Allison Tracy is a Chemicals Policy Fellow. Richard Denison, Ph.D., is a Senior Scientist.
The number of chemicals identified as “substances of very high concern” (SVHCs) in the European Union continues to grow. With today’s addition of 13 new chemicals, there are now 84 entries (representing 92 Chemical Abstract Service (CAS) registration numbers) on REACH’s Candidate List for Substances of Very High Concern for Authorisation.
The European Chemicals Agency (ECHA) added the 13 chemicals based on each chemical’s classification as Carcinogenic, Mutagenic, or Toxic for Reproduction (CMR). [UPDATE: Of the new batch, two are among the 83 TSCA workplan chemicals recently identified by EPA as priorities for risk assessment, and five were reported as being in U.S. commerce in 2006. With the new addition, a total of 48 of the 92 CAS numbers on the Candidate List were reported as in commerce in the U.S. in 2006. Additionally, 20 of the 92 CAS numbers on the Candidate List are included among the TSCA workplan chemicals.]
The following table lists each of the 13 newest SVHCs along with their CAS numbers and the reason for their inclusion on the Candidate List. It also shows which of the chemicals were reported as being in commerce in the U.S., using data from the 2006 cycle of the US EPA’s Inventory Update Reporting rule (IUR). Chemicals reported under the IUR were in U.S. commerce in 2006 above 25,000 lbs per year.
Two noteworthy additions
EPA has also prioritized two of these chemicals –shown in boldface at the top of the table – by including them on its list of TSCA Work Plan Chemicals. These chemicals were prioritized by EPA for risk assessment following a screening process based on a set of hazard and exposure criteria.
1,2-dimethoxyethane (CAS number 110-71-4) was included by ECHA on the Candidate List because it was deemed to be Toxic for Reproduction. EPA included it as a Work Plan chemical on the basis of reproductive toxicity, developmental toxicity, chronic toxicity, wide use in consumer products and high releases to the environment. Its function was reported as a solvent in the 2006 IUR, and while presence in one or more consumer products was reported, the product category(ies) were designated as “Other”, leaving its specific use or uses unknown.
TGIC (CAS number 2451-62-9) was included by ECHA on the Candidate List due to its classification as a mutagen. EPA included it as a Work Plan chemical on the basis of reproductive toxicity, mutagenicity, acute toxicity from inhalation exposures, wide use in consumer products, and estimated high releases to the environment. It is also moderately persistent in the environment. In the 2006 IUR, TGIC was reported to function as an adhesive and binding agent that is used in paints and coatings manufacturing.
|Substance name||CAS number||Reason for inclusion on the Candidate List||Reported on the 2006 IUR?|
|1,2-dimethoxyethane; ethylene glycol dimethyl ether (EGDME)||110-71-4||Toxic for Reproduction||1 to <10 million lbs/ year|
|1,3,5-Tris(oxiran-2-ylmethyl-1,3,5-triazinine-2,4,6-trione (TGIC)||2451-62-9||Mutagenic||1 to <10 million lbs/ year|
|[4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride (C.I. Basic Violet 3) [with ≥ 0.1% of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2)]||548-62-9||Carcinogenic||Not reported on 2006 IUR*|
|1,3,5-tris[(2S and 2R)-2,3-epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione (β-TGIC)||59653-74-6||Mutagenic||Not reported on 2006 IUR*|
|1,2-bis(2-methoxyethoxy)ethane (TEGDME; triglyme)||112-49-2||Toxic for Reproduction||Not reported on 2006 IUR*|
|4,4'-bis(dimethylamino)-4"-(methylamino)trityl alcohol [with ≥ 0.1% of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2)]||561-41-1||Carcinogenic||Not reported on 2006 IUR*|
|Lead(II) bis(methanesulfonate)||17570-76-2||Toxic for Reproduction||Not reported on 2006 IUR*|
|Diboron trioxide||1303-86-2||Toxic for Reproduction||1 to < 10 million lbs/ year|
|α,α-Bis[4-(dimethylamino)phenyl]-4 (phenylamino)naphthalene-1-methanol (C.I. Solvent Blue 4) [with ≥ 0.1% of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2)]||6786-83-0||Carcinogenic||<500,000 lbs/ year|
|4,4'-bis(dimethylamino)benzophenone (Michler’s ketone)||90-94-8||Carcinogenic||Not reported on 2006 IUR*|
|N,N,N',N'-tetramethyl-4,4'-methylenedianiline (Michler’s base)||101-61-1||Carcinogenic||Not reported on 2006 IUR*|
|[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene] dimethylammonium chloride (C.I. Basic Blue 26) [with ≥ 0.1% of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2)]||2580-56-5||Carcinogenic||Not reported on 2006 IUR*|
|Formamide||75-12-7||Toxic for Reproduction||1 to < 10 million lbs/ year|
* Chemicals not reported on the 2006 IUR may not appear because: a) they were not manufactured or imported; b) they were manufactured or imported in amounts less than 25,000 lbs/ year; or c) the chemical identities were claimed confidential.