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OECD SIDS DIPROPYLENE GLYCOL METHYL ETHER FOREWORD INTRODUCTION DIPROPYLENE GLYCOL METHYL ETHER CAS N°: 34590-94-8 (Isomers: 13429-07-7, 20324-32-7; 13588-28-8; and 55956-21-3) UNEP PUBLICAIONS 1 OECD SIDS DIPROPYLENE GLYCOL METHYL ETHER SIDS Initial Assessment Report for 12th SIAM (Paris, France, 27-29 June 2001) Chemical Name : DIPROPYLENE GLYCOL METHYL ETHER (DPGME) CAS No: Isomers: 34590-94-8 13429-07-7, 20324-32-7; 13588-28-8; and 55956-21-3 Sponsor Country: U.S.A National SIDS Contact Point in Sponsor Country: US EPA Contact person: Address: Dr. Oscar Hernandez Ariel Rios Building 1200 Pennsylvania Avenue, N.W. Washington, DC 20460 U.S.A. HISTORY: COMMENTS: Deadline for circulation: Date of Circulation: 12/4/2001 (updated November 2001) 2 UNEP PUBLICAIONS OECD SIDS DIPROPYLENE GLYCOL METHYL ETHER SIDS INITIAL ASSESSMENT PROFILE CAS No. 34590-94-8 (isomers: 13429-07-7, 20324-32-7; 13588-28-8; and 55956-21-3) Chemical Name Dipropylene Glycol Methyl Ether Structural Formula CH3-(OC 3H6)2-OH RECOMMENDATIONS The chemical is currently of low priority for further work, based on the low hazard profile. SUMMARY CONCLUSIONS OF THE SIAR Human Health Commercial Dipropylene Glycol Methyl Ether (DPGME) is a mixture of four isomers. DPGME exhibits low acute toxicity by the oral, dermal, and inhalation routes. The oral LD50 ranges 5180-5400 mg/kg b.w. in rats to 7500 mg/kg b.w. in dogs. Dermal LD50 values were reported to range from 9500 to >19000 mg/kg b.w. in rabbits. Acute inhalation exposures to 500 ppm (3000 mg/m 3, highest attainable concentration) DPGME produced no lethality and mild, but reversible narcosis in rats. In animal and human studies, DPGME is neither a skin sensitizer nor a skin irritant, and was only slightly irritating to the eye. In repeated dose inhalation studies, NOAELs of >50 ppm to 200 ppm (> 303 mg/m3 to 12 12 mg/m 3) have been observed using rats, mice, rabbits, guinea pigs, and monkeys. Effects observed at higher dose levels (1818 mg/m 3 to 2424 mg/m 3; 300 – 400 ppm) showed signs of central nervous system depression and adaptive liver changes. In rats exposed to up to 1000 mg/kg-day DPGME via gavage for 4 weeks, tentative salivation (immediately after dosing) and adaptive liver changes were observed in animals exposed to the highest dose. No effects were observed in rats exposed to 200 mg/kg-day. Studies in rats and rabbits showed that DPGME is not teratogenic (two inhalation studies with NOAELs of 1818 mg/m 3; 300 ppm). It should be noted that the beta isomer of PGME is known developmental toxicant. This isomer is unlikely to be a metabolite of DPGME. The available data indicate that DPGME is not genotoxic. Information collected for a structurally similar chemical (PGME) suggests that DPGME is not a reproductive toxicant, and is not carcinogenic. Additionally, no effects were seen on the testes and ovaries in a 90-day repeat dose inhalation toxicity study on DPGME. Environment DPGME is not persistent in the environment and is not expected to bioaccumulate in food webs. DPGME has a water solubility value of 1000 mg/L, a vapor pressure of 0.37 hPa and a log Kow of 0.0061. The half-life of DPGME in air was measured at 5.3 hours and is estimated to be 3.4 hours due to direct reactions with photochemically generated hydroxyl radicals. DPGME is readily biodegraded under aerobic conditions, but only slightly degraded under anaerobic conditions. Although environmental