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Annex II Entry 722 CMR15/10/2010

4,4'-Bi-o-toluidine dihydrochloride

4,4'-Bi-o-toluidine dihydrochloride 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: 722
CMR

Chemical identity and properties

PubChem 2D chemical structure for CAS 612-82-8
CAS 612-82-8PubChem CID 108938

3,3'-Dimethylbenzidine dihydrochloride

3,3'-Dimethylbenzidine dihydrochloride can cause cancer according to The National Toxicology Program. — California Office of Environmental Health Hazard Assessment (OEHHA)

IUPAC name
4-(4-amino-3-methylphenyl)-2-methylaniline;dihydrochloride
Molecular formula
C14H18Cl2N2
Molecular weight
285.2 g/mol
Exact mass
284.0847040 Da
Topological polar surface area
52.0 Ų
Hydrogen-bond donors
4
Hydrogen-bond acceptors
2
Covalent units
3
Defined stereocentres
0

Also known as

o-Tolidine dihydrochloride[1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethyl-, dihydrochloride5MSK350KD8UNII-5MSK350KD8NSC-11223CCRIS 3495O-TOLIDINE DIHYDROCHLORIDE [MI]EINECS 210-322-5
16 more reported names
NSC 11223(1,1'-Biphenyl)-4,4'-diamine, 3,3'-dimethyl-, dihydrochloride2,3'-Dimethylbiphenyl-4,4'-diamine dihydrochloride4,4'-Diamino-3,3'-dimethylbiphenyl dihydrochlorideDMB2HCloTolidine dihydrochlorideRefChem:906994,4'Biotoluidine dihydrochlorideBenzidine, 3,3'dimethyl, dihydrochloride4,4'Diamino3,3'dimethylbiphenyl dihydrochloride(1,1'Biphenyl)4,4'diamine, 3,3'dimethyl, dihydrochloride(1,1'Biphenyl)4,4'diamine, 3,3'dimethyl, hydrochloride (1:2)210-322-5DMB dihydrochlorideBenzidine, 3,3'-dimethyl-, dihydrochloride3,3'-Dimethylbenzidine.2HCl
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External database identifiers

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

4,4'-Bi-o-toluidine dihydrochloride

Regulatory information

Regulation

(EC) 2009/1223

See every entry this act set

SCCS opinions

CMR

CategoryCarcinogenicMutagenicReprotoxic
Cat. 1B✓——

Key data

CAS
612-82-8
EC
210-322-5
Annex
II
Entry number
722

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

Annex II 727
Nearby record in the same annex

Azobenzene

CAS: 103-33-3
EC: 203-102-5

What Annex II means for 4,4'-Bi-o-toluidine dihydrochloride

4,4'-Bi-o-toluidine dihydrochloride 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. 4,4'-Bi-o-toluidine dihydrochloride 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 612-82-8 is the unique numerical identifier assigned to 4,4'-Bi-o-toluidine dihydrochloride 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.

4,4'-Bi-o-toluidine dihydrochloride 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 4,4'-Bi-o-toluidine dihydrochloride

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

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