Hair Dye Chemical Sensitization
Hair Dye Chemical Sensitization
Hair Dye Chemical Sensitization
The SCCS adopted this memorandum at its 18th Plenary meeting of 26 February 2013
SCCS/1509/13
About the Scientific Committees Three independent non-food Scientific Committees provide the Commission with the scientific advice it needs when preparing policy and proposals relating to consumer safety, public health and the environment. The Committees also draw the Commission's attention to the new or emerging problems which may pose an actual or potential threat. They are: the Scientific Committee on Consumer Safety (SCCS), the Scientific Committee on Health and Environmental Risks (SCHER) and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and are made up of external experts. In addition, the Commission relies upon the work of the European Food Safety Authority (EFSA), the European Medicines Agency (EMA), the European Centre for Disease prevention and Control (ECDC) and the European Chemicals Agency (ECHA). SCCS The Committee shall provide opinions on questions concerning all types of health and safety risks (notably chemical, biological, mechanical and other physical risks) of nonfood consumer products (for example: cosmetic products and their ingredients, toys, textiles, clothing, personal care and household products such as detergents, etc.) and services (for example: tattooing, artificial sun tanning, etc.). Scientific Committee members Jrgen Angerer, Ulrike Bernauer, Claire Chambers, Qasim Chaudhry, Gisela Degen, Elsa Nielsen, Thomas Platzek, Suresh Chandra Rastogi, Vera Rogiers, Christophe Rousselle, Tore Sanner, Jan van Benthem, Jacqueline van Engelen, Maria Pilar Vinardell, Rosemary Waring, Ian R. White Contact European Commission Health & Consumers Directorate D: Health Systems and Products Unit D3 - Risk Assessment Office: B232 B-1049 Brussels [email protected]
ISBN 978-92-79ND-
The opinions of the Scientific Committees present the views of the independent scientists who are members of the committees. They do not necessarily reflect the views of the European Commission. The opinions are published by the European Commission in their original language only. http://ec.europa.eu/health/scientific_committees/consumer_safety/index_en.htm
SCCS/1509/13
ACKNOWLEDGMENTS
Dr. W. Lilienblum Dr. E. Nielsen Prof. T. Platzek Dr. S.C. Rastogi Dr. C. Rousselle Prof. T. Sanner Dr. J. van Benthem Prof. M.P. Vinardell Dr. I.R. White External experts Dr. Mona-Lise Binderup
(rapporteur)
Keywords:
Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), memorandum on hair dye chemical sensitisation, 26 February 2013
SCCS/1509/13
A Memorandum on hair dye substances and their sensitising properties adopted during the 10th Plenary of the SCCP on 19 December 2006, summarised the evaluation on the 48 hair dye substances that had been assessed by the SCCP at that time. 27 of the dyes were noted to fulfil the EU criteria for classification as skin sensitizers (R43). Additionally, 10 of the 27 classifiable hair dye substances were categorised as extreme sensitizers, 13 as strong and 4 as moderate sensitizers. The SCCP stated that hair dye substances which fulfil the criteria for classification as R43 may not be safe for consumers and that this is particularly so for hair dye substances categorised as extreme and strong sensitizers. It was necessary to write the Memorandum as the assessment of the safety of hair dyes has been in terms of general toxicology rather than sensitization potential. Hence, hair dye chemical X is safe for use at Y% in hair dyes intended for the consumer apart from its potential to cause skin sensitization. The response to the above Memorandum by the European Commission (29 March 07) was: 1. The Commission services will now extend their assessment in order to minimise possible risks of allergic reactions caused by hair dyes. 2. Epidemiological studies are necessary to examine the extent of skin allergies to hair dyes in the EUs population. 3. Threshold values for sensitizers of high concern need to be determined to take appropriate measure on a possible decrease of exposure.
An updated review of the sensitizing potency of the hair dye chemicals now evaluated by the SCCS, the former SCCP and SCCNFP, is below (which should be considered as indicative, as evaluations are ongoing). The SCCS confirms the views expressed in the earlier Memorandum, that hair dye substances which fulfil the criteria for classification as R43 (now Skin Sens 1 H317 according to CLP) may not be safe for consumers and that this is particularly so for hair dye substances categorised as extreme and strong sensitizers.