monitoring data are not available for DPGME, fugacity-based modelling indicates that DPGME is likely to partition to water compartments in the environment (surface water, groundwater). Acute toxicity testing in fish, invertebrates, and algae indicate a low order of toxicity with effect concentrations exceeding 1000 mg/L. Applying an uncertainty factor of 100 to the 48hour LC50 value of 1919 mg/L for Daphnia, a PNEC of 19 mg/L was derived. Exposure Production in the U.S. was estimated at 35 million pounds (16 thousand tonnes) for 2000. DPGME is used in the manufacture of a wide variety of industrial and commercial products, including paints, varnishes, inks, and cleaners. In the US in 1999, DPGME was used as follows: 58% paints/coatings/inks, 28% cleaners, 10% DPGME acetate production, and 3% miscellaneous production. UNEP PUBLICAIONS 3 OECD SIDS DIPROPYLENE GLYCOL METHYL ETHER NATURE OF FURTHER WORK RECOMMENDED No further work is recommended. 4 UNEP PUBLICAIONS OECD SIDS DIPROPYLENE GLYCOL METHYL ETHER FULL SIDS SUMMARY CAS NO: 34590-94-8 SPECIES PROTOCOL RESULTS PHYS ICAL-CHEMICAL 2.1 Melting Point -- -- -83 °C 2.2 Boiling Point -- -- 190°C 2.3 Density -- -- 0.948 g/cm3 2.4 Vapour Pressure -- -- 0.37 hPa at 20°C 2.5 Partition Coefficient (Log Ko w) -- -- 0.0061 2.6 A. Water Solubility -- -- Miscible pH -- -- No data pKa Oxidation: Reduction Potential -- -- No data -- -- No data B. 2.12 ENVIRONMENTAL FATE AND PATHWAY 3.1.1 Photodegradation -- Measured 5.3 hours 3.1.2 Stability in Water -- Measured Little to no degradation over short periods of time. 3.2 Monitoring Data -- Measured 3.3 Transport and Distribution Biodegradation --- Fugacity estimates Measured Limited occupational air sample data, product formulations generally contain 2-25%. Primarily distributes to water compartments. Pimephales promelas Daphnia magna 96-hour lethality 48-hour lethality LC50 >10,000 mg/L Selenastrum capricornum Daphnia magna 3-4-day growth 22-day reproduction EC10 = 133 mg/L EC50 > 969 mg/L NOAEL = 0.5 mg/L LOAEL > 0.5 mg/L -- -- No data 3.5 Readily degraded under aerobic conditions; limited degradation under anaerobic conditions. ECOTOXICOLOGY 4.1 Acute/Prolonged Toxicity to Fish 4.2 Acute Toxicity to Aquatic Invertebrates (Daphnia Toxicity to Aquatic Plants e.g. Algae 4.3 4.5.2 Chronic Toxicity to Aquatic Invertebrates (Daphnia) 4.6.1 Toxicity to Soil Dwelling Organisms UNEP PUBLICAIONS LC50 = 1919 mg/L 5 OECD SIDS DIPROPYLENE GLYCOL METHYL ETHER CAS NO: 34590-94-8 4.6.2 4.6.3 SPECIES PROTOCOL Growth RESULTS Toxicity to Terrestrial Plants Glycine max Toxicity to Other Non- Mammalian Terrestrial Species (Including Birds) -- -- No data EC50 > 500,000 mg/L NOEC = 250,000 mg/L TOXICOLOGY 5.1.1 Acute Oral Toxicity Rat Acute lethality LD50 = 5180 – 5400 mg/kg 5.1.2 Acute Inhalation Toxicity Rat Acute toxicity LOAEL = 500 ppm 5.1.3 Acute Dermal Toxicity Rabbits Acute lethality LD50 = 9500 mg/kg 5.4 R epeated Dose Toxicity Rat 4-week oral toxicity LOAEL = 1000 mg/kg Rat 13-week inhalation NOAEL = 200 ppm (1212 mg/m3) Rat 28-week inhalation LOAEL= 200 – 300 ppm (1212 mg/m 3 – 1818 mg/m 3 ) 40-60% saturated DPGME atmosphere Bacterial Test (Gene mutation) Salmonella typhimurium Mutagenicity With activation: - Non-Bacterial In Vitro Test Chinese hamster ovary cells Chromosomal aberrations With activation: - 5.6 Genetic Toxicity In Vivo -- -- 5.7 Carcinogenicity -- -- 5.8 Toxicity to Reproduction -- -- 5.9 Developmental Toxicity/ Teratogenicity Rat Inhalation Rabbit