2-methyl-p-phenylenediamine sulfate

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: Published data; not enough details to assess validity

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Allergic reactions to hairdresser`s series - results of nine European centers

Author:

Frosch, P. J., et al.

Bibliographic source:

EUROPEAN ENVIRONMENTAL AND CONTACT DERMATITIS RESE

Reference 2

Reference Type:

publication

Title:

Contact allergy to ingredients of hair cosmetics in female hairdressers and clients - an 8-year analysis of IVDK data

Author:

Uter, W.; Lessmann, H.; Geier, J.; Schnuch, A.

Year:

2003

Bibliographic source:

CONTACT DERMATITIS; 49, 236-240

Reference 3

Reference Type:

publication

Title:

Contact dermatitis in hairdressers: the Italian experience

Author:

Guerra, L. et al.

Year:

1992

Bibliographic source:

CONTACT DERMATITIS; 26, 101-107

Reference 4

Reference Type:

publication

Title:

Is PPD a useful screening agent?

Author:

Koopmans, A. K.; Bruynzeel, D. P.

Year:

2003

Bibliographic source:

CONTACT DERMATITIS; 48, 89-92

Reference 5

Reference Type:

publication

Title:

Adverse cutaneous reactions to cosmetic allergens

Author:

Goossens, A. et al.

Year:

1999

Bibliographic source:

CONTACT DERMATITIS; 40, 112-113

Reference 6

Reference Type:

publication

Title:

The spectrum of allergic (cross-)sensitivity in clinical patch testing with 'para amino' compounds

Author:

Uter, W. et al.

Year:

2002

Bibliographic source:

ALLERGY; 57, 319-322

Materials and methods

Type of sensitisation studied:

skin

Study type:

case report

Test material

Test material information

Constituent 1

Reference substance name:

toluene-2,5-diamine sulfate

IUPAC Name:

toluene-2,5-diamine sulfate

Details on test material:

Several hair dyes were tested, among these:
Toluene-2,5-diamine (TDA) CAS 95-70-5

p-phenylenediamine
o-nitro-p-phenylenediamine
resorcinol
p-aminodiphenylamine hydrochloride
p-aminophenol
m-aminophenol
p-aminodiphenylamine
p-aminoazobenzene
n-phenyl- p-phenylenediamine

Method

Type of population:

general

Subjects:

Tested dermatitis patients selected due to symptoms or exposure related to cosmetics

Route of administration:

dermal

Details on study design:

patch test

Results and discussion

Results of examinations:

Frosch (EECDRG): In a multi-centre study by the European Environmental and Contact Dermatitis Research Group (EECDRG), a total of 104 dermatitis patients identified as hairdressers’ clients were patch tested with hairdresser allergens in 4 centres. 8.7% were positive to toluene-2,5- diamine sulfate, 19.2% to p-phenylenediamine, 7.7% to o-nitro-p-phenylenediamine, 1.9% to resorcinol and 3.9% to p-aminodiphenylamine hydrochloride.

Uter et al. 2003: In a German multi-centre study by the IVDK, hairdressing cosmetics and hair care products were considered causative of contact dermatitis in a total of 2328 dermatitis patients (92% female). 884 of the cases were currently or had been working as hairdressers. 1217 had not been hairdressers (in the publication called clients). All were patch tested in 1995-2002. Among the non-hairdressers, 13.2% were test positive to toluene-2,5-diamine.

Guerra et al. 1992: 261 dermatitis patients identified as hairdressers’ clients, for whom treatment with hair dyes or permanent wave solutions was suspected to be the cause of the dermatitis (256 females, 5 males), were patch tested in Bologna, Italy with the Italian standards series for patch testing and with a hairdressers’ screening series. 4.6% were test positive to toluene- 2,5-diamine sulfate, 14.7% to p-phenylenediamine, 6.5% to p-aminophenol and 4.2% to m-aminophenol.

Koopmans et al. 2003: 154 dermatitis patients with a positive patch test reaction to p-phenylenediamine were tested further with para compounds frequently used in hair dyes, in Amsterdam, the Netherlands. 9.7% were positive to toluene-2,5-diamine sulfate15% to paminoazobenzene, 3.2% to p-aminophenol, 3.2% to o-nitro-p-phenylenediamine, 2.6% to p-aminodiphenylamine and 0.6% to resorcinol.

