HC BLUE NO. 12 (HC Blue 12)

What official classifications and rules say for each group. A classification describes the hazard of the pure substance, not the risk of a product that contains it, which depends on the dose and the exposure.

Prohibition or serious classificationThe text prohibits the substance for this use, or ranks it among the most serious hazards (known or presumed carcinogenic, mutagenic or reprotoxic, identified endocrine disruptor).Worth watchingThe text sets a condition or flags a hazard worth knowing: allergen, suspected effect, condition for children, hazard to the aquatic environment.For informationOfficial information with no condition on a finished product: warning to read, irritation of the pure substance.

• Pregnancy and breastfeeding

  No classification harmonised by the European Union covers reproduction, the unborn child or breastfeeding for this substance. This does not mean it has been judged to have no effect during pregnancy.

• Babies and children

  The Cosmetics Regulation sets no age-related condition for this ingredient.

• Skin, eyes and allergies

  Worth watchingThe text sets a condition or flags a hazard worth knowing: allergen, suspected effect, condition for children, hazard to the aquatic environment.

  Worth watching Classified under the CLPEU regulation that classifies chemicals by their hazards (EC No 1272/2008). Regulation: skin sensitisation, category 1 (Skin Sens. 1).

• Environment

  For informationOfficial information with no condition on a finished product: warning to read, irritation of the pure substance.

  For information Classified under the CLP Regulation: hazardous to the aquatic environment, long term, category 3 (Aquatic Chronic 3).

• Read on the label

  For informationOfficial information with no condition on a finished product: warning to read, irritation of the pure substance.

  For information Annex III, entry 225, requires a warning that depends on the type of product: Hair dye substance in oxidative hair dye products: “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: —…”. None for: Hair dye substance in non-oxidative hair dye products.

Allowed with restrictions

Entry

Annex III, No 225

Substance

1-(beta-Hydroxyethyl)amino-2-nitro-4-N-ethyl-N-(beta-hydroxyethyl)aminobenzene and its hydrocloride

Glossary names

HC BLUE NO. 12

CAS

104516-93-0 - 132885-85-9

EC

407-020-2

Identity

CosIng identifier

34189

CAS (according to CosIng)

104516-93-0, 132885-85-9

EC (according to CosIng)

407-020-2

Declared functions

Hair dyeing

Wikidata

Q72481076

ECHA InfoCard

100.100.856

CosIng cites 2 CAS numbers for this name: it covers several substances.

4-[N-ethyl-N-(2-hydroxyethyl)amino]-1-(2-hydroxyethyl)amino-2-nitrobenzene, monohydrochloride

Neither carcinogenic, mutagenic nor toxic for reproduction under the harmonised classification

Hazard classes

Acute toxicity, category 4 (Acute Tox. 4)
Skin sensitisation, category 1 (Skin Sens. 1)
Hazardous to the aquatic environment, long term, category 3 (Aquatic Chronic 3)

Hazard statements

H302 H317 H412

United Kingdom (Great Britain)

• Allowed with restrictions (Annex III)

Same entries as in the European Union. Their maximum concentrations are compared in the “Comparison between countries” table; other conditions (product types, warnings) may differ.

Switzerland

Regulation (EC) No 1223/2009 applies in Switzerland (Article 54 of the Ordinance on Foodstuffs and Utility Articles).

United States, federal rules

None of the integrated sections of the federal code (21 CFR 700.11 to 700.27 and 250.250) targets this name. The FDA does not publish a list of allowed ingredients.

South Korea

• Allowed colorant: 에치씨청색 12 호 (HC Blue No. 12) (HC Blue No. 12)

  색소 고시 별표 1 (allowed colorants), entry 125, page 7. Limit: 1.5%.

  Conditions, source text, in Korean

  염모용 화장품에만 사용 | ◎ 사용한도 1.5% | 비고: 타르색소

• Prohibited: 1-(베타-하이드록시)아미노-2-니트로-4-N-에칠-N-(베타-하이드록시에칠)아미노벤젠 및 그 염류(예 : 에이치시 청색 No. 13)

  별표 1 (prohibited substances), entry 342, page 18.

  Conditions, source text, in Korean

  화학물질명: 1-(베타-하이드록시)아미노-2-니트로-4-N-에칠-N-(베타-하이드록시에칠)아미노벤젠 (CAS No. 104516-93-0) | 화학물질명: 1-(베타-하이드록시)아미노-2-니트로-4-N-에칠-N-(베타-하이드록시에칠)아미노벤젠 하이드로클로라이드 (CAS No. 132885-85-9)

ASEAN (South-East Asia)

• Restricted (conditions or maximum concentration): 1-(beta-Hydroxyethyl)amino-2-nitro-4-N-ethyl-N-(.beta.-hydroxyethyl)aminobenzene and its hydrochloride' HC Blue No 12

  Annex III (restricted substances), entry 225, page 164. Limit: (b) 1.5% (as hydrochloride).

  Conditions, source text

  Field of application and/or use: (a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products Use for dyeing eyelashes and eyebrows is not permitted. | Other limitations and requirements: (a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0.75 % (as hydrochloride) For (a) and (b): • Do not use with nitrosating agents • Maximum nitrosamine content: 50 μg/kg(21) • 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: (a) 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 (a) and (b) Do not use to dye eyelashes or eyebrows

Taiwan

• Restricted (conditions or maximum concentration): 1-(beta-Hydroxyethyl)amino-2-nitro-4-N-ethyl-N-(beta-hydroxyethyl)aminobenzene and its hydrochloride (HC Blue No. 12)

  化粧品成分使用限制表 (restricted substances). Limit: (a)0.75% (以hydrochloride計) (b)1.5% (以hydrochloride計).

  Conditions, source text, in Chinese

  產品類型／使用範圍：(a)氧化性染髮產品 (b)非氧化性染髮產品 | 限制規定：不得與亞硝基化劑一起使用; 亞硝胺限量:50 microgram/kg (ppb); 應置於無亞硝基酸鹽之容器

6 recorded products list it, according to Open Beauty Facts contributors. Records are dated: the formula may have changed. See the list (in French).