Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: acceptable, well-documented study report, which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
other: modified Draize skin sensitization study
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(1,4-dimethylpentyl)-N'-phenylbenzene-1,4-diamine
EC Number:
221-374-3
EC Name:
N-(1,4-dimethylpentyl)-N'-phenylbenzene-1,4-diamine
Cas Number:
3081-01-4
Molecular formula:
C19H26N2
IUPAC Name:
N1-(5-methylhexan-2-yl)-N4-phenylbenzene-1,4-diamine
Details on test material:
Santoflex 14

Method

Type of population:
general
Controls:
control group of volunteers not included
Route of administration:
dermal

Results and discussion

Results of examinations:
There was no evidence of allergic contact sensitization to Santoflex 14, at 1 % in petrolatum (0/80)

Any other information on results incl. tables

There was no evidence of allergic contact sensitization to Santoflex 14, at 1 % in petralatuin (0/80).

There were no product related drop-outs.

Applicant's summary and conclusion