Goossens et al. 1999: 475 dermatitis patients for whom contact allergy to cosmetic ingredients had been shown by patch testing in 5 European centres in the UK, Germany and Belgium, were included in a retrospective study. 11 cases (possibly 2.3%) were tested positive to toluene-2,5-diamine, 33 cases to p-phenylenediamine, 8 cases to 2-nitro-p-phenylenediamine, 2 cases to n-phenyl-p-phenylenediamine, 1 case to resorcinol. It was not stated if all patients had been tested with all substances.

Uter et al. 2002: 613 dermatitis patients had been patch tested with the German Contact Dermatitis Group (DKG) para-amino compounds test series. 10.0% were tested positive to toluene-2,5-diamine, 14.1% to p-phenylenediamine, 3.1% to p-aminophenol and 16.2% to paminoazobenzene.

Any other information on results incl. tables

Contact allergy to toluene-2,5-diamine in patch tested dermatitis patients who were, or had been hairdresser. Test substance: toluene-2,5-diamine (TDA) or toluene-2,5-diamine sulphate (TDAs) 1% in petrolatum

Test substance	No. tested patients and selection criteria	Positive patch test (%)	Year	Country	Ref
TDAs	104 Hairdressers’ clients	8.7	1988 - 1991	4 European centres	Frosch (EECDRG)
TDA	1217Dermatitis from hair cosmetics, not hairdressers	13.2	1995 - 2002	Germany	Uter (2003)
TDAs	261Hairdressers’ clients	4.6	1985 - 1990	Italy	Guerra (1992)
TDAs	154Patch-test pos. to PPD	9.7	1996 - 1999	The Netherlands	Koopmans (2003)
TDA	475Contact allergy to cosmetic ingredients	2.3	1996	5 European centres	Goossens (1999)
TDA	613Tested with para amino compounds series	10.0	1995 - 1999	Germany	Uter (2002)
Summary	2824	Mean: 9.5%

Applicant's summary and conclusion

Conclusions:

Results from several diagnostic patch studies in dermatitis patients show a high rate of contact allergy to toluene-2,5-diamine and toluene-2,5-diamine sulphate. The highest rate was found in dermatitis patients being hairdressers (16.8%), followed by dermatitis patients selected due to symptoms or exposure related to cosmetics (9.5%), and unselected dermatitis patients (2.4%). The rate of contact allergy to toluene-2,5-diamine sulphate in hairdressers (not patients) was 2-2.7%.

Due to different selection criteria and different patch test substances used, conclusions cannot be drawn concerning the trend over time of contact allergy to toluene-
2,5-diamine and toluene-2,5-diamine sulphate. The results indicate that patch test reactivity is higher to toluene-2,5-diamine than toluene-2,5-diamine sulphate.

In all publications (except ref Holm), results from patch testing with p-phenylenediamine is given and in several publications also results from tests with additional hair dye substances. In the majority of publications, the rate of contact allergy to p-phenylenediamine was the highest, followed closely by toluene-2,5-diamine, both generally much higher than to other hair dye substances. In some publications, the order between p-phenylenediamine and toluene-2,5-diamine was reversed.

The results do not allow further conclusions concerning concomitant patch test reactions -whether they were the result of multiple sensitisation, or if the result of cross-reactivity to different compounds was due to chemical similarity. Conclusions concerning cross-reactivity require animal studies where induction and elicitation are controlled.

Executive summary:

Results from several diagnostic patch studies in dermatitis patients and non patient show a high rate of contact allergy to toluene-2,5-diamine and toluene-2,5-diamine sulphate. The results were conducted in several European countries between 1970 and 2002 and involved a total of 20954 patients, which were or had been hairdresser, or hairdresser trainee or hairdresser's client or patient with contact allergy to cosmetic ingredients.

The highest rate was found in dermatitis patients being hairdressers (16.8%), followed by dermatitis patients selected due to symptoms or exposure related to cosmetics (9.5%), and unselected dermatitis patients (2.4%). The rate of contact allergy to toluene-2,5-diamine sulphate in hairdressers (not patients) was 2-2.7%.

Due to different selection criteria and different patch test substances used, conclusions cannot be drawn concerning the trend over time of contact allergy to toluene-2,5-diamine and toluene-2,5-diamine sulphate.