Annex II
Entry 410
07/01/2011
Nitrosamines e.g. Dimethylnitrosoamine; Nitrosodipropylamine; 2,2'-(Nitrosoimino)bisethanol
Nitrosamines e.g. Dimethylnitrosoamine; Nitrosodipropylamine; 2,2'-(Nitrosoimino)bisethanol is listed in Annex II as a prohibited substance for cosmetic products placed on the EU market.
Prohibited substance— Annex II, EU Regulation 1223/2009
Entry: 410
Chemical identity and properties
CAS 1116-54-7PubChem CID 14223
N-Nitrosodiethanolamine
N-Nitrosodiethanolamine is a nitroso compound. — ChEBI
- IUPAC name
- N,N-bis(2-hydroxyethyl)nitrous amide
- Molecular formula
- C4H10N2O3
- Molecular weight
- 134.13 g/mol
- Exact mass
- 134.06914219 Da
- XLogP3
- -1.5
- Topological polar surface area
- 73.1 Ų
- Hydrogen-bond donors
- 2
- Hydrogen-bond acceptors
- 5
- Covalent units
- 1
- Defined stereocentres
- 0
Also known as
NdelaDiethanolnitrosamineNitrosodiethanolamine2,2'-(Nitrosoimino)bisethanolDiethanolnitrosoamineN,N-DiethanolnitrosamineNitrosoimino diethanolN-Nitrosoaminodiethanol
16 more reported names
NCI-C55583DiaethanolnitrosaminEthanol, N-nitrosoiminodi-N-NitrosodiaethanolaminEthanol, 2,2'-(nitrosoimino)bis-2,2'-Iminodi-N-nitrosoethanolEthanol, 2,2'-nitrosiminodi-N-Nitrosobis(2-hydroxyethyl)amineBis(beta-hydroxyethyl)nitrosamineDiethylamine, 2,2'-dihydroxy-N-nitroso-2,2'-nitrosiminodiethanolBis(beta-hydroxyaethyl)nitrosamin30YI1289VYDI-(2-HYDROXYETHYL)NITROSAMINEN-nitrosoiminodiethanolRefChem:830844
External database identifiers
- ChEBI:CHEBI:82357
- ChEMBL:CHEMBL1334
- EPA DTXSID:DTXSID7021027
- PubMed:37527026
- PubMed:30102407
- PubMed:18616954
Evidence from additional scientific databases
NIH PubChem PUG-View
Exact identifier match14223
Attributed physical-property, hazard, environmental and use annotations.
- Boiling Point: 237 °F at 1.5 mmHg (NTP, 1992) Source: CAMEO Chemicals
- Boiling Point: 114 °C at 1.4 mm Hg Source: Hazardous Substances Data Bank (HSDB)
- Boiling Point: 237 °F at 1.5 mmHg Source: Occupational Safety and Health Administration (OSHA)
- Color/Form: Light yellow oil Source: Hazardous Substances Data Bank (HSDB)
- Color/Form: Viscous yellow oil Source: Hazardous Substances Data Bank (HSDB)
- Density: 1.28 (NTP, 1992) - Denser than water; will sink Source: CAMEO Chemicals
- Density: 1.28 Source: Occupational Safety and Health Administration (OSHA)
- Odor: Odorless Source: Hazardous Substances Data Bank (HSDB)
- Physical Description: N-nitrosodiethanolamine is a yellow to dark brown very viscous liquid with no distinct odor. (NTP, 1992) Source: CAMEO Chemicals
- Physical Description: Light yellow liquid; [Merck Index] Source: Haz-Map, Information on Hazardous Chemicals and Occupational Diseases
- Physical Description: Yellow to dark brown very viscous liquid with no distinct odor. Source: Occupational Safety and Health Administration (OSHA)
- Refractive Index: Max absorption (water): 234 nm (E= 470.7); 345 nm (Log E= 5.3); index of refraction: 1.4540 @ 20 °C/D Source: Hazardous Substances Data Bank (HSDB)
- Refractive Index: Index of refraction: 1.4849 at 20 °C/D Source: Hazardous Substances Data Bank (HSDB)
- Solubility: greater than or equal to 100 mg/mL at 68.9 °F (NTP, 1992) Source: CAMEO Chemicals
- Solubility: Miscible with water in all proportions; soluble in polar organic solvents; insoluble in non-polar organic solvents Source: Hazardous Substances Data Bank (HSDB)
- Vapor Pressure: 0.0005 [mmHg] Source: Haz-Map, Information on Hazardous Chemicals and Occupational Diseases
- Viscosity: Highly viscous Source: Hazardous Substances Data Bank (HSDB)
- IARC Carcinogenic Agent: N-Nitrosodiethanolamine Source: International Agency for Research on Cancer (IARC)
- IARC Carcinogenic Classes: Group 2B: Possibly carcinogenic to humans Source: International Agency for Research on Cancer (IARC)
