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Annex II Entry 1161 CMR15/10/2010

N,N,N',N'-Tetramethyl-4,4'-methylenedianiline

N,N,N',N'-Tetramethyl-4,4'-methylenedianiline is listed in Annex II as a prohibited substance for cosmetic products placed on the EU market.

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Prohibited substance— Annex II, EU Regulation 1223/2009
Entry: 1161
CMR

Chemical identity and properties

PubChem 2D chemical structure for CAS 101-61-1
CAS 101-61-1PubChem CID 7567

Bis(p-(dimethylamino)phenyl)methane

4,4'-Methylenebis(N,N-dimethylaniline) is a diarylmethane. — ChEBI

IUPAC name
4-[[4-(dimethylamino)phenyl]methyl]-N,N-dimethylaniline
Molecular formula
C17H22N2
Molecular weight
254.37 g/mol
Exact mass
254.178298710 Da
XLogP3
3.9
Topological polar surface area
6.5 Ų
Hydrogen-bond donors
0
Hydrogen-bond acceptors
2
Covalent units
1
Defined stereocentres
0

Also known as

4,4'-Methylenebis(N,N-dimethylaniline)Michler's baseMethane baseBis[4-(dimethylamino)phenyl]methaneMichler's hydrideMethylene baseMichler's methaneReduced michler'S ketone
16 more reported names
4,4'-Bis(dimethylamino)diphenylmethaneArnold's baseTetramethyldiaminodiphenylmethaneBis(4-(N,N-dimethylamino)phenyl)methane4,4'-TetramethyldiaminodiphenylmethaneBaze michlerova4,4'-Methylenebis(N,N-dimethyl)benzenamine4,4'-(Dimethylamino)diphenylmethanep,p-Dimethylaminodiphenylmethanep,p'-Bis(dimethylamino)diphenylmethaneNCI-C01990Diphenylmethane, tetramethyldiamino-p,p-TetramethyldiaminodiphenylmethaneN,N'-Tetramethyldiaminodiphenylmethane4,4'-Methylenebis(N,N-dimethylbenzenamine)BAZE michlerova [Czech]
Open full PubChem recordPubChem annotations3D structure image
External database identifiers

Evidence from additional scientific databases

EMBL-EBI ChEBI
Exact identifier matchCHEBI:34370

4,4'-Methylenebis(N,N-dimethylaniline)

Formula
C17H22N2
Average mass
254.377 g/mol
Monoisotopic mass
254.17830 Da
Formal charge
0
  • diarylmethane — is a (CHEBI:51614)
  • diarylmethane — is a (CHEBI:51614)
Additional curated names
4,4'-Methylenebis(N,N-dimethylaniline)Michler's base
Cross-references from this source
  • CAS: 101-61-1 — KEGG COMPOUND
  • MANUAL_X_REF: C14135 — KEGG COMPOUND

Mapped by: Exact CAS cross-reference in the ChEBI compound record. Source updated: 2014-07-28. Retrieved: 2026-08-31. Open source record

NIH PubChem PUG-View
Exact identifier match7567

Attributed physical-property, hazard, environmental and use annotations.