Inhalation Experience with Human Exposure Human Respiratory irritation No data; Data for similar chemical (PGME) are negative No data; Data for similar chemical (PGME) are negative Limited data; Data for similar chemical (PGME) are negative NOAEL = 300 ppm LOAEL > 300 ppm NOAEL = 300 ppm LOAEL > 300 ppm LOAEL = 35 – 75 ppm 5.5 NOAEL = 200 mg/kg Genetic Toxicity In Vitro A. B. 5.11 6 Without activation: - UNEP PUBLICAIONS Without activation: - OECD SIDS DIPROPYLENE GLYCOL METHYL ETHER SIDS Initial Assessment Report 1.0 IDENTITY Dipropylene Glycol Methyl Ether ( 34590-94-8), or DPGME, is a liquid that possesses the following physical-chemical properties and characteristics: Property Chemical Formula Molecular Weight Purity Impurities Melting Point Boiling Point Density Vapor Pressure Partition Coefficient (Log Ko w) Water Solubility g/m 3 Odor T hreshold Synonyms Value CH3-(OC3H6)2-OH 148.2 g/mol >98% Water 50 ppm to 3000 ppm have been observed in inhalation studies using rats, mice, rabbits, guinea pigs, and monkeys. Observations included central nervous system (CNS) effects, adaptive hepatic changes, and decreases in body weight gain. In rats exposed to either 0, 40, 200, or 1000 mg/kg-day DPGME via gavage for 4 weeks, tentative salivation (immediately after dosing) and liver effects (increased relative liver weight, centrilobular hypertrophy) was observed in animals exposed to the highest dose. No effects were observed in rats exposed to 200 mg/kg -day. Studies in rats and rabbits showed that DPGME is not teratogenic (two inhalation studies with NOAELs of 300 ppm). The weight of the evidence indicates that DPGME is not genotoxic. Information collected for a structurally similar chemical (PGME) suggests that DPGME is not a reproductive toxicant, and is not carcinogenic. Additionally, no effects were seen on the testes and ovaries in a 28-day repeat dose oral toxicity study on DPGME. In humans, concentrations of 35-75 ppm may be expected to produce irritation to the eyes, nose, throat, and respiratory tract. Therefore, human exposures to concentrations of DPGME greater than 75 ppm are expected to be self-limiting. DPGME is not persistent in the environment and is not expected to bioaccumulate in food webs. The half-life of DPGME in air was measured at 5.3 hours and is estimated to be 3.4 hours due to direct reactions with photochemically generated hydroxyl radicals. DPGME is readily biodegraded under aerobic conditions, but only slightly degraded under anaerobic conditions. Although environmental monitoring data are not available for DPGME, fugacity-based modeling indicates that PGME is likely to partition to water compartments in the environment (surface water, groundwater). Acute toxicity testing in fish, invertebrates and algae indicate a very low order of toxicity with effect concentrations exceeding 1000 mg/L. A PNEC of 19 mg/L was derived by applying an uncertainty factor of 100 to the 48-hour LC50 value of 1919 mg/L for daphnids. Approximately 38 million pounds (17 thousand tons) of DPGME were produced in the U.S. in 1999 (Appendix A). Approximately 12,000 tons of DPGME were consumed in the U.S. in 1995 (Staples and Davis, 2001). Production in the U.S. was estimated at 35 million pounds (16 thousand tons) for 2000 (Chemical Economics Handbook on Glycol Ethers (1996), SRI International). DPGME occurred in 123 products present on the Swedish market in July 1989. DPGME is used in the manufacture of a wide variety of industrial and