- IARC Monographs: Volume 17: (1978) Some N-Nitroso Compounds; Volume Sup 7: Overall Evaluations of Carcinogenicity: An Updating of IARC Monographs Volumes 1 to 42, 1987; 440 pages; ISBN 92-832-1411-0 (out of print); Volume 77: (2000) Some Industrial Chemicals Source: International Agency for Research on Cancer (IARC)
- Publication Year: 2000 Source: International Agency for Research on Cancer (IARC)
- Evaluation Year: 2000 Source: International Agency for Research on Cancer (IARC)
- First Aid: EYES: First check the victim for contact lenses and remove if present. Flush victim's eyes with water or normal saline solution for 20 to 30 minutes while simultaneously calling a hospital or poison control center. Do not put any ointments, oils, or medication in the victim's eyes without specific instructions from a physician. IMMEDIATELY transport the victim after flushing eyes to a hospital even if no symptoms (such as redness or irritation) develop.; SKIN: IMMEDIATELY flood affected skin with water while removing and isolating all contaminated clothing. Gently wash all affected skin areas thoroughly with soap and water. IMMEDIATELY call a hospital or poison control center even if no symptoms (such as redness or irritation) develop. IMMEDIATELY transport the victim to a hospital for treatment after washing the affected areas.; INHALATION: IMMEDIATELY leave the contaminated area; take deep breaths of fresh air. IMMEDIATELY call a physician and be prepared to transport the victim to a hospital even if no symptoms (such as wheezing, coughing, shortness of breath, or burning in the mouth, throat, or chest) develop. Provide proper respiratory protection to rescuers entering an unknow Source: CAMEO Chemicals
- Signal: Danger Source: Regulation (EC) No 1272/2008 of the European Parliament and of the Council
- GHS Hazard Statements: H350: May cause cancer [Danger Carcinogenicity] Source: Regulation (EC) No 1272/2008 of the European Parliament and of the Council
- Precautionary Statement Codes: P203, P280, P318, P405, and P501 (click each P-code to see the statement) Source: Regulation (EC) No 1272/2008 of the European Parliament and of the Council
- Signal: Danger Source: European Chemicals Agency (ECHA)
- GHS Hazard Statements: H225 (30.1%): Highly Flammable liquid and vapor [Danger Flammable liquids]; H350 (100%): May cause cancer [Danger Carcinogenicity] Source: European Chemicals Agency (ECHA)
- Precautionary Statement Codes: P203, P210, P233, P240, P241, P242, P243, P280, P303+P361+P353, P318, P370+P378, P403+P235, P405, and P501 (click each P-code to see the statement) Source: European Chemicals Agency (ECHA)
- ECHA C&L Notifications Summary: Aggregated GHS information provided per 133 reports by companies from 3 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.; Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown. For more detailed information, please visit ECHA C&L website. Source: European Chemicals Agency (ECHA)
- Signal: Danger Source: NITE-CMC
- GHS Hazard Statements: H350: May cause cancer [Danger Carcinogenicity] Source: NITE-CMC
- Precautionary Statement Codes: P203, P280, P318, P405, and P501 (click each P-code to see the statement) Source: NITE-CMC
- GHS Hazard Statements: H225: Highly Flammable liquid and vapor [Danger Flammable liquids] Source: NITE-CMC
- Precautionary Statement Codes: P210, P233, P240, P241, P242, P243, P280, P303+P361+P353, P370+P378, P403+P235, and P501 (click each P-code to see the statement) Source: NITE-CMC
- Environmental Bioconcentration: An estimated BCF of 3 was calculated in fish for N-nitrosodiethanolamine(SRC), using an estimated log Kow of -1.28(1) and a regression-derived equation(1). According to a classification scheme(2), this BCF suggests the potential for bioconcentration in aquatic organisms is low(SRC). Source: Hazardous Substances Data Bank (HSDB)
