BISHYDROXYETHYL BISCETYL MALONAMIDE

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

  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: reproductive toxicity, category 2 (Repr. 2), a hazard to fertility.

  For a question about your own situation, ask your doctor, midwife or pharmacist.

• Babies and children

  Prohibited in cosmetics in the European Union for everyone, whatever the age or situation: no specific condition is therefore needed for this group.

• Skin, eyes and allergies

  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: eye irritation, category 2 (Eye Irrit. 2). This classification describes the pure substance; in a finished product it is far more diluted.

• 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 4 (Aquatic Chronic 4).

• Read on the label

  The Cosmetics Regulation requires no warning to be printed for this ingredient.

Prohibited in cosmetics

CosIng links the name BISHYDROXYETHYL BISCETYL MALONAMIDE to this Annex II entry.

Entry

Annex II, No 1243

Substance

N,N'-Dihexadecyl-N,N'-bis(2-hydroxyethyl)propanediamide; Bishydroxyethyl Biscetyl Malonamide

CAS

149591-38-8

EC

422-560-9

Identity

CosIng identifier

32192

CAS (according to CosIng)

149591-38-8

EC (according to CosIng)

422-560-9

Declared functions

Hair conditioning, Skin conditioning, Skin protecting

N,N'-dihexadecyl-N,N'-bis(2-hydroxyethyl)propanediamide

Reproductive toxicity, category 2 (Repr. 2)

Hazard classes

Reproductive toxicity, category 2 (Repr. 2)
Eye irritation, category 2 (Eye Irrit. 2)
Hazardous to the aquatic environment, long term, category 4 (Aquatic Chronic 4)

Hazard statements

H361f *** H319 H413

• 7 May 2010: Hair colouring cream, Lakmé., Portugal (“Serious risk”) alert
  The products pose a chemical risk because they contain bishydroxyethyl biscetyl malonamide, which is banned under the Cosmetics Directive 76/768/EEC.
• 7 May 2010: Hair treatment products, Lakmé., Portugal (“Serious risk”) alert
  The products pose a chemical risk because they contain bishydroxyethyl biscetyl malonamide, which is banned under the Cosmetics Directive 76/768/EEC.
• 21 November 2008: Hair balsam - Bálsamo Nutritivo e Reparador, Botica Natural, Portugal (“Serious risk”) alert
  The product poses a chemical risk because it contains bishydroxyethyl biscetyl malonamide, which may be carcinogenic, mutagenic or toxic for reproduction and which is banned under the Cosmetic Directive 76/768/EEC.

United Kingdom (Great Britain)

• Prohibited in cosmetics (Annex II)

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

• Prohibited: N,N'-디헥사데실-N,N'-비스(2-하이드록시에칠)프로판디아마이드 ; 비스하이드록시에칠비스세틸말론아마이드

  별표 1 (prohibited substances), entry 215, page 11.

China

• Prohibited: 双羟乙基双鲸蜡基马来酰胺 (N,N’-dihexadecyl-N,N’-bis（2-hydroxyethyl）propanediamide, Bishydroxyethyl Biscetyl Malonamide （CAS No. 149591-38-8）)

  表1 化妆品禁用原料目录 (prohibited substances, 2021年第74号), entry 933, page 附件2 (.doc) table row 933 ; TID reprint p.36.

ASEAN (South-East Asia)

• Prohibited: N,N'-Dihexadecyl-N,N'-bis(2-hydroxyethyl)propanediamide; Bishydroxyethyl Biscetyl Malonamide

  Annex II (prohibited substances), entry 1243, page 55.

Brazil

• Prohibited: N,N¢-dihexadecil-N,N¢-bis(2-hidroxietil)propanodiamida bishidroxietil biscetil malonamida

  RDC 529/2021, Anexo (prohibited substances), entry 1243, page 42.

  Conditions, source text, in Portuguese

  N° UE: 1243