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Toxicological information

Sensitisation data (human)

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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:
2005
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

Constituent 1
Chemical structure
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:
N-(1,3-dimethylbutyl)-N'-phenylbenzene-1,4-diamine
Details on test material:
6PPD

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