N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide]

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: The study was performed in a test facility that was found to be not reliable. The results have to be used with caution.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide]

EC Number:

245-442-7

EC Name:

N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide]

Cas Number:

23128-74-7

Molecular formula:

C40H64N2O4

IUPAC Name:

N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanamide]

Method

Subjects:

- Number of subjects exposed: 50
- Sex: 22 males, 28 females
- Age: 17-60

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

Results and discussion

Results of examinations:

Not sensitizing

Any other information on results incl. tables

A human repeated insult patch test employing 50 test subjects was conducted with the test rticle. The test material was evaluated as a 10% suspension in PEG-400. The resutls of the induction applications (9, 23-hour occluded patches) are summarized below:

			Number of reactions with scores of
No of reactors	No of reactions	no of patches applied	0	1	2	3	4	5	6	7	8
1	1	400	399	1	0	0	0	0	0	0	0

1-2 slight; 3-4 mild; 5-6 moderate; 7-8 severe

One subject exhibited a mild reaction following the sixth patch application during the induction phase of the study. No other evidence of irritation following patch application was noted throughout the course of the study. Of 2 subjects that showed reactions to the challenge application, only subject #46 was available for a rechallenge for confirmation of these responses. The rechallenge to subject #46 showed no evidence of a skin reaction at 24, 48 or 72 hours after the rechallenge, indicating that the reaction first encountered was transient irritation. The reaction experienced by subject #42 would appear to be a sensitization response due to the severty of the response; but, this fact could not be confirmed at this time due to the unavailability of the subject for rechallenge.

No further evidence of sensitization was noted in the remaining 48 subjects challenged with the test material.