Annex II
Entry 1550
CMR30/07/2020
Leucomalachite green; N,N,N',N'-tetramethyl-4,4'-benzylidenedianiline
Leucomalachite green; N,N,N',N'-tetramethyl-4,4'-benzylidenedianiline 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: 1550
CMR
Chemical identity and properties
CAS 129-73-7PubChem CID 67215
Leucomalachite green
Leucomalachite green is a benzenoid aromatic compound. — ChEBI
- IUPAC name
- 4-[[4-(dimethylamino)phenyl]-phenylmethyl]-N,N-dimethylaniline
- Molecular formula
- C23H26N2
- Molecular weight
- 330.5 g/mol
- Exact mass
- 330.209598838 Da
- XLogP3
- 5.3
- Topological polar surface area
- 6.5 Ų
- Hydrogen-bond donors
- 0
- Hydrogen-bond acceptors
- 2
- Covalent units
- 1
- Defined stereocentres
- 0
Also known as
Malachite green leucoMalachite green leuco base4,4'-Bis(dimethylamino)triphenylmethaneC.I. Basic Green 4, leuco baseTetramethyldiaminotriphenylmethaneBis(p-dimethylaminophenyl)phenylmethanep,p'-Benzylidenebis(N,N-dimethylaniline)4,4'-Benzylidene bis(N,N-dimethylaniline)
16 more reported names
Aniline, 4,4'-benzylidenebis(N,N-dimethyl-Bis(p-(N,N-dimethylamino)phenyl)phenylmethane4,4'-Bis(N,N-dimethylaminophenyl)phenylmethaneBenzenamine, 4,4'-(phenylmethylene)bis[N,N-dimethyl-Bis(4,4'-(dimethylamino)phenyl)phenyl methane4,4'-(Phenylmethylene)bis(N,N-dimethylbenzenamine)4,4'-benzylidenebis(N,N-dimethylaniline)NSC-363798U61G37Z20Benzenamine, 4,4'-(phenylmethylene)bis(N,N-dimethyl-Bis[p-(N,N-dimethylamino)phenyl]phenylmethaneBis[4,4'-(dimethylamino)phenyl]phenyl methaneRefChem:153083204-961-9Leuco malachite greenLeucoMalachiteGreen
External database identifiers
- ChEBI:CHEBI:181416
- ChEMBL:CHEMBL1898627
- EPA DTXSID:DTXSID7031531
- PubMed:26558467
- PubMed:21578770
- PubMed:16904259
- PubMed:12351145
- PubMed:9760285
Evidence from additional scientific databases
NIH PubChem PUG-View
Exact identifier match67215
Attributed physical-property, hazard, environmental and use annotations.
- Color/Form: Off-white to light-brown powder Source: Hazardous Substances Data Bank (HSDB)
- Color/Form: Needles or leaflets from alcohol, benzene Source: Hazardous Substances Data Bank (HSDB)
- Melting Point: 102 °C Source: Hazardous Substances Data Bank (HSDB)
- Physical Description: Reduced form of malachite green; [Merck Index] Source: Haz-Map, Information on Hazardous Chemicals and Occupational Diseases
- Solubility: Very soluble in benzene, ethyl ether Source: Hazardous Substances Data Bank (HSDB)
- Solubility: Solubilities (mg/mL): 30 ethyleneglycol monomethyl ether; 4 ethanol Source: Hazardous Substances Data Bank (HSDB)
- IARC Carcinogenic Agent: Leucomalachite green 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 129: (2022) Gentian Violet, Leucogentian Violet, Malachite Green, Leucomalachite Green, and CI Direct Blue 218 Source: International Agency for Research on Cancer (IARC)
- Publication Year: 2022 online Source: International Agency for Research on Cancer (IARC)
- Evaluation Year: 2021 Source: International Agency for Research on Cancer (IARC)
- Substance: Leucomalachite Green Source: NTP Technical Reports
- NTP Technical Report: TR-527: Toxicology and Carcinogenesis Studies of Malachite Green Chloride and Leucomalachite Green (CASRNs 569-64-2 and 129-73-7) in F344/N Rats and B6C3F1 Mice (Feed Studies) (2005 ) Source: NTP Technical Reports
- Peer Review Date: 02/17/04 Source: NTP Technical Reports
- Conclusion for Male Rat: Equivocal Evidence Source: NTP Technical Reports
- Conclusion for Female Rat: Equivocal Evidence Source: NTP Technical Reports
- Conclusion for Male Mice: Chemical Not Tested in Species/Sex Source: NTP Technical Reports
- Conclusion for Female Mice: Some Evidence Source: NTP Technical Reports
- Signal: Warning Source: Regulation (EC) No 1272/2008 of the European Parliament and of the Council
