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We have addressed the toxicology data and NOELs used, the concentration of beta-PGME in various end-user products, the model used to calculate exposures and the risk characterisation performed for the various scenarios.

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The European producers of Glycol Ethers, members of OSPA, wish to recall by this charter the commitments and actions that they are undertaking since several years in order to avoid the risks linked to glycol ethers classified toxic for reproduction.

GLYCOL ETHERS

Glycol Ethers are solvents which constitute of a varied family of more than 30 different substances.
They have similar physical properties but do not demonstrate all the same technical characteristics nor the same toxicity profiles. This is why they are not interchangeable and this is why a large number of Glycol Ethers are put on the market for sale. Some Glycol Ethers are sold in large; others only in low quantities and several are even not produced at all.

THE GLYCOL ETHERS CLASSIFIED TOXIC FOR REPRODUCTION

Nine have been classified as “toxic for reproduction” of category 2^a. None of these substances are produced in France.
Six of them have been commercialised¹, four of which only in marginal quantities. EGMEA/EGDEE are not produced² and the méthoxy-2 propanol-1³ is never produced as such, yet occurs as an impurity at the production of méthoxy-1 propanol-2⁴.
Furthermore, DEGME⁵ is classified as “toxic for reproduction” category 3^b.

The use in France of glycol ethers classified toxic for reproduction

An active substitution policy for glycol ethers classified as “toxic for reproduction” has been put in place. This has allowed a substantial reduction of their use compared to the early 1990s where the annual consumption in France had reached several thousand tons. Furthermore, several producers have stopped production. The amount of Glycol Ethers classified toxic for reproduction of category 2 used in France in 2002 corresponds to ~1% of the quantities of 1993.

There remains however some essential industrial applications for which no substitution has been found to date. In 2004 the sales in France were:

^a toxic effects at the animal
^b toxic effects suspected, insufficient evidence
¹ ethylene glycol monoethyl ether (EGEE) (CAS 110-80-5) and its acetate (EGEEA) (CAS 111-15-9), ethylene glycol mono-methyl ether (EGME) (CAS 109-86-4), ethylene glycol di-methyl ether (EGDME) (CAS 110-71-4), di-ethylene glycol di-methyl ether (DEGDME) (CAS 111-96-6) and tri-ethylene glycol di-methyl ether (TEGDME) (CAS 11249-2).
² ethylene glycol mono-methyl ether acetate (EGMEA) (CAS 110-49-6)

³ CAS 1589-47-5
⁴ CAS 107-98-2
⁵ di-ethylene glycol methyl ether (DEGME) (CAS 11-77-3)

The Environmental Protection Agency (EPA) announced on November 5, 2003 that it would shortly be publishing in the Federal Register its proposal to delist ethylene glycol butyl ether (EGBE) from the Clean Air Act Amendments’ (CAAA) list of Hazardous Air Pollutants (HAPs). An EPA decision to delist would mean that EGBE would no longer be subject to the CAAA’s Maximum Achievable Control Technology (MACT) requirements, or its residual risk and other requirements. EPA will be receiving comments for 60 days after Federal Register publication and will hold a public hearing if requested.

The American Chemistry Council Ethylene Glycol Ethers Panel (ACC Panel) filed a petition in August 1997 showing why the available evidence indicated that EGBE should be delisted. EPA found the petition complete as of December 21, 1998, and sought comments on the petition on August 3, 1999 (64 Fed. Reg. 42125). All submitted comments supported the petition.

EPA is directed under the CAAA to delist HAPs if there are “adequate data on the health and environmental effects of the substance to determine that emissions, ambient concentrations, bioaccumulation or deposition of the substance may not reasonably be anticipated to cause any adverse effects to human health or adverse environmental effects,” Section 112(b)(3)(C). The Federal Register proposal (available at http://www.epa.gov/airlinks/airlinks1.html) indicates the Agency has found the data on EGBE meets this standard.

EPA finds wide margins of safety (“Hazard Quotients”) between estimated maximum exposures and lowest toxicity effect levels. Specifically, EPA states maximum human exposures will be 16 to 50 times lower than the lowest level expected to pose any risk to human health. Thus, EPA concludes: “[W]e judge that the potential for human health and environmental effects [from EGBE] is sufficiently low to provide reasonable assurance that such adverse effects will not occur.”

EPA also notes that exposure estimates were “at least a factor of 2″ higher than what the Agency expects would be the maximum individual exposure and “at least an order of magnitude” less than the Agency’s Reference Concentration (RfC) (the level below which the Agency does not expect any adverse health effects).

EPA also reviewed the numerous toxicity studies of EGBE. The proposal includes extensive Agency scientific interpretation of all the toxicity studies (including lifetime animal studies that investigated chronic effects including cancer). The Agency finds these data fully support its RfC for EGBE issued in 1999. EPA includes in the proposal it’s most recent interpretation of the NTP study of cancer in mice and rats and concludes that extensive data show that its 1999 RfC is “sufficient” to prevent any cancer risk to humans.”

November 2003

This information is brought to you by the member companies of the American Chemistry Council CHEMSTAR Ethylene Glycol Ethers Panel: The Dow Chemical Company, Eastman Chemical Company, Equistar Chemicals, LP, and Shell Chemical Company. For more information, please call your supplier representative, or Dr. Susan A. Lewis, Manager of the EGE Panel at (703) 741-5635 or by E-Mail: Susan_Lewis@americanchemistry.com.

Occup. Environ. Med. 2007;64;467-473; originally published online 1 Mar 2007;
doi:10.1136/oem.2005.023952

Objectives: Apparent increases in human male reproductive disorders, including low sperm production, may have occurred because of increased chemical exposure. Various glycol ether-based solvents have pronounced adverse effects on sperm production and male fertility in laboratory animals. The authors investigated the effects of past and current exposure to glycol ether-containing products on semen quality and reproductive hormones among men employed by the Paris Municipality.

Methods: Between 2000 and 2001 the authors recruited 109 men who gave semen, blood and urine samples and underwent an andrological examination. Information on lifestyle, occupation, exposure and medical history was obtained by interview. According to their job and chemical products used during the period 1990–2000, men were classified as either occupationally exposed or non-exposed. Current exposure levels to glycol ethers at the time of the study were evaluated by biological monitoring of six urinary metabolites.

Results: Previous exposure to glycol ethers was associated with an increased risk for sperm concentration, for rapid progressive motility and for morphologically normal sperm below the World Health Organization semen reference values. No effect of previous glycol ether exposure on hormones levels was observed. By contrast, current glycol ether exposure levels were low and not correlated with either seminal quality or hormone levels.

Conclusions: This study suggests that most glycol ethers currently used do not impact on human semen characteristics. Those that were more prevalent from the 1960s until recently may have long lasting negative effects on human semen quality.

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