commercial products, including paints, varnishes, inks, and cleaners. In the US in 1999, DPGME was used as follows: 58% paints/coatings/inks, 28% cleaners, 10% DPGME acetate production and 3% miscellaneous production. Exposures to DPGME are likely to occur for workers and consumers. Inhalation exposures to relatively high concentrations of DPGME are believed to be self-limiting due to the irritant effects of the chemical. Use of protective gloves to minimize absorption is recommended when prolonged dermal exposures to DPGME are anticipated. 18 UNEP PUBLICAIONS OECD SIDS 6.0 DIPROPYLENE GLYCOL METHYL ETHER REFERENCES ACGIH (American Conference of Governmental Industrial Hygienists). (1991). Documentation of Threshold Limit Values and Biological Exposure Indices, 6th Edition. Ballantyne, B. 1983. Local ophthalmic effects of dipropylene glycol monomethyl ether. Toxicol. – Cut. Ocular Toxicol. 2, 229-242. J. Ballantyne, B. 1984a. J. Toxicol. Cutan. Ocul. Toxicol. 3: 7-16. Balantyne, B. 1984b. J. Toxicol. Cutan. Ocul. Toxicol. 2: 229 -242. Bartlett, et al. 1979. Toxicity of DOWANOL DPM to freshwater organisms. Unpublished report The Dow Chemical Company. BASF. 1983. Biodegradation of dipropylene glycol meth yl ether I the Zahn-Wellens test. BASF unpublished report, 4p.. BASF (1988). Spaltung von 2-methoxypropylacetat im rattenplasma (84/73). Unpublished results of BASF AG, Ludwigshafen, Germany Breslin, W.J., et al. 1990. Development toxicity of inhaled dipropylene glycol monomethyl ether (DPGME) in rabbits and rats. Toxicologist 10, p. 39. Browning, E. 1965. Dipropylene glycol monomethyl ether toxicity and metabolism of industrial solvents. Elsevier Publishing Company, Amsterdam, 657-660. BUA. 1995. BUA Reports 173 and 174: Methoxypropanol (propylene glycol methyl ether), Dipropylene glycol ethyl ether. GDCh-Advisory Committee on Existing Chemicals of Environmental Relevance (BUA). Bysshe, S.E. 1990. Bioconcentration factor in aquatic organisms. In: Lyman, W.J. et al. (Ed.): Handbook of chemical property estimation methods. American Chemical Society, Washington DC, 5-1 – 5-30, 31p. Carney EW and Johnson KA (2000). Comparative developmental toxicity of the glycol ether metabolites, methoxyacetic acid and methoxypropionic acid. Teratolgoy 61:53. E.W. Carney, J.W. Crissman, A.B. Liberacki, C.M. Clements, and W.J. Breslin, “Assessment of adult and neonatal reproductive parameters in Sprague-Dawley Rats exposed to Propylene Glycol Monomethyl Ether vapors for two generations," Toxicol.Sci. 50, 249-258 (1999) Chemical Economics Handbook on Glycol Ethers (1996), SRI International Chemical Economics Handbook on Glycol Ethers (2000), SRI International Cieszlak, F.S., et al. 1998a. Propylene Glycol Monomethyl Ether: A 2-year Vapor Inhalation Chronic Toxicity/Oncogenicity Study and Evaluation of Hepatic and Renal Cellular Proliferation, P450 Enzyme Induction and Protein Droplet Nephropathy in Fischer 344 Rats. Unpublished report (in prepar ation) of the Dow Chemical Company (sponsored by the Chemical Manufacturers Association P-Series Glycol Ethers Panel, Arlington, VA). UNEP PUBLICAIONS 19 OECD SIDS DIPROPYLENE GLYCOL METHYL ETHER Cieszlak, F.S., et al. 1998b. Propylene Glycol Monomethyl Ether: A 2-year Vapor Inhalation Chronic Toxicity/Oncogenicity Study and Evaluation of Hepatic Cellular Proliferation in B6C3F1 Mice. Unpublished report (in preparation) of the Dow Chemical Company (sponsored by the Chemical Manufacturers Association P-Series Glycol Ethers Panel, Arlington, VA). Clayton, G.D. and Clayton, F.E. (eds). 