Hair Dye Chemical Sensitization

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The document discusses the evaluation of sensitizing properties of hair dye substances that were assessed by the SCCP and SCCS. It provides sensitizing potency categories and test results for various hair dye substances.

The three independent non-food Scientific Committees, including SCCS, provide scientific advice to the European Commission when preparing policy and proposals relating to consumer safety, public health, and the environment. They also draw attention to new or emerging problems.

The Scientific Committees, including SCCS, evaluate health and safety risks, notably chemical, biological, mechanical and other physical risks of non-food consumer products and services.

SCCS/1509/13

Scientific Committee on Consumer Safety SCCS

Memorandum on hair dye Chemical Sensitisation

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]

European Union, 2013 ISSN 1831Doi:10.2773/

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

(associated scientific advisor) (chairman)

(rapporteur)

National Food Institute, Denmark

Keywords:

SCCS, memorandum, hair dyes, sensitisation, directive 76/768/ECC

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.

Extreme Strong Moderate Insufficient testing + Possibly sensitising Not classifiable

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

p-Phenylenediamine (106-50-3) 2-Chloro-p-phenylenediamine (61566-7)

Extreme Moderate ?

0.06 ? ?

SCCS/1443/11 4 Oct 1991

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

A11 A12 A15

Strong Moderate Strong

1.4 5.8 0.24

SCCS/1270/09 SCCS/1224/09 SCCP/0978/06

A16

Results indicate sens potential Strong

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

1,5-Naphthalenediol (83-56-7) 2,7-Naphthalenediol (582-17-2)

Moderate Moderate

3.4 2.8

SCCS/1365/10 SCCS/1366/10

SCCS/1509/13

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 (%)

References

A22 A25 A27 A31

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 -

SCCP/0963/05 SCCP/0965/05 SCCP/1001/06 SCCP/0957/05

0.44 no value

A33 A39 A42 A43

0.08 1 3.2 16.8

Buehler 100/10 -

SCCP/0962/05 SCCP/1033/06 SCCS/1367/10 SCCP/1205/08

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

4-Amino-m-cresol (2835-99-6) 6-Amino-m-cresol (2835-98-5)

Strong Strong

SCCP/0895/05 SCCS/1400/11

SCCS/1509/13

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 (%)

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

Strong Insufficient testing

0.57 No value. Should have been tested at higher conc. < 0.5 *

SCCS/1310/10 SCCS/1250/09

A98

Hydroxyethyl-3,4methylenedioxyaniline HCl (9415814-2) 2,6-Dihydroxy-3,4-dimethylpyridine (84540-47-6)

Strong

SCCS/1269/09

A99

Results indicate sens potential Strong

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

Extreme Insufficient testing

0.17 No value. Should have been tested at higher conc. -

GPMT 0.1/0 -

SCCP/0952/05 SCCP/1120/07

A121

Hydroxypropyl bis (Nhydroxyethyl-p-phenylenediamine) HCl (128729-30-6, free base; 128729-28-2, hydrochloride)

Strong

GPMT 1/90

SCCS/1244/09

SCCS/1509/13

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 (%)

References

A128

6-Hydroxyindole (2380-86-1)

Extreme

<0.2 *; 0.2 <1 *; 2.5

GPMT 0.5/40 Buehler 5/30

SCCP/0947/05

A129

Isatin (91-56-5)

Extreme

GPMT 0.1/100; Buehler 25/0 **

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

A132 A136 A138 A143

Not classifiable Strong Not classifiable Insufficient testing Moderate

no value 0.25 no value -

GPMT Inappropriate testing GPMT 10/55; Buehler 40/0

SCCP/1126/07 SCCS/1450/11 SCCS/1425/11 SCCP/1122/07

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.

See A156 GPMT 1/100 Buelhler: 40/0 SCCS/1449/11

SCCS/1509/13

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 (%)

References

A155

2,2'-Methylenebis 4-aminophenol (63969-46-0; 27311-52-0, HCl)

Not classifiable

GPMT inadequate. Too low conc. used Buehler 50/5

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)

Strong Not classifiable Moderate

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

Acid Yellow 1 (846-70-8)

Moderate

No value. Should have been tested at higher conc. -

GPMT 5/100

SCCP/1160/08

B5

Disperse Red 17 (3179-89-3)

Insufficient testing Extreme

GPMT Results equivocal ** GPMT 0.1/70

SCCP/1161/08

B7

Basic Brown 17 (68391-32-2, HCl))

No value. Should have been tested at higher conc.

SCCS/1448/11 SCCP/0683/03

SCCS/1509/13

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 (%)

References

B24 B28 B31

4-Nitro-o-phenylenediamine (99-569) Picramic acid ( 96-91-3) HC Red n 13 (94158-13-1)

Extreme Moderate Moderate

0.05 6.7 8.2

GPMT inadequate. Too low conc. used -

SCCP/0980/06 SCCS/1227/10 SCCS/1368/10

B34

N,N-bis(Hydroxyethyl)-2-nitro-pphenylenediamine (84041-77-0)

Insufficient testing

No value. Should have been tested at higher conc. 1.2 5; no value

SCCS/1463/12

B36 B37

HC Red n 7 (24905-87-1) HC Blue n 2 (33229-34-4)

Strong Results indicate sens potential Not classifiable

SCCS/1229/09 SCCP/1035/06

B38

HC Yellow n 4 (52551-67-4 / 59820-43-8)

No value. Should have been tested at higher conc. No value. Should have been tested at higher conc.

