2-methyl-p-phenylenediamine

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:

Patch test results in 66 hairdressers 1973-81

Author:

Lynde, C. W.; Mitchell, J. C.

Year:

1982

Bibliographic source:

CONTACT DERMATITIS; 8, 302-307

Reference 2

Reference Type:

publication

Title:

Current pattern and trends in sensitization to hairdressers allergens in Germany

Author:

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

Year:

2000

Bibliographic source:

OCCUP. ENVIRON. DERMATOL.; 48, 55-59

Reference 3

Reference Type:

publication

Title:

Patch test results in hairdressers with contact dermatitis in Greece (1985-1994)

Author:

Katsarou, A. et al.

Year:

1995

Bibliographic source:

CONTACT DERMATITIS; 33, 347-348

Reference 4

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 5

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 6

Reference Type:

publication

Title:

Aktuelle Kontaktallergene

Author:

Frosch, P. J.

Year:

1990

Bibliographic source:

DER HAUTARZT; 41, 129-133

Reference 7

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 8

Reference Type:

publication

Title:

Allergic contact dermatitis in hairdressers: frequency and source of sensitisation

Author:

Iorizzo, M. et al.

Year:

2002

Bibliographic source:

EUR. J. DERMATOL.; 12, 179-182

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

IUPAC Name:

toluene-2,5-diamine

Details on test material:

Several hair dyes were tested, among these:
Toluene-2,5-diamine sulphate (TDAS) CAS 615-50-9

p-phenylenediamine,
p-aminodiphenylamine,
o-nitro-p-phenylenediamine
p-aminophenol
m-aminophenol
resorcinol
p-aminodiphenylamine hydrochloride

Method

Type of population:

occupational

Subjects:

patients who were, or had been hairdresser

Route of administration:

dermal

Details on study design:

patch test

Results and discussion

Results of examinations:

Lynde et al. 1982: 66 dermatitis patients (hairdressers) were patch tested with the North-American patch test standard series and a hairdresser series. 7.5% were positive to toluene-2,5-diamine sulfate, 46% were positive to p-phenylenediamine, 5% to p-aminodiphenylamine, 3% to o-nitro-pphenylenediamine.Uter et al. 2000:597 dermatitis patients (hairdressers), of which 61.8% were current hair dressers, were patch tested in an IVDK multi-centre study in Germany with the patch test standard series and the hairdressers’ series. 21.4% were positive to toluene-2,5-diamine, 18.1% were positive to p-phenylenediamine, 4.0% to p-aminophenol, 3.4% to m-aminophenol. Results from previous periods were also presented - 14.3% were tested positive to toluene-2,5-diamine in 1990-1991 and 16.2% in 1993-1995.Katsarou et al. 1995: 106 dermatitis patients (hairdressers) in Greece (102 females and 4 males) were patch tested with the patch test standard series and the hairdressers’ series. 10.3% were positive to toluene-2,5-diamine sulfate, 30.2% were positive to p-phenylenediamine, 8.4% to o-nitro-p-phenylenediamine, 4.7% to resorcinol, 4.3% to p-aminodiphenylamine, 2.8% to p-aminophenol.Frosch et al. (EECDRG): In a multi-centre study by the European Environmental and Contact Dermatitis Research Group (EECDRG), a total of 809 dermatitis patients (hairdressers) were patch tested with hairdresser allergens in 9 centres. 7.6% were positive to toluene-2,5-diamine sulfate, 14.8% to p-phenylenediamine, 4.1% to o-nitro-p-phenylenediamine, 0.6% to resorcinol and 3.6% to p-aminodiphenylamine hydrochloride.Guerra et al. 1992: In a multi-centre study by the Italian Contact Dermatitis Research Group (GIRDCA), a total of 302 dermatitis patients (hairdressers) (259 females and 43 males) were patch tested with hairdressers’ allergens in 9 Italian centres. 13.2% were positive to toluene-2,5-diamine sulfate, 16.6% to p-phenylenediamine base (in 1989-1990), 7.6% to p-phenylenediamine dihydrochloride (in 1985-1988), 7.9% to o-nitro-p-phenylenediamine, 1.3% to resorcinol and 10.6% to p-aminodiphenylamine.Frosch 1990: In a multi-centre study by the German Contact Dermatitis Group (DKG), 178 dermatitis patients (hairdressers) were patch tested with hairdressers’ allergens in 11 centres. 18.0% were test positive to toluene-2,5-diamine, 8.4% to toluene-2,5-diamine sulfate, 18.0% to p-phenylenediamine base, 0.6% to resorcinol, 1.1% to 3-aminophenol, 2.2% to p-aminodiphenylamine hydrochloride, 3.4% to 4-aminophenol and 6.2% to o-nitro-p-phenylendiamine.Uter 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 hairdressers, 24.8% were test positive to toluene-2,5-diamine, 22.0% to pphenylenediamine,6.1% to p-aminophenol and 3.6% to m-aminophenol.Iorizzo et al. 2002: 209 dermatitis patients (hairdressers) in Italy (182 females and 27 males) were patch tested with a standard series and a hairdressers’ series. 13.8% were positive to toluene- 2,5-diamine sulfate, 36.8% to p-phenylenediamine base, 3.8% to p-aminodiphenylamine, 4.7% to o-nitro-p-phenylenediamine and 0.9% to resorcinol.

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	Positive patch test (%)	Year	Country	Ref
TDAs	66	7.6	1973 - 1981	Canada	Lynde (1982)
TDA	597	21.4	1996 - 1998	Germany	Uter (2000)
TDAs	106	10.3	1985 - 1994	Greece	Katsarou (1995)
TDAs	781	7.6	1988 - 1991	9 Europeancentres	Frosch (EECDRG)
TDAs	302	13.2	1985 - 1990	Italy	Guerra (1992)
TDA TDAs	178	18.0 8.4	1988 - 1989	Germany	Frosch (1990)
TDA	884 (a)	24.8	1995 - 2002	Germany	Uter (2003)
TDAs	209	13.8	2002	Italy	Iorizzo (2002)
Summary	3123	Mean: 16.8%

(a) hairdresser dermatitis patients with dermatitis from hair cosmetics

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.