1982. Patty’s Industrial Hygiene and Toxicology, 3r d Edition, Volume 2C. John Wiley & Sons, New York. Clayton, G.D. and Clayton, F.E. (eds). 1994. Patty’s Industrial Hygiene and Toxocology, 4th Edition, Volume 2C. John Wiley & Sons, New York. Cullen, M.R. et al. 1983. Bone marrow injury in lithographers exposed to glycol ethers and organic solvents… Arch. Environ. Health 38, 347-354. DOW. 1951. Results of the skin irritation and skin sensitization tests conducted on human subjects with DOWANOL 50B. Unpublished report of the DOW Chemical Company, 6p. DOW. 1975. Photodecomposition of Dowanol glycol ethers. Chemical Company, 33p. Unpublished report of DOW DOW Europe S.A. 1990a. Assessment of the inherent biodegradability of DOWANOL DPM in the Modified Strum Test using pre-adapted inoculum. Unpublished report of Dow Europe SA. DOW Chemical Company. 1990b. Assessment of the inherent biodegradability of DOWANOL*DPM in the Modified Sturm Test using pre-adapted inoculum. Unpublished report of DOW Europe S.A., 10p. DOW Chemical Company. 1992. Material Safety Data Sheet, DOW Europe S.A. March, 1992. DOW Chemical Company Report DET-2255. 1995. Daphnia magna reproduction study on DOWANOL DPM. Unpublished report of The Dow C hemical Company. DOW Chemical Japan. Unpublished Report # 0006P (2000). partition coefficient of DPM, July 14, 2000. Final report: 1-octanol/water Dow Chemical Japan. Unpublished Report # S -0001 (2000). Final report: Stability of DPM. June 20, 2000. Dow Chemical U.S. Unpublished Report #971174 (1998). Evaluation of the anaerobic biodegradation of 1-methoxy-2-propanol (Dowanol*PM) and dipropylene glycol monomethyl ether (Dowanol*DPM) in anaerobic digester sludge. January 30, 1998. Dow Chemical Japan. Unpublished Report #FBM 00-8027 (2000). Final report: chromosomal aberration test in cultured mammalian cells. May 31, 2000. DPM: Dow Chemical Japan. Unpublished Report #FBM 00 -8026 (2000). Final report: DPM: bacterial reverse mutation assay. May 31, 2000. Dow Chemical Japan. Unpublished Report #FBM 99-2691 (2000). Final report: Oral repeateddose-4-week toxicity study of DPM in rats with 2-week recovery study. July 3, 2000. Dugard et al. 1994. Absorption of some glycol ethers through human skin in vitro. Environmental Health Perspectives. 57: 193 -197. ECOL Database: Numerical Index. 1986. Unpublished report of the Dow Chemical Company. 20 UNEP PUBLICAIONS OECD SIDS DIPROPYLENE GLYCOL METHYL ETHER EBRC. 1994. Naeherungsweise Berechnung der Mackay Verteilung fuer DPGME. Schriftliche Mitteilung vom 15.07.1994, Dr. R.V. Battersby, EBRC GmgH, Hannover, 7p. EBRC. 1995a. Berechnung des Verteilungskoeffizienten fr n-Oktanol/Wasser (logPow)feur DPGME. Schriftliche Mitteilung vom 18.01.1995, Dr. R.V. Battersby, EBRC Consulting GmbH, Hannover , 5p. EBRC. 1995c. Berechnung der Henry -Konstante von DPGME. Schriftliche Mitteilung vom 18.01.1995, Dr. R.V. Battersby, EBRC Consulting GmbH, Hannover, 4p. Chemical Economics Handbook on Glycol Ethers (1996), SRI International ECTOC. 1985. The tox icology of glycol ethers and its relevance to man: ECETOX Technical Report No. 4, 66p. An up-dating of Elias, Z., et al. 1996. Occupational Hygiene 2:187-212. Fairhurst, S. et al. 1989. Percutaneous toxicity of ethylene glycol monomethyl ether and of dipropylene glycol monomethyl ether in the rat. Toxicol. 