GPMT Inadequate Too low conc. used Buehler 75/0

SCCS/1230/09

B41

HC Yellow n 2 (4926-55-0)

Insufficient testing

GPMT Inadequate

SCCS/1309/10

SCCS/1509/13

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 (%)

References

B47

HC Orange n 1 (54381-08-7)

Not classifiable

No value. Should have been tested at higher conc. <2 * 2*

GPMT 0.1/0

SCCP/1164/08

B48 B50

HC Red n 1 (2784-89-6) HC Red n 3 (2871-01-4)

Extreme Extreme

GPMT 0.1/100 GPMT 0.1/100 Buehler 3/0

SCCP/0981/06 SCCS/1293/10

B51 B52 B54 B58 B60

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)

Extreme Not classifiable Extreme Not classifiable Insufficient testing

0.2 no value 0.07 no value No value. Should have been tested at higher conc. 0.9 1.10

SCCP/1207/08 SCCS/1243/09 SCCP/1036/06 SCCP/1089/07 SCCP/1162/08

B66 B67

HC Violet n 1 (82576-75-8) HC Orange n 2 ( 85765-48-6)

Strong Strong

GPMT 25/0 ** GPMT 1/40

SCCP/1025/06 SCCP/1103/07

SCCS/1509/13

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 (%)

References

B69

HC Yellow n 9 (86419-69-4; 141973-33-3)

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

4-Nitrophenyl aminoethylurea (27080-42-8)

Insufficient testing

SCCS/1369/10

B71

HC Red n 10 + HC Red n 11 (95576-89-9 + 95576-92-4)

Insufficient testing

SCCS/1406/11

B72

2-Hydroxyethyl picramic acid (99610-72-7)

Results indicate sens potential

SCCP/1208/08

B73

HC Blue n 12 (104516-93-0, free base; 132885-85-9)

Moderate

SCCP/1209/08

SCCS/1509/13

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 (%)

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

4-Amino-2-nitrodiphenylamine-2carboxylic acid (117907-43-4)

Insufficient testing

SCCS/1302/10

SCCS/1509/13

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 (%)

References

B89 B98 B99 B100 B102 B111

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)

Moderate Moderate Strong Not classifiable Not classifiable Not classifiable

2.79 5.9 0.68 No value -

GPMT 10/0 GPMT 0.001/11; Buehler 25/0

SCCP/1090/07 SCCP/1082/07 SCCP/0948/05 SCCP/1082/07 SCCS/1322/10 SCCS/1338/10

B113

Basic Orange 69 (226940-14-3)

Results indicate sens potential

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

Basic Violet 2 (3248-91-7)

Insufficient testing

SCCS/1340/11

B116 B117 B118

Basic Red 51 (77061-58-6) Basic Yellow 87 (68259-00-7) Basic Orange 31 (97404-02-9)

Not classifiable Not classifiable Moderate

3.12

SCCS/1436/11 SCCS/1333/10 SCCS/1447/11

SCCS/1509/13

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 (%)

References

C8

Basic Red 76 (68391-30-0)

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

Basic Brown 16 (26381-41-9) Basic Yellow 57 (68391-31-1)

Moderate Insufficient testing

SCCP/1165/08 SCCS/1231/09

C15

Acid Orange 7 (633-96-5)

Not classifiable

GPMT 25/0

SCCS/1382/10

C22 C29 C40

Acid Red 33 (3567-66-6) Acid Yellow 23 (1934-21-0) Acid Blue 9 (3844-45-9)

Not classifiable Not classifiable Not classifiable

no value

GPMT 10/0 GPMT 5/0 -

SCCP/1102/07 SCCNFP/0786/04 SCCNFP/0787/04

SCCS/1509/13

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 (%)

References

C53

Acid Red 92 (18472-87-2)

Insufficient testing

No value. Should have been tested at higher conc.

SCCS/1428/11

C54

Acid Yellow 3 (8004-92-0)

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

C63 C64 C67 C106

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)

no value 3.75 no value -

SCCP/0964/05 SCCS/1232/09 SCCP/0878/05 SCCS/1233/09

C117

SCCP/0875/05

C146 C169 C170

Lawsone (83-72-7) Lawsonia inermis (syn. Henna) (84988-66-9; 83-72-7) Indigofera tinctoria (84775-63-3)

Strong Not classifiable Extreme

GPMT 1/65 ** Buehler 50/0 ** GPMT 0.1/100, 0.25/80 Buehler 20/0 **

SCCNFP/0798/04 SCCP/0943/05 SCCS/1439/11

SCCS/1509/13

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 (%)

References

C172

HC Blue n 14 (99788-75-7)

Not classifiable

No value. Should have been tested at higher conc. no value no value

GPMT 2.5/0

SCCS/1383/10

C174 C175 C177 C178 C179

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

GPMT 5/0 GPMT 5/0 too low conc. ** Buehler 10/0 **

SCCNFP/0791/04 SCCNFP/0792/04 SCCP/1115/07 SCCP/0879/05 SCCS/1399/11

No value. Should have been tested at higher conc. No value. Should have been tested at higher conc.

C181

Pigment Red 57 (5858-81-1)

Insufficient testing

SCCS1411/11

SCCS/1509/13

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 (%)

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

Tetrabromophenol Blue (4430-25-5)

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

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