13 23 20 24 + 5 29
Table 1. Hair dye substances assessed by the SCCS and the former SCCP and SCCNFP concerning their skin sensitising property, based on submissions by industry. Results from studies performed by OECD guideline methods (LLNA, GPMT and Buehler test). Typically, results from one study per method are displayed. The substances fulfilling the criteria for
SCCS/1509/13
classification as skin sensitiser (R43, Skin Sens 1 H317 according to CLP) were categorised according to their sensitising potency (Memorandum on hair dye substances and their skin sensitising properties, SCCP 2006; Memorandum on classification and categorisation of skin sensitisers and grading of test reactions, SCCP 2005). If data from more than one method is given, the data used for categorisation is in bold letters
COLIPA n INCI name (CAS n) Common name in italic Sensitising potency category, based on results from LLNA or guinea pig assays LLNA EC3 value (%) Guinea pig assay GPMT: i.d. induction conc (%)/incidence of sens (%) Buehler test: topical induction conc (%)/incidence of sens (%) 0.31 GPMT 0.1/100 (modified method) SCCS/1390/10 References
A5
Toluene-2,5-diamine (95-70-5)
Extreme
A7 A8
Extreme Moderate ?
0.06 ? ?
A9
N-Phenyl-p-phenylenediamine (101-54-2; 2198-59-6, hydrochloride; 4698-29-7, sulfate) Resorcinol (108-46-3) 4-Chlororesorcinol (95-88-5) m-Aminophenol (591-27-5; 51-81-0, hydrochloride; 68239-81-6, sulfate; 38171-54-9, sodium salt) p-Aminophenol (123-30-8, free base) (51-78-5, HCl)
Extreme
0.02
SCCP/0991/06
A16
Non-guideline tests indicating strong sens potency Non-guideline tests, not conclusive -
SCCS/1409/11
A17
1-Naphthol (90-15-3)
1.3
SCCP/1123/07
A18 A19
Moderate Moderate
3.4 2.8
SCCS/1365/10 SCCS/1366/10
SCCS/1509/13
COLIPA n
Sensitising potency category, based on results from LLNA or guinea pig assays
Guinea pig assay GPMT: i.d. induction conc (%)/incidence of sens (%) Buehler test: topical induction conc (%)/incidence of sens (%)
References
p-Methylaminophenol (150-75-4) Hydroxybenzomorpholine (2602157-8) 4-Amino-2-hydroxytoluene (283595-2) 2-Methyl-5hydroxyethylaminophenol (5530296-0) 1,2,4-Trihydroxybenzene (533-73-3) Phenyl methyl pyrazolone (89-25-8) 2,4-Diaminophenoxyethanol HCl (66422-95-5) 3-amino-2,4-dichlorophenol (61693-42-3; 61693-43-4, hydrochloride)) 2-Methylresorcinol (608-25-3) N,N-bis(2-Hydroxyethyl)-pphenylenediamine sulfate (5438116-7, sulfate) Tetraaminopyrimidine (5392-28-9, sulfate)
Moderate Not classifiable Strong Not classifiable Extreme Strong Moderate Moderate
2.2
GPMT 1/0 -
0.44 no value
Buehler 100/10 -
A44 A50
Moderate Strong
50 <0.25 *; 1.04 No value. Should have been tested at higher conc. or in other vehicle 1.45 1.55
SCCP/1206/08 SCCP0983/06
A53
Insufficient testing
SCCP/1118/07
A74 A75
Strong Strong
SCCP/0895/05 SCCS/1400/11
SCCS/1509/13
COLIPA n
Sensitising potency category, based on results from LLNA or guinea pig assays
Guinea pig assay GPMT: i.d. induction conc (%)/incidence of sens (%) Buehler test: topical induction conc (%)/incidence of sens (%)
References
A79
1,3-Bis-(2,4-diamino-phenoxy)propane HCl (81892-72-0, free base; 74918-21-1, HCl) Hydroxyethyl-p-phenylenediamine sulphate (93841-25-9) 2-Amino-4hydroxyethylaminoanisole (8376347-7)
Moderate
14.7
SCCP/1098/07
A80 A84
0.57 No value. Should have been tested at higher conc. < 0.5 *
SCCS/1310/10 SCCS/1250/09
A98
Strong
SCCS/1269/09
A99
25 *; no value.