57, 209-216. Hansen, M.K, et al. 1987. Waterborne paints. Scand. J. Work. Environ. Health 13, 473 -485. Hart, D. 1991. Report on the phytotoxicity of DOWANOL DPM following foliar spray application. Unpublished report of Dow Europe S.A. Hellwig J, Klimisch HJ, Jäckh R (1994). Prenatal toxicology of inhalation exposure to 2-methoxypropanol in rabbits. Fund Appl. Toxicol. 23, 608-613. HSDB. 1993. Dipropylene glycol monomethylether, HSDB-Database, Search from 27.1.1993. Kirk HD, Gilles MM, McClymont EL, McFadden LG. 2000. Dipropylene glycol methyl ether (DPGME): growth inhibition test with the freshwater green alga, Selenastrum capricornum PRINTZ. Unpublished Dow Chemical study, #001212. Kirkland, D.Y. 1983. Metaphase analysis of Chinese Hamster Ovary cells treated with DOWANOL DPM. Unpublished report of Dow Chemical Europe. Kirkland, D.Y. and Varley, R. 1983. Bacterial mutagenicity test on DOWANOL DPM. Unpublished report of The Dow Chemical Company. Landry, T.D. et al. 1981. DOWANOL DPM: A 2 week inhalation toxicity study in rats and mice. Unpublished report of the Dow Chemical Company, 45p. Landry, T.D., et al. 1983. Fund Appl Toxicol. 3:627-630. Landry, T.D. and Yano, B.L. 1984. Dipropylene glycol monomethyl ether: inhalation toxicity study in rats and rabbits. Fundam. Appl. Toxicol. 4, 612-617. A 13 week Mackay, D. Multimedia Environmental Models; The Fugacity Approach. Lewis Publ., CRC Press, Boca Raton, FL. 1991. Mackay, D. and Paterson, S. 1991. Environmental Science & Technology. 25:427 -436 UNEP PUBLICAIONS 21 OECD SIDS DIPROPYLENE GLYCOL METHYL ETHER Mendrala, A.L. 1983. Evaluation of DOWANOL* PM in the Rat Hepatocyte Unscheduled DNA Synthesis Assay. Unpublished report of the Dow Chemical Company. Mendrela AL, Markley BJ, Verschuuren HG, McNett DA, Reitz RH (1993). Pharmacokinetics of dipropylene glycol dimethyl ether in rats. Unpublished report of the DOW Chemical Company, Midland MI USA. Miller, R.R., et al. 1985. Metabolism and disposition of dipropylene glycol monomethyl ether (DPGME) in male rats. Fund. Appl. Toxicol. 5, 721 -726. Miller RR, Langvardt PW, Calhoun LL, Yahrmarkt MA (1986). Metabolism and disposition of propylene glycol monomethyl ether (PGME) beta isomer in male rats. Toxicol. Appl. Pharmacol. 67, 229-237. Pomona College. 1989. Dipropylene glycol methyl ether (Dowanol DPM), Medicinal Chemistry, Pomona College Database, 1p. Pottenger LH, Bus JS, McNett DA (1995). In vitro metabolism of propylene glycol ethers. Unpublished report of the DOW Chemical Company, Midland MI USA. Prehled Prumyslov Toxikol. Org. Latky. 1986. 1986:633. Rowe V.K., et al. 1954. Arch Ind. Hyg. Occup. Med. 9:509 -525. Shideman, F.E. and L. Puscita. 1951. J. Pharmacol. Exp. Therap. 102:79-87. Smyth, H.F., et al. 1962. Amer. Ind. Hyg. Assoc. J. 23:95-107. Staples CA, Davis JW. 2001. An environmental risk assessment of propylene glycol ethers. (in prep). Stenger, V.E.G., et al. 1972. Arzeim Forsch 22:569-574. Thomas, R.G. 1990. Volatilization from water. In: Lyman, W.J. et al. (ED.): Handbook of chemical property estimation methods. American Chemical Society, Washington DC, 15 -115-7, 35p. Union Carbide Data Sheet. 1971. Union Carbide Company, 11/15/71. 