- Environmental Fate: TERRESTRIAL FATE: Based on a classification scheme(1), an estimated Koc value of 1(SRC), determined from a structure estimation method(2), indicates that N-nitrosodiethanolamine is expected to have very high mobility in soil(SRC). Volatilization of N-nitrosodiethanolamine from moist soil surfaces is not expected to be an important fate process(SRC) given an estimated Henry's Law constant of 4.9X10-12 atm-cu m/mole(SRC), using a fragment constant estimation method(2). N-Nitrosodiethanolamine is not expected to volatilize from dry soil surfaces based on an estimated vapor pressure of 5.0X10-4 mm Hg at 20 °C(3). N-Nitrosodiethanolamine has a UV absorption max at 345 nm(4) which indicates that the compound may be susceptible to direct photolysis by sunlight(SRC). Biodegradation in soil may be slow(SRC), based upon N-nitrosodiethanolamine's slow biodegradation in two lake waters and sewage(5). Source: Hazardous Substances Data Bank (HSDB)
- Environmental Fate: AQUATIC FATE: Based on a classification scheme(1), an estimated Koc value of 1(SRC), determined from a structure estimation method(2), indicates that N-nitrosodiethanolamine is not expected to adsorb to suspended solids and sediment(SRC). Volatilization from water surfaces is not expected(3) based upon an estimated Henry's Law constant of 4.9X10-12 atm-cu m/mole(SRC), developed using a fragment constant estimation method(2). According to a classification scheme(4), an estimated BCF of 3(SRC), from an estimated log Kow of -1.28(2) and a regression-derived equation(2), suggests the potential for bioconcentration in aquatic organisms is low. The direct photolysis rate constant for the analogous compound N-nitrosodiethylamine in aqueous solution exposed to irradiation representing Southern California midsummer, midday sun was observed to be 0.045/min with a half-life of 15 minutes and a quantum yield of 0.43(5); the photolysis rate of N-Nitrosodiethanolamine is expected to be similar(SRC). N-Nitrosodiethanolamine biodegraded slowly in samples of sewage and two lake waters(6). The fastest degradation of N-nitrosodiethanolamine in a lake water sample was in one taken in August; an initia Source: Hazardous Substances Data Bank (HSDB)
- Environmental Fate: ATMOSPHERIC FATE: According to a model of gas/particle partitioning of semivolatile organic compounds in the atmosphere(1), N-nitrosodiethanolamine, which has an estimated vapor pressure of 5.0X10-4 mm Hg at 20 °C(2), is expected to exist solely as a vapor in the ambient atmosphere. Vapor-phase N-nitrosodiethanolamine is degraded in the atmosphere by reaction with photochemically-produced hydroxyl radicals(SRC); the half-life for this reaction in air is estimated to be 13 hours(SRC), calculated from its rate constant of 3X10-11 cu cm/molecule-sec at 25 °C(SRC) that was derived using a structure estimation method(3). N-Nitrosodiethanolamine has a UV absorption max at 345 nm(4) which indicates that N-Nitrosodiethanolamine may be susceptible to direct photolysis by sunlight(SRC). Source: Hazardous Substances Data Bank (HSDB)
- Sources/Uses: May contaminate cosmetics and cutting fluids; [Merck Index] Used as a research chemical; [HSDB] Source: Haz-Map, Information on Hazardous Chemicals and Occupational Diseases
- Industrial Processes with risk of exposure: Metal Machining [Category: Heat or Machine] Source: Haz-Map, Information on Hazardous Chemicals and Occupational Diseases
- Uses: There is no known commercial use for N-nitrosodiethanolamine. Source: Hazardous Substances Data Bank (HSDB)
- Uses: It is available in research quantities. Source: Hazardous Substances Data Bank (HSDB)
Mapped by: Existing checksum-valid CAS to unique PubChem CID match. Retrieved: 2026-08-31. Open source record
Scientific classifications and hazard annotations provide context and do not replace the market-specific regulatory decision shown above.