SCCP/1034/06
A101
2,6-Dimethoxy-3,5-pyridinediamine HCl (85679-78-3, free base; 5621628-5, hydrochloride) Dihydroxyindole (3131-52-0) 5-Amino-4-chloro-o-cresol HCl (110102-85-7)
1.25
GPMT 1/15
SCCP/0908/05
A111 A117
GPMT 0.1/0 -
SCCP/0952/05 SCCP/1120/07
A121
Strong
GPMT 1/90
SCCS/1244/09
SCCS/1509/13
COLIPA n
Sensitising potency category, based on results from LLNA or guinea pig assays
Guinea pig assay GPMT: i.d. induction conc (%)/incidence of sens (%) Buehler test: topical induction conc (%)/incidence of sens (%)
References
A128
6-Hydroxyindole (2380-86-1)
Extreme
SCCP/0947/05
A129
Isatin (91-56-5)
Extreme
SCCP/0876/05
A130
6-Methoxy-2-methylamino-3aminopyridine HCl (83732-72-3, 2HCl; 90817-34-8, HCl) 2-Amino-3-hydroxypyridine (16867-03-1) 2,6-Diaminopyridine (141-86-6) 2,6-Dihydroxyethylaminotoluene (149330-25-6) 2,5,6-Triamino-4-pyrimidinol sulfate (1603-02-7) Dihydroxyindoline HBr (29539-035)
Strong
5.6
GPMT 1/90
SCCP/1121/07
A147
SCCNFP/0669/03
A153 A154
1-Acetoxy-2-methoxynaphthalene (5697-02-9) 1-Hydroxyethyl-4,5-diamino pyrazole sulfate (155601-30-2) Strong No value. Should have been tested at higher conc.
SCCS/1509/13
COLIPA n
Sensitising potency category, based on results from LLNA or guinea pig assays
Guinea pig assay GPMT: i.d. induction conc (%)/incidence of sens (%) Buehler test: topical induction conc (%)/incidence of sens (%)
References
A155
Not classifiable
SCCP/1142/07
A156 A157
2-Methyl-1-naphthol (7469-77-4) Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1) (223398-02-5) 2-Amino-5-ethylphenol HCl (149861-22-3) 2,3diaminodihydropyrazolopyrazolone dimethosulfonate (857035-95-1)
1.28 no value
Buehler 5/20 -
SCCP/1163/08 SCCS/1435/11
A158 A159
6.6
SCCS/1442/11
Submission I to be evaluated
B1
Moderate
GPMT 5/100
SCCP/1160/08
B5
SCCP/1161/08
B7
SCCS/1448/11 SCCP/0683/03
SCCS/1509/13
COLIPA n
Sensitising potency category, based on results from LLNA or guinea pig assays
Guinea pig assay GPMT: i.d. induction conc (%)/incidence of sens (%) Buehler test: topical induction conc (%)/incidence of sens (%)
References
B34
N,N-bis(Hydroxyethyl)-2-nitro-pphenylenediamine (84041-77-0)
Insufficient testing
SCCS/1463/12
B36 B37
SCCS/1229/09 SCCP/1035/06
B38
No value. Should have been tested at higher conc. No value. Should have been tested at higher conc.
SCCS/1230/09
B41
HC Yellow n 2 (4926-55-0)
Insufficient testing
GPMT Inadequate
SCCS/1309/10
SCCS/1509/13
COLIPA n
Sensitising potency category, based on results from LLNA or guinea pig assays
Guinea pig assay GPMT: i.d. induction conc (%)/incidence of sens (%) Buehler test: topical induction conc (%)/incidence of sens (%)
References
B47
HC Orange n 1 (54381-08-7)
Not classifiable
GPMT 0.1/0
SCCP/1164/08
B48 B50
Extreme Extreme
SCCP/0981/06 SCCS/1293/10
4-Amino-3-nitrophenol (610-81-1) 2-Hydroxyethylamino-5-nitroanisole (66095-81-6) 3-Nitro-p-hydroxyethylaminophenol (65235-31-6) 3-Methylamino-4-nitrophenoxy ethanol (59820-63-2) 2-Nitro-5-glyceryl-methylaniline (80062-31-3)
0.2 no value 0.07 no value No value. Should have been tested at higher conc. 0.9 1.10
B66 B67
Strong Strong
SCCP/1025/06 SCCP/1103/07
SCCS/1509/13
COLIPA n
Sensitising potency category, based on results from LLNA or guinea pig assays
Guinea pig assay GPMT: i.d. induction conc (%)/incidence of sens (%) Buehler test: topical induction conc (%)/incidence of sens (%)
References
B69
Insufficient testing
No value. Should have been tested at higher conc. No value. Should have been tested at higher conc. No value. Should have been tested at higher conc. No value. Should have been tested at higher conc. Results indicate sens. 5.0
SCCS/1301/10
B70
Insufficient testing
SCCS/1369/10
B71
Insufficient testing
SCCS/1406/11
B72
SCCP/1208/08
B73
Moderate
SCCP/1209/08
SCCS/1509/13
COLIPA n
Sensitising potency category, based on results from LLNA or guinea pig assays
Guinea pig assay GPMT: i.d. induction conc (%)/incidence of sens (%) Buehler test: topical induction conc (%)/incidence of sens (%)
References
B75
Hydroxyethyl-2-nitro-p-toluidine (100418-33-5)
Insufficient testing
No value. Should have been tested at higher conc. No value. Should have been tested at higher conc. No value. Should have been tested at higher conc. No value. Should have been tested at higher conc. No value. Should have been tested at higher conc.
