, while the sensitization rate was much higher in persons who had been previously sensitized to rubber samples.
Sensitization in the course of repeated insult patch-tests (induction by 15 repeated treatments followed by one challenge application) was reported for groups of 17/50 and 16/50 individuals (Industrial Biological Laboratories Inc., 1964) as well as for 4/50 and 5/50 individuals (Industrial Biology Laboratories Inc. 1964c, Product Investigations Inc. 1976). Otherwise under similar test conditions groups of 50 volunteer subjects (not previously exposed to p-phenylenediamine- derivatives or to test rubber formulations) all showed negative patch-test reactions to 6PPD in 3 studies (Industrial Biology Laboratories Inc. 1964b; Food and Drug Research Laboratories Inc., 1972; Monsanto Chemical Co., not dated, b).
Positive results to 6PPD were also noted in modified Schwartz patch tests for 3/10, 5/10, 9/10 and 3/5 volunteers subjects, respectively, who had been previously sensitized to rubber samples (Industrial Biology Laboratories Inc., 1963 a, 1963 b, 1963 c, 1964 d.
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.
