Definition
US FDA substance register · UNII 8IRK9YBY3K · registered name HYDROXYETHYL-3,4-METHYLENEDIOXYANILINE HYDROCHLORIDE · single chemical substance
Cosmetic roles
Safety & regulatory references
- Banned
- South Korea
- Restricted or banned
- South Korea · Taiwan
- Restricted
- Taiwan · United Kingdom
Source: MFDS (Korea) cosmetic regulatory information · ASEAN Cosmetic Directive · EU Cosmetics Regulation · Taiwan FDA cosmetic ingredients · Taiwan FDA cosmetic regulations · UK cosmetics regulations (OPSS)
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 1.5 % • Do not use with nitrosating systems • Maximum nitrosamine content: 50 μg/kg • Keep in nitrite-free containers 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 : The mixing ratio must be printed on the label. Hair colorants 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 Do not use to dye eyelashes or eyebrows
China
- Maximum concentration : 1.5%
European Union
- Product Type, body parts : Hair dye substance in oxidative hair dye products
- Other : After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1.5% - Do not use with nitrosating agents - Maximum nitrosamine content: 50 microgram/Kg - Keep in nitrite-free containers
- Wording of conditions of use and warnings : Hair colourants can use severe allergic reactions Read and folow instructions
Source: MFDS (Korea) cosmetic regulatory information
EU Cosmetics Regulation, Annex III (restricted substances), entry 246 · applies to Hair dye substance in oxidative hair dye products
Restriction III/246 · Other restriction: ban substances that deplete the ozone layer
Source: EU CosIng ingredient list
Reviewed by CIR: Safety Assessment of Hydroxyethyl-3,4-Methylenedioxyaniline HCl as Used in Cosmetics
More data — names, identifiers, properties, test records, literature
Names & identifiers
- CAS No.chemical registry number
- 94158-14-2
- EC No.EU chemical inventory number
- 303-085-5
- DTXSIDUS EPA chemical ID
- DTXSID20240825
- DTXCIDUS EPA compound ID
- DTXCID50163316
- IUPAC
- 2-[(2H-1,3-Benzodioxol-5-yl)amino]ethan-1-ol--hydrogen chloride (1/1)
- Molecular formula
- C9H12ClNO3
- Molecular weight
- 217.65 g/mol
What products actually use it for
What the 3 products reported to the US EPA with this ingredient use it for. Products outside cosmetics are included, so the top few rows are its main uses.
- Dye3
Source: US EPA CompTox dashboard
Irritation and sensitisation studies
1 skin studies and 0 eye studies are on record.
The study conclusions largely agree (100%). These tests are on the raw material itself; irritation at the amount in a finished product is a different question.
See all 1 studies
- High Frequency of Sensitization
skin sensitisation: in vivo (LLNA) · Screening · according to OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Source: US EPA CompTox dashboard
Related literature
Linked databases 21
- ASEAN Cosmetic Directive
- Australian Industrial Chemicals Inventory (AICIS)
- China inventory of existing ingredients (IECIC)
- EU CosIng ingredient list 2
- EU Cosmetics Regulation
- EU restricted substances (Annex III)
- EU SCCS safety opinions 2
- Korea Cosmetic Association ingredient dictionary
- MFDS (Korea) cosmetic ingredient register 2
- MFDS (Korea) cosmetic regulatory information 2 3 4
- Taiwan FDA cosmetic ingredients
- Taiwan FDA cosmetic regulations
- Tlooto literature search
- UK cosmetics regulations (OPSS)
- UniChem cross-reference IDs
- US Cosmetic Ingredient Review (CIR) 2
- US EPA CompTox dashboard 2
- US EPA DSSTox chemical database
- US FDA substance registration (GSRS)
- US FDA Unique Ingredient Identifier (UNII)
- Wikidata