- GHS Hazard Statements: H341: Suspected of causing genetic defects [Warning Germ cell mutagenicity]; H351: Suspected of causing cancer [Warning 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: H302 (96.2%): Harmful if swallowed [Warning Acute toxicity, oral]; H311 (15.4%): Toxic in contact with skin [Danger Acute toxicity, dermal]; H315 (15.4%): Causes skin irritation [Warning Skin corrosion/irritation]; H331 (15.4%): Toxic if inhaled [Danger Acute toxicity, inhalation]; H332 (15.4%): Harmful if inhaled [Warning Acute toxicity, inhalation]; H400 (96.2%): Very toxic to aquatic life [Warning Hazardous to the aquatic environment, acute hazard] Source: European Chemicals Agency (ECHA)
- Precautionary Statement Codes: P261, P262, P264, P270, P271, P273, P280, P301+P317, P302+P352, P304+P340, P316, P317, P321, P330, P332+P317, P361+P364, P362+P364, P391, P403+P233, 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 52 reports by companies from 6 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: H341: Suspected of causing genetic defects [Warning Germ cell mutagenicity]; H351: Suspected of causing cancer [Warning Carcinogenicity]; H361: Suspected of damaging fertility or the unborn child [Warning Reproductive toxicity]; H372: Causes damage to organs through prolonged or repeated exposure [Danger Specific target organ toxicity, repeated exposure]; H373: May causes damage to organs through prolonged or repeated exposure [Warning Specific target organ toxicity, repeated exposure] Source: NITE-CMC
- Precautionary Statement Codes: P203, P260, P264, P270, P280, P318, P319, P405, and P501 (click each P-code to see the statement) Source: NITE-CMC
- Signal: Warning Source: Hazardous Chemical Information System (HCIS), Safe Work Australia
- GHS Hazard Statements: H341: Suspected of causing genetic defects [Warning Germ cell mutagenicity]; H351: Suspected of causing cancer [Warning Carcinogenicity] Source: Hazardous Chemical Information System (HCIS), Safe Work Australia
- Environmental Bioconcentration: An estimated BCF of 2800 was calculated in fish for leucomalachite green(SRC), using an estimated log Kow of 5.72(1) and a regression-derived equation(2). According to a classification scheme(3), this BCF suggests the potential for bioconcentration in aquatic organisms is very high(SRC), provided the compound is not metabolized by the organism(SRC). Source: Hazardous Substances Data Bank (HSDB)
- Environmental Fate: TERRESTRIAL FATE: Based on a classification scheme(1), an estimated Koc value of 9.8X10+4(SRC), determined from a structure estimation method(2), indicates that leucomalachite green is expected to be immobile in soil(SRC). The estimated pKa of leucomalachite green is 5.46(3), indicating that this compound will exist partially in the cation form in the environment and cations generally adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts(4). Volatilization of the neutral species from moist soil surfaces is not expected to be an important fate process(SRC) given an estimated Henry's Law constant of 9.8X10-9 atm-cu m/mole(SRC), using a fragment constant estimation method(5). Leucomalachite green is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 1.9X10-7 mm Hg at 25 °C(SRC), determined from a fragment constant method(6). Biodegradation data in soil were not available(SRC, 2012). Source: Hazardous Substances Data Bank (HSDB)
- Environmental Fate: AQUATIC FATE: Based on a classification scheme(1), an estimated Koc value of 9.8X10+4(SRC), determined from a structure estimation method(2), indicates that leucomalachite green is expected to adsorb to suspended solids and sediment(SRC). Volatilization of the neutral species from water surfaces is not expected(3) based upon an estimated Henry's Law constant of 9.8X10-9 atm-cu m/mole(SRC), developed using a fragment constant estimation method(4). The estimated pKa of 5.72(5) indicates leucomalachite green will exist partially in the cation form at pH values of 5 to 9 and, therefore, volatilization from water surfaces is not expected to be an important fate process(SRC). According to a classification scheme(6), an estimated BCF of 2800(SRC), from an estimated log Kow of 5.72(7) and a regression-derived equation(8), suggests the potential for bioconcentration in aquatic organisms is very high, provided the compound is not metabolized by the organism(SRC). Biodegradation data in water were not available(SRC, 2012). 