p-phenylenediamine

Sensitisation data (human)

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: Non-GLP study with well documented materials and methods. Potential confounding variables of hair dye use and semi-permanent use were accounted for in the study design.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2006

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

In this study, the test substance-sensitive patients participated in a serial dilution 48-hr patch test with the test substance using 8 concentrations of the test substance ranging from 1 to 10,000 ppm on the upper back. Petrolatum was applied as control. Three concentrations (50, 100 and 500 ppm the test substance) were also applied to the retroauricular area and on the lateral aspects of the upper arms.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Details on test material:

Standard 1% in white petrolatum from Hermal Trolab (Reinbeck, Germany).

Method

Route of administration:

dermal

Results and discussion

Results of examinations:

SYMPTOMS
- Number of subjects with positive reactions: 14
- Number of subjects with negative reactions: 1 despite having had a highly + reaction 6 years previously
- Number of subjects with equivocal reactions: no data
- Number of subjects with irritating reactions: 7 had contact allergies: fragrance, methyldibromo glutaronitrile, tert-butylphenol formaldehyde resin, disperse orange, thioglycol acid and ammonium persulphate

OTHER RESULTS:
- None ever had a semi-permanent tattoo.
- 12 of the participants have previously colored their hair.
- The mean number of hair colorings performed in a lifetime was 113 (range 8-222), and 10 participants had had a previous allergic reaction to a hair dye product or an allergic reaction to a dye product for eyelashes and brows. There were no differences in the sensitivity (mean sum score) between the group with a hair dye reaction, n = 12, and those with no reaction, n = 3.
- McNemar’s test and Wilcoxon's test comparing the response at the three concentrations, which were applied on the arms, back and behind the ears, showed that there were no regional differences. The mean sum score behind the ears for persons with a previous allergic reaction to a hair dye product was not significantly higher than mean sum score in the same group on the arms and on the back.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, the threshold value for 10% of the tested persons (ED10) based on a weakly positive (+) or stronger reactions for the test substance on the back was 38 ppm; there were no statistically significant differences in sensitivity among the upper back, retroauricular area, and the lateral aspects of the upper arm.

Executive summary:

In this study, the test substance-sensitive patients participated in a serial dilution 48-hr patch test with the test substance using 8 concentrations of the test substance ranging from 1 to 10,000 ppm on the upper back. Petrolatum was applied as control. Three concentrations (50, 100 and 500 ppm the test substance) were also applied to the retroauricular area and on the lateral aspects of the upper arms. Under the conditions of this study, the threshold value for 10% of the tested persons (ED10) based on a weakly positive (+) or stronger reactions for the test substance on the back was 38 ppm; there were no statistically significant differences in sensitivity among the upper back, retroauricular area, and the lateral aspects of the upper arm.