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Annex III Entry 8 17/06/2014

N-substituted derivatives of p- Phenylenediamine and their salts; N- substituted derivatives of o-Phenylenediamine (1 ), with exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II

Key data

CAS
EC
Annex
Entry number
8

Source and verification note

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Record details

Chemical name

N-substituted derivatives of p- Phenylenediamine and their salts; N- substituted derivatives of o-Phenylenediamine (1 ), with exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II

Maximum concentration

(a) General use (b) Professional use For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3 % calculated as free base

Other restrictions

(1 ) These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1.’

Warnings

(a) To be printed on the label: The mixing ratio. “ Hair colourants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past. Contains phenylenediamines. Do not use to dye eyelashes or eyebrows”
(b) To be printed on the label: The mixing ratio. “For professional use only Hair colourants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past. Contains phenylenediamines. Wear suitable gloves”

Regulatory information

Regulation

(EC) 2013/344

SCCS opinions

  • Updated Recommended Strategy for Testing Hair Dyes for Their Potential Genotoxicity/Mutagenicity/Carcinogenicity
  • Opinion concerning Use of Permanent Hair Dyes and Bladder Cancer - Updated 2004
  • Opinion on Personal Use of Hair Dyes and Cancer Risk
  • Opinion on the Use of Permanent Hair Dyes and Bladder Cancer Risk
  • Assessment Strategies for Hair Dyes
  • Opinion concerning p-Phenylenediamine
  • Opinion on p-Phenylenediamine
  • Foreseeable use of hair dyes
  • Memorandum on Hair Dye Substances and their Skin Sensitising Properties

Identified ingredients

  • N-PHENYL-P-PHENYLENEDIAMINE
  • N-PHENYL-P-PHENYLENEDIAMINE HCL
  • N-PHENYL-P-PHENYLENEDIAMINE SULFATE
  • N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE
Annex III 16
Shared product type

1-NAPHTHOL

CAS: 90-15-3
EC: 201-969-4
Annex III 16
Shared product type

1-Naphthol

CAS: 90-15-3
EC: 201-969-4
Annex III 193
Shared product type

ACID RED 52

CAS: 3520-42-1
EC: 222-529-8

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