  • Density: 1.14 at 68 °F (NTP, 1992) - Denser than water; will sink Source: CAMEO Chemicals
  • 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: European Chemicals Agency (ECHA)
  • GHS Hazard Statements: H350 (100%): May cause cancer [Danger Carcinogenicity]; H400 (100%): Very toxic to aquatic life [Warning Hazardous to the aquatic environment, acute hazard]; H410 (100%): Very toxic to aquatic life with long lasting effects [Warning Hazardous to the aquatic environment, long-term hazard] Source: European Chemicals Agency (ECHA)
  • Precautionary Statement Codes: P203, P273, P280, P318, P391, 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 46 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]; 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, P280, P318, P319, P405, and P501 (click each P-code to see the statement) Source: NITE-CMC
  • Signal: Warning Source: NITE-CMC
  • GHS Hazard Statements: H303: May be harmful if swallowed [Warning Acute toxicity, oral]; H351: Suspected of causing cancer [Warning Carcinogenicity] Source: NITE-CMC
  • Precautionary Statement Codes: P203, P280, P301+P317, P318, P405, and P501 (click each P-code to see the statement) Source: NITE-CMC
  • Environmental Bioconcentration: Bis(p-(dimethylamino)phenyl)methane, present at 0.50 and 0.050 mg/L resulted in BCF of 629 and 423, respectively, in fish using carp (Cyprinus carpio) which were exposed over an 4-week period(1). According to a classification scheme(2), these BCF values suggest that bioconcentration in aquatic organisms is high(SRC). Source: Hazardous Substances Data Bank (HSDB)
  • Environmental Fate: TERRESTRIAL FATE: Based on a classification scheme(1), a log Koc of 3.26(2) (Koc of 9,100(SRC)), determined from a structure estimation method(2), indicates that bis(p-(dimethylamino)phenyl)methane is expected to be immobile in soil(SRC). Volatilization of bis(p-(dimethylamino)phenyl)methane from moist soil surfaces is not expected to be an important fate process(SRC) given an estimated Henry's Law constant of 1.2X10-7 atm-cu m/mole(SRC), using a fragment constant estimation method(3). Bis(p-(dimethylamino)phenyl)methane is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 3.3X10-6 mm Hg at 25 °C(SRC), determined from a fragment constant method(4). A 0% of theoretical BOD using activated sludge in the Japanese MITI test(5) suggests that biodegradation is not an important environmental fate process in soil(SRC). Source: Hazardous Substances Data Bank (HSDB)
  • Environmental Fate: AQUATIC FATE: Based on a classification scheme(1), a log Koc of 3.26(2) (Koc of 9,100(SRC)), determined from a structure estimation method(2), indicates that bis(p-(dimethylamino)phenyl)methane is 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 1.2X10-7 atm-cu m/mole(SRC), developed using a fragment constant estimation method(4). According to a classification scheme(5), BCF values of 423 and 629(8), suggest that bioconcentration in aquatic organisms is high(SRC). A 0% of theoretical BOD using activated sludge in the Japanese MITI test(6) suggests that biodegradation is not an important environmental fate process in water(SRC). 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), bis(p-(dimethylamino)phenyl)methane, which has an estimated vapor pressure of 3.3X10-6 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 bis(p-(dimethylamino)phenyl)methane 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 1 hour(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 bis(p-dimethylamino)phenyl)methane may be removed from the air by wet or dry deposition(SRC). Bis(p-dimethylamino)phenyl)methane does not contain chromophores that absorb at wavelengths >290 nm(4), and therefore is not expected to be susceptible to direct photolysis by sunlight(SRC). 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
SourceResultChecked
EMBL-EBI ChEBIExact match2026-08-31
NIH PubChem PUG-ViewExact match2026-08-31

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

N,N,N',N'-Tetramethyl-4,4'-methylenedianiline

Regulatory information

Regulation

(EC) 2009/1223

See every entry this act set

SCCS opinions

CMR

CategoryCarcinogenicMutagenicReprotoxic
Cat. 1B✓——

Key data

CAS
101-61-1
EC
202-959-2
Annex
II
Entry number
1161

Direct matches are limited for this record, so nearby entries from Annex II are shown as well.

Annex II 1157
Nearby record in the same annex

Azafenidin (ISO)

CAS: 68049-83-2
EC: 620-425-0
Annex II 1165
Nearby record in the same annex

2-Nitrotoluene

CAS: 88-72-2
EC: 201-853-3
Annex II 1167
Nearby record in the same annex

Naphthalene

CAS: 91-20-3
EC: 202-049-5

What Annex II means for N,N,N',N'-Tetramethyl-4,4'-methylenedianiline

N,N,N',N'-Tetramethyl-4,4'-methylenedianiline 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. N,N,N',N'-Tetramethyl-4,4'-methylenedianiline 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 101-61-1 is the unique numerical identifier assigned to N,N,N',N'-Tetramethyl-4,4'-methylenedianiline 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.

N,N,N',N'-Tetramethyl-4,4'-methylenedianiline 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.
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Source note for Annex II record N,N,N',N'-Tetramethyl-4,4'-methylenedianiline

This page summarizes one Annex II record for N,N,N',N'-Tetramethyl-4,4'-methylenedianiline 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 N,N,N',N'-Tetramethyl-4,4'-methylenedianiline, but confirm any final regulatory decision against the current official annex wording and source files.

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