Additional source coverage and match status
| Source | Result | Checked |
|---|---|---|
| NIH PubChem PUG-View | Exact match | 2026-08-31 |
A recorded no-match is useful evidence that the source was checked; it is not a claim that the substance does not exist elsewhere.
Retrieved from NIH PubChem on 2026-09-02 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.
CAS 62-75-9PubChem CID 6124
N-Nitrosodimethylamine
N-nitrosodimethylamine is a nitrosamine. It has a role as a geroprotector and a mutagen. — ChEBI
- IUPAC name
- N,N-dimethylnitrous amide
- Molecular formula
- C2H6N2O
- Molecular weight
- 74.08 g/mol
- Exact mass
- 74.048012819 Da
- XLogP3
- -0.6
- Topological polar surface area
- 32.7 Ų
- Hydrogen-bond donors
- 0
- Hydrogen-bond acceptors
- 3
- Covalent units
- 1
- Defined stereocentres
- 0
Also known as
DimethylnitrosamineNDMAN-Methyl-N-nitrosomethanamineDimethylnitrosoamineNitrosodimethylamineN,N-DimethylnitrosamineDMNAMethanamine, N-methyl-N-nitroso-
16 more reported names
Dimethylnitrosamindimethyl(nitroso)amineN-Nitroso-N,N-dimethylamineDimethylamine, N-nitroso-N-NitroaodimethylamineN-Dimethyl-nitrosaminenitrous dimethylamideRCRA waste number P082N-methyl-N-nitroso-methanamineN NitrosodimethylamineNDMA NitrosodimethylamineNitrosodimethylamine, NDMA1,1-Dimethyl-2-oxohydrazineM43H21IO8RNSC-23226CHEBI:35807
External database identifiers
- ChEBI:CHEBI:35807
- ChEMBL:CHEMBL117311
- EPA DTXSID:DTXSID7021029
- PubMed:39395750
- PubMed:35882637
- PubMed:34510228
- PubMed:34472159
- PubMed:32833043
- PubMed:30203046
- PubMed:30172374
- PubMed:29777724
- PubMed:29024620
- PubMed:28321044
- PubMed:27913846
- PubMed:27009110
Retrieved from NIH PubChem on 2026-08-31 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.
CAS 621-64-7PubChem CID 12130
N-Nitrosodipropylamine
N-Nitrosodi-n-propylamine is a nitroso compound. — ChEBI
- IUPAC name
- N,N-dipropylnitrous amide
- Molecular formula
- C6H14N2O
- Molecular weight
- 130.19 g/mol
- Exact mass
- 130.110613074 Da
- XLogP3
- 1.4
- Topological polar surface area
- 32.7 Ų
- Hydrogen-bond donors
- 0
- Hydrogen-bond acceptors
- 3
- Covalent units
- 1
- Defined stereocentres
- 0
Also known as
N-NITROSODI-N-PROPYLAMINEDipropylnitrosamineN,N-DipropylnitrosamineNitrosodipropylamineDi-n-propylnitrosamine1-Propanamine, N-nitroso-N-propyl-N-Nitroso-N-propyl-1-propanamineDipropylamine, N-nitroso-
16 more reported names
NDPADi-n-propylnitrosoaminePropylamine, N-nitroso-N-di-DPNAPropanamine, N-nitroso-N-propyl-N-Nitroso(di-n-propyl)amineN,N-Di-n-propylnitrosamineN-Nitroso-N-di-n-propylamineNSC-1332920IH58NCNSC133nitrous dipropylamideN-nitroso-N-dipropylamineRefChem:163988210-698-0RCRA waste number U111
External database identifiers
- ChEBI:CHEBI:82358
- ChEMBL:CHEMBL166242
- EPA DTXSID:DTXSID6021032
- PubMed:22967534
- PubMed:22490195
- PubMed:22368400
- PubMed:22352424
- PubMed:21863807
- PubMed:21860508
- PubMed:21819861
- PubMed:21377686
- PubMed:21089930
- PubMed:20816717
- PubMed:19161662
- PubMed:17937298
Retrieved from NIH PubChem on 2026-08-31 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.