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), leucomalachite green, which has an estimated vapor pressure of 1.9X10-7 mm Hg at 25 °C(SRC), determined from a fragment constant method(2), will exist in both the vapor and particulate phases in the ambient atmosphere. Vapor-phase leucomalachite green 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 0.6 hours(SRC), calculated from its rate constant of 2.1X10-10 cu cm/molecule-sec at 25 °C(SRC) that was derived using a structure estimation method(3). Particulate-phase leucomalachite green may be removed from the air by wet or dry deposition(SRC). Leucomalachite green contains chromophores that absorb at wavelengths >290 nm(4) and, therefore, may be susceptible to direct photolysis by sunlight(SRC). Source: Hazardous Substances Data Bank (HSDB)
- Sources/Uses: Used to dye silk, wool, jute, leather, and cotton (after mordanting); Also used as a biological stain, reagent, pH indicator, fungicide, and parasiticide; [Merck Index] Source: Haz-Map, Information on Hazardous Chemicals and Occupational Diseases
- Industrial Processes with risk of exposure: Textiles (Printing, Dyeing, or Finishing) [Category: Industry] Source: Haz-Map, Information on Hazardous Chemicals and Occupational Diseases
- Uses: Reagent for the quantitative colorimetric microdetermination of hemoglobin and other heme compounds 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.
Record details
Chemical name
Leucomalachite green; N,N,N',N'-tetramethyl-4,4'-benzylidenedianiline
Chemical / IUPAC name
Leucomalachite green; N,N,N',N'-tetramethyl-4,4'-benzylidenedianiline
Regulatory information
CMR
| Category | Carcinogenic | Mutagenic | Reprotoxic |
|---|---|---|---|
| Cat. 2 | ✓ | ✓ | — |
Key data
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What Annex II means for Leucomalachite green; N,N,N',N'-tetramethyl-4,4'-benzylidenedianiline
Leucomalachite green; N,N,N',N'-tetramethyl-4,4'-benzylidenedianiline 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).
- This substance has CMR classification. Review the CMR table above and verify current Annex II/III status before use.
Frequently asked questions
Yes. Leucomalachite green; N,N,N',N'-tetramethyl-4,4'-benzylidenedianiline 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 129-73-7 is the unique numerical identifier assigned to Leucomalachite green; N,N,N',N'-tetramethyl-4,4'-benzylidenedianiline 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.
Leucomalachite green; N,N,N',N'-tetramethyl-4,4'-benzylidenedianiline has a CMR (carcinogenic, mutagenic or reprotoxic) classification under EU CLP Regulation. Under Article 15 of EU Cosmetics Regulation 1223/2009, CMR substances of category 1A or 1B are prohibited in cosmetics unless specifically permitted. Category 2 CMR substances may be used only if assessed safe by the SCCS. Always verify current annex status and any applicable derogations before use.
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 Leucomalachite green; N,N,N',N'-tetramethyl-4,4'-benzylidenedianiline
This page summarizes one Annex II record for Leucomalachite green; N,N,N',N'-tetramethyl-4,4'-benzylidenedianiline 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 Leucomalachite green; N,N,N',N'-tetramethyl-4,4'-benzylidenedianiline, but confirm any final regulatory decision against the current official annex wording and source files.
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