SCCS/1387/10
B77
HC Blue n 11 (23920-15-2)
Insufficient testing
SCCP/1079/07
B80
HC Yellow n 7 (104226-21-3)
Insufficient testing
SCCS/1292/10
B81
HC Yellow n 10 (109023-83-8)
Insufficient testing
SCCP/1080/O7
B87
Insufficient testing
SCCS/1302/10
SCCS/1509/13
COLIPA n
Sensitising potency category, based on results from LLNA or guinea pig assays
Guinea pig assay GPMT: i.d. induction conc (%)/incidence of sens (%) Buehler test: topical induction conc (%)/incidence of sens (%)
References
2-Chloro-6-ethylamino-4nitrophenol (131657-78-8) HC Violet n 2 (104226-19-9) 2-Amino-6-chloro-4-nitrophenol (6358-09-4) 4-Hydroxypropylamino-3nitrophenol (92952-81-3) HC Yellow n 13 (10442-83-8) 2,6-Diamino-3-((pyridin-3yl)azo)pyridine (28365-08-4)
B113
GPMT Results indicative of sens. Additional conc. should have been used GPMT and Buehler Inconclusive ** GPMT 5/0 GPMT 1/0 GPMT 5/0 test not considered adequate
SCCP/1116/07
B115
Insufficient testing
SCCS/1340/11
3.12
SCCS/1509/13
COLIPA n
Sensitising potency category, based on results from LLNA or guinea pig assays
Guinea pig assay GPMT: i.d. induction conc (%)/incidence of sens (%) Buehler test: topical induction conc (%)/incidence of sens (%)
References
C8
Insufficient testing
No value. Should have been tested at higher conc. 12.2 No value. Should have been tested at higher conc. No value. Should have been tested at higher conc.
SCCS/1385/10
C9 C10
SCCP/1165/08 SCCS/1231/09
C15
Not classifiable
GPMT 25/0
SCCS/1382/10
no value
SCCS/1509/13
COLIPA n
Sensitising potency category, based on results from LLNA or guinea pig assays
Guinea pig assay GPMT: i.d. induction conc (%)/incidence of sens (%) Buehler test: topical induction conc (%)/incidence of sens (%)
References
C53
Insufficient testing
SCCS/1428/11
C54
Insufficient testing Not classifiable Moderate Not classifiable Insufficient testing Strong
Test by nonguideline method GPMT 0.1/0 Inadequate description GPMT 0.875/90 Buehler 8.65/47
SCCNFP/0789/04
Acid Violet 43 (4430-18-6) Disperse Violet 1 (128-95-0) Acid Blue 62 (4368-56-3) Disperse Black 9 (12222-69-4) (20721-50-0) Hydroxyanthroquinone aminopropyl methyl morpholinium methosulphate (38866-20-5)
C117
SCCP/0875/05
Lawsone (83-72-7) Lawsonia inermis (syn. Henna) (84988-66-9; 83-72-7) Indigofera tinctoria (84775-63-3)
SCCS/1509/13
COLIPA n
Sensitising potency category, based on results from LLNA or guinea pig assays
Guinea pig assay GPMT: i.d. induction conc (%)/incidence of sens (%) Buehler test: topical induction conc (%)/incidence of sens (%)
References
C172
HC Blue n 14 (99788-75-7)
Not classifiable
GPMT 2.5/0
SCCS/1383/10
Curry Red (25956-17-6) Acid Red 18 (2611-82-7) Acid Red 52 (3520-42-1) Acid Green 25 (4403-90-1) Disperse Blue 337 (67674-26-4 + 67701-36-4 + 4471-41-4)
Not classifiable Not classifiable Not classifiable Insufficient testing Insufficient testing
No value. Should have been tested at higher conc. No value. Should have been tested at higher conc.
C181
Insufficient testing
SCCS1411/11
SCCS/1509/13
COLIPA n
Sensitising potency category, based on results from LLNA or guinea pig assays
Guinea pig assay GPMT: i.d. induction conc (%)/incidence of sens (%) Buehler test: topical induction conc (%)/incidence of sens (%)
References
C182
HC Blue 15 (74578-10-2)
Insufficient testing
No value. Should have been tested at higher conc. No value. Should have been tested at higher conc.
SCCS/1440/11
C183
Insufficient testing
SCCS/1426/11
*The lowest test concentration was too high and EC3 value could not be calculated; or EC3 value was not calculated in the reference
** Staining of the skin might have interfered with reading of test reaction