22 UNEP PUBLICAIONS OECD SIDS DIPROPYLENE GLYCOL METHYL ETHER Appendix A. Production and Use Information DPGME Dipropylene glycol methyl ether 34590-94-8 (mixture) Isomer CAS #s 20324-32-7 (40 -45%) 13429-07-7 (40 -50%) 13588-28-8 (2-5%) 55956-21-3 (3-5%) *1999 Production Volume Types of Commercial End Products United States 38 million pounds (17 thousand tons) Paints, coatings and inks 58% 2-20% Cleaners 28% 2-25% DPGMEA 10% **Misc. 3% US Percent Production Industrial/ In Product Commercia Types l Approx Percentage Weight Use if Fraction Known *Chemical Economics Handbook, SRI International 2000. Data not reported for DPGME for other countries. **Floor polishes, cosmetics, solvents DPGME is a mixture of four isomers. According to the manufacturers specification, (BUA Reports 173 and 174: Methoxypropanol (propylene glycol meth yl ether), Dipropylene glycol ethyl ether. GDCh-Advisory Committee on Existing Chemicals of Environmental Relevance), the respective fractions of the structural isomers are 40-50% 1-(2-methoxypropoxy)propanol-2 (CASRN: 13429-07-7), 40-45% 1-(2-methoxy-1-methylethoxy)propanol-1 (CASRN: 20324-32-7), 2-5% 2-(2-methoxypropoxy)propanol-1 (CASRN: 13588-28-8), and 3-5% 2-(2-methoxy -1methylethoxy)propanol-1 (CASRN: 55956-21-3). Commercial DPGME is produced only as a four-isomer mixture and hence all testing was conducted on the commercial mixture. The four individual isomers are not separated nor produced as individual chemicals. 1-(2-methoxy -1methylethoxy) propanol-1 (CASRN: 20324-32-7), was listed erroneously as an HPV chemical due to incorrect reporting of t he CAS # on the 1990 IUR. UNEP PUBLICAIONS 23 OECD SIDS DIPROPYLENE GLYCOL METHYL ETHER Appendix B. Quantitative Evaluation of Potential Exposures to DPGME B.1 Predicted Environmental Concentration (PEC) A fugacity-based, multimedia model (Level 3) was run for DPGME (Staples and Davis, 2001). Based on an estimate of 12,000 tonnes of DPGME were consumed in the U.S. during 1995, source terms for release to air, water, and soil were calculated to be 122, 13.7, and 1.4 kg/hour, respectively. Model predictions for the concentrations of DPGME in four environmental compartments were as follows: − − − − Air: 9.24 ng/m 3 Water: 0.053 ug/L Soil: 0.28 ug/kg Sediment: 0.030 ug/kg B.2 Quantitative Assessment of Human Exposures Assessment of Occupational Exposures Exposure to DPGME in the occupational setting can occur through inhalation or dermal exposure. • Inhalation Exposure - Estimated human exposures (EHE) ranging 30 to 40 mg/m 3 are considered to conservatively representative of potential occupational exposures. • Dermal Exposure - EHEs ranging from 0.48 mg/kg -d to 22.7 m g/kg-d were calculated using the following equation based on U.S. Environmental Protection Agency (USEPA) guidance (1989): Dermal Dose = % PGME * ET * EF * ED * SA * AR AT * BW Where, Dermal Dose %PGME ET EF ED SA = = = = = = AR AT BW = = = average daily dermal dose (mg/kg-day); percent DPGME in product contacted by w orker (10% and 50% assumed); exposure time (1 and 2 hours/day assumed); exposure frequency (125 and 250 days/year assumed); exposure duration (25 years as an upperbound for occupational tenure (EFH, 1996)); surface area of exposed skin (840 cm2 for hands only; 1980 cm2 for hands and forearms (EFH, 1996)); absorption rate (1.17 mg/cm2/hr for PGME (data for DPGME not available) (Dugard et al. 1984)); averaging time (9125 days based on ED assumption); body weight (70 kg (USEPA, 1989). Assessment of Consumer Exposures Consumers may be exposed to DPGME through inhalation and dermal contact. • 24 Inhalation Exposure – EHEs ranging from 30 mg/m 3 to 40 mg/m3 are considered to be conservatively representative of potential consumer exposures. UNEP PUBLICAIONS OECD SIDS • DIPROPYLENE GLYCOL METHYL ETHER Dermal Exposure - EHEs ranging from 0.005 mg/kg-d to 0.45 mg/kg-d