P-PHENYLENEDIAMINE

1,4-phenylenediamine is a phenylenediamine in which the amino functions are at positions 1 and 4 of the benzene nucleus. It has a role as a reagent, a dye, an allergen and a hapten.

Source: PubChem

US FDA substance register · UNII U770QIT64J · registered name P-Phenylenediamine · single chemical substance

Source: US FDA Unique Ingredient Identifier (UNII)

(CI 76060)

Banned

Taiwan

Restricted or banned

South Korea · Taiwan

Restricted

Taiwan · United Kingdom

Source: Taiwan FDA cosmetic ingredients · MFDS (Korea) cosmetic regulatory information · ASEAN Cosmetic Directive · EU Cosmetics Regulation · Health Canada Cosmetic Ingredient Hotlist · Taiwan FDA cosmetic regulations · UK cosmetics regulations (OPSS)

Argentina · Brazil

• Field of application and/or use : Oxidation dyes for coloring hairs 1. General Use 2. Professional Use
• Maximum concentration permitted at final product : 6% calculated as free base
• Use conditions and warnings that must appear on the label : 1) - Can cause allergic reaction - "Contains phenylenediamine" Contains phenylenediamines. Do not use on eyebrows or eyelashes. 2) Can cause allergic reaction Contains phenylenediamines. For professional use only. Wear suitable gloves

ASEAN

• Field of application and/or use : Hair dye substance in oxidative hair dye products Use for dyeing eyelashes and eyebrows is not permitted.
• Other limitations and requirements : After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2 % calculated as free base The direction for use “wear suitable gloves” must be included in label or leaflet text.
• Conditions of use and warning which must be printed on the labels : 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.”

Canada

• Conditions of Use by product type : (a) Not permitted in products intended for use on the skin. (b) Oxidative hair dyes
• Maximum Concentration Permitted : (b) 3% after dilution with an oxidizer
• Warnings and Cautionary Statements: (to the effect of) : (b) On the inner label and the outer label of the cosmetic: "CAUTION: This product contains ingredients that may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dying the eyelashes or eyebrows. To do so may cause blindness." Instructions to the following effect accompany each package of hair dye: 1. the preparation may cause serious inflammation of the skin in some persons and a preliminary test should always be carried out to determine whether or not special sensitivity exists; and 2. to make the test, a small area of skin behind the ear or on the inner surface of the forearm should be cleansed, using either soap and water or alcohol, and a small quantity of the hair dye as prepared for use should be applied to the area and allowed to dry. After 24 hours, the area should be washed gently with soap and water. If no irritation or inflammation is apparent, it is usually assumed that no hypersensitivity to the dye exists. The test should, however, be carried out before each application. On no account should the hair dye be used for dyeing eyebrows or eyelashes as severe inflammation of the eye or even blindness may result.

China

• Maximum concentration : 2%

European Union

• Restrictions Product Type, body parts : Hair dye substance in oxidative hair dye products
• Restrictions Other : (a) General use (b) Professional use For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2 % calculated as free base
• Wording of conditions of use and 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.’
• Restrictions Product Type, body parts : Products intended for colouring eyelashes
• Restrictions Other : After mixing under oxidative conditions the maximum concentration applied to eyelashes must not exceed 2 % calculated as free base. For professional use only.
• Wording of conditions of use and warnings : To be printed on the label: The mixing ratio. “For professional use only. This product 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 the risk of allergy. Eyelashes shall not be coloured if the consumer: — has a rash on the face or sensitive, irritated and damaged scalp, — has experienced any reaction after colouring hair or eyelashes, — has experienced a reaction to a temporary ‘black henna’ tattoo in the past. Rinse eyes immediately if product comes into contact with them. Contains phenylenediamines. Wear suitable gloves.” ’

Korea’s toxic-substance GHS classification: Danger · H301 (category 3) · H410 (category 1) · H331 (category 3) · +4 more

Source: Korea toxic substances GHS register (NIER)

Restriction III/8a

Source: EU CosIng ingredient list

Reviewed by CIR: Annual Review of Cosmetic Ingredient Safety Assessments - 2004/2005

Source: US Cosmetic Ingredient Review (CIR)

Reviewed by CIR: Final Report: Amended Safety Assessment of p-Phenylenediamine, p-Phenylenediamine HCl and p-Phenylenediamine Sulfate as Used in Cosmetics

Source: US Cosmetic Ingredient Review (CIR)

Reviewed by CIR: Final Amended Report on the Safety Assessment of p-Phenylenediamine, p-Phenylenediamine HCl and p-Phenlyenediamine Sulfate

Source: US Cosmetic Ingredient Review (CIR)

Reviewed by CIR: Final Report on the Safety Assessment of p-Phenylenediamine

Source: US Cosmetic Ingredient Review (CIR)