Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 2g. Reference from collection of data in review article.

Data source

Reference
Reference Type:
review article or handbook
Title:
Aniline—A ‘Historical’ Contact Allergen? Current Data from the IVDK and Review of the Literature
Author:
Uter W., Stropp G., Schnuch A. and Lessmann H.
Year:
2007
Bibliographic source:
Ann. Occup. Hyg., Vol. 51, No. 2, pp. 219–226

Materials and methods

Type of sensitisation studied:
skin
Study type:
other: Study on patients with dermatitis and already sensitized to p-phenylenediamine.
Test guideline
Qualifier:
no guideline required
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Comparison to other anilines: N,N-dimethylaniline and p-toluidine (4-methylaniline).

Method

Type of population:
other: 160 patients with contact allergy to p-phenylenediamine
Controls:
Not included, reaction to N-methylaniline was compared to reaction to other anilines.
Route of administration:
dermal

Results and discussion

Results of examinations:
None of 40 patients positive when tested with 5% N-methylaniline and N,N-dimethylaniline; 37/58 patients positive when tested with 2% p-toluidine.

Applicant's summary and conclusion

Conclusions:
In contrast to 4-methylaniline, N-methlaniline did not induce an allergic reaction in patients hypersensitive to p-phenylenediamine.