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EC number: 210-431-8 | CAS number: 615-50-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Referenceopen allclose all
- 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 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:
- 2 003
- Bibliographic source:
- CONTACT DERMATITIS; 49, 236-240
- Reference Type:
- publication
- Title:
- Contact dermatitis in hairdressers: the Italian experience
- Author:
- Guerra, L. et al.
- Year:
- 1 992
- Bibliographic source:
- CONTACT DERMATITIS; 26, 101-107
- Reference Type:
- publication
- Title:
- Is PPD a useful screening agent?
- Author:
- Koopmans, A. K.; Bruynzeel, D. P.
- Year:
- 2 003
- Bibliographic source:
- CONTACT DERMATITIS; 48, 89-92
- Reference Type:
- publication
- Title:
- Adverse cutaneous reactions to cosmetic allergens
- Author:
- Goossens, A. et al.
- Year:
- 1 999
- Bibliographic source:
- CONTACT DERMATITIS; 40, 112-113
- Reference Type:
- publication
- Title:
- The spectrum of allergic (cross-)sensitivity in clinical patch testing with 'para amino' compounds
- Author:
- Uter, W. et al.
- Year:
- 2 002
- Bibliographic source:
- ALLERGY; 57, 319-322
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- case report
Test material
- 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
Constituent 1
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.
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