Record details
Chemical name
Nitrosamines e.g. Dimethylnitrosoamine; Nitrosodipropylamine; 2,2'-(Nitrosoimino)bisethanol
Chemical / IUPAC name
N-Nitrosodiethanolamine (NDELA)
Regulatory information
Key data
Related records for Nitrosamines e.g. Dimethylnitrosoamine; Nitrosodipropylamine; 2,2'-(Nitrosoimino)bisethanol
Direct matches are limited for this record, so nearby entries from Annex II are shown as well.
Annex II
411
Nearby record in the same annex
Secondary alkyl- and alkanolamines and their salts
CAS: 111-42-2 / 110-97-4
EC: 203-868-0 / 203-820-9
Annex II
413
Nearby record in the same annex
2-Methyl-m-phenylenediamine (Toluene-2,6-diamine)
CAS: 823-40-5
EC: 212-513-9
Annex II
406
Nearby record in the same annex
4-Ethoxy-m-phenylenediamine and its salts
CAS: 67801-06-3 / 5862-77-1 / 68015-98-5 / 6219-69-8
EC: 267-125-2 / - / 268-164-8 / -
Annex II
414
Nearby record in the same annex
4-tert.-Butyl-3-methoxy-2,6-dinitrotoluene (Musk ambrette)
CAS: 83-66-9
EC: 201-493-7
What Annex II means for Nitrosamines e.g. Dimethylnitrosoamine; Nitrosodipropylamine; 2,2'-(Nitrosoimino)bisethanol
Nitrosamines e.g. Dimethylnitrosoamine; Nitrosodipropylamine; 2,2'-(Nitrosoimino)bisethanol is listed as a prohibited substance under Annex II of EU Cosmetics Regulation 1223/2009 and must not be intentionally added. Article 17 separately addresses unintended small quantities that are technically unavoidable under good manufacturing practice and compatible with the Article 3 safety requirement.
Formulators must screen their ingredients and raw materials to ensure none contain this substance. Suppliers should provide documentation confirming absence when requested.
The page also surfaces 12 related annex records with overlapping identifiers, annex logic or naming patterns.
Compliance checklist
- Verify this substance is absent from all raw materials and finished formulations.
- Request absence confirmation or CoA from raw material suppliers.
- Document the screening result in the Product Information File (PIF).
Frequently asked questions
Yes. Nitrosamines e.g. Dimethylnitrosoamine; Nitrosodipropylamine; 2,2'-(Nitrosoimino)bisethanol is listed in Annex II of EU Cosmetics Regulation 1223/2009 and is prohibited as an intentionally added cosmetic ingredient. Article 17 provides a narrow exception for unintended small quantities that are technically unavoidable under good manufacturing practice, provided the product remains safe under Article 3.
CAS 62-75-9 / 621-64-7 / 1116-54-7 is the unique numerical identifier assigned to Nitrosamines e.g. Dimethylnitrosoamine; Nitrosodipropylamine; 2,2'-(Nitrosoimino)bisethanol by the Chemical Abstracts Service. In cosmetic compliance work, the CAS number is used to cross-reference the substance across regulatory databases, raw material specifications and safety assessment reports. Multiple EU annex entries may share the same CAS number if the same substance appears under different conditions or in different annexes.
Use the INCI Checker tool on this site to paste your full ingredient list (INCI) and scan it against all Annex II–VI entries. The tool highlights any ingredients that match restricted, prohibited or allergen-flagged records. This is useful for rapid compliance screening of finished product formulas or raw material declarations.
Source note for Annex II record Nitrosamines e.g. Dimethylnitrosoamine; Nitrosodipropylamine; 2,2'-(Nitrosoimino)bisethanol
This page summarizes one Annex II record for Nitrosamines e.g. Dimethylnitrosoamine; Nitrosodipropylamine; 2,2'-(Nitrosoimino)bisethanol from public European Commission cosmetic materials and adds linked inventory or identifier matches when available.
Use this record page to review Annex II conditions for Nitrosamines e.g. Dimethylnitrosoamine; Nitrosodipropylamine; 2,2'-(Nitrosoimino)bisethanol, but confirm any final regulatory decision against the current official annex wording and source files.
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