were calculated using the following equation based on USEPA (1989) guidance: Dermal Dose = Where, Dermal Dose %DPGME = = ET EF ED SA = = = = AR = AT = %PGME * ET * EF * ED * SA * AR AT * BW average daily dermal dose (mg/kg-day); percent DPGME in product contacted by consumer (1 and 10% assumed); exposure time (0.5 and 1 hours/day assumed); exposure frequency (25 and 50 days/years assumed); exposure duration (30 years); surface area of exposed skin (840 cm2 for hands only (EFH, 1996); 1980 cm2 for hands and forearms (EFH, 1996)); absorption rate (1.17 mg/cm2/hr for PGME (DPGMEe data not available) (Dugard et al. 1984)); averaging time (10,950 days based on ED assumed); BW = body weight (70 kg). Assessment of Indirect Exposures via the Environment Although monitoring data are not available, concentrations of DPGME in water have been estimated using fugacity-based modeling. Theoretical oral doses were calculated using the equation given below: Oral Dose = Where, C = IR EF ED AT BW = = = = = C * IR * EF * ED AT * BW concentration of DPGME in media (air: 0.00000924 mg/m3; water: 0.000053 mg/L; soil: 0.00028 mg/kg); intake rate for media (air: 20 m3/day; water: 2 L/day; soil: 0.0001 kg/day); exposure frequency (350 days/year); exposure duration (30 years); averaging time (10950 days ); and body weight (70 kg). Based on these assumptions, doses of 0.0000025, 0.0000015, 0.00000000038 mg/kg-day were calculated for human exposures to DPGME in air, water, and soil, respectively. UNEP PUBLICAIONS 25 OECD SIDS DIPROPYLENE GLYCOL METHYL ETHER SIDS DOSSIER DIPROPYLENE GLYCOL METHYL ETHER CAS No. 34590-94-8 (Isomers: 13429-07-7, 20324-32-7; 13588-28-8; and 55956-21-3) Sponsor Country: U.S.A. DATE: March 2001 Updated November 2001 26 UNEP PUBLICATIONS OECD SIDS DIPROPYLENE GLYCOL METHYL ETHER CONTENTS SIDS PROFILE SIDS SUMMARY 1. 1.01 1.02 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 1.10 GENERAL INFORMATION SUBSTANCE INFORMATION A. CAS-NUMBER B. NAME (IUPAC -NAME) C. NAME (OECD NAME) D. CAS DESCRIPTOR E. EINECS -NUMBER F. MOLECULAR FORMULA G. STRUCTURAL FORMULA H. SUBSTANCE GROUP I. SUBSTANCE REMARK J. MOLECULAR WEIGHT OECD INFORMATION A. SPONSOR COUNTRY B. LEAD ORGANISATION C. NAME OF RESPONDER (COMPANY) GENERAL SUBSTANCE INFORMATION A. TYPE OF SUBSTANCE B. PHYSICAL STATE C. PURITY SYNONYMS IMPURITIES ADDITIVES QUANTITY LABELLING AND CLASSIFICATION (USE AND/OR TRANSPORTATION) USE PATTERN A. GENERAL USE PATTERN B. USES IN CONSUMER PRODUCTS OCCUPATIONAL EXPOSURE LIMIT VALUE SOURCES OF EXPOSURE ADDITIONAL REMARKS A. OPTIONS OF DISPOSAL B. OTHER REMARKS. 2. PHYSICAL -CHEMICAL DATA 2.1 2.2 2.3 2.4 2.5 2.6 MELTING POINT BOILING POINT DENSITY (RELATIVE DENSITY) VAPOUR PRESSURE PARTITION COEFFICIENT n-OCTANOL/WATER WATER SOLUBILITY A. SOLUBILITY B. pH VALUE, pKa VALUE FLASH POINT (LIQUIDS) AUTO FLAMMABILITY (SOLID/GASES) FLAMMABILITY 2.7 2.8 2.9 UNEP PUBLICATIONS 27 OECD SIDS 2.10 2.11 2.12 2.13 3. 3.1 3.1.1 3.1.2 3.1.3 3.2 3.3 3.3.1 3.3.2 3.4 3.5 3.6 3.7 3.8 DIPROPYLENE GLYCOL METHYL ETHER EXPLOSIVE PROPERTIES OXIDIZING PROPERTIES OXIDATION:REDUCTION POTENTIAL ADDITIONAL REMARKS A. PARTITION CO-EFFICIENT BETWEEN SOIL/SEDIMENT AND WATER (Kd) B. OTHER REMARKS ENVIRONMENTAL FATE AND PATHWAYS STABILITY PHOTODEGRADATION STABILITY IN WATER STABILITY IN SOIL MONITORING DATA (ENVIRONMENT) TRANSPORT AND DISTRIBUTION BETWEEN ENVIRONMENTAL COMPARTMENTS INCLUDING ESTIMATED ENVIRONMENTAL CONCENTRATIONS AND DISTRIBUTION PATHWAYS TRANSPORT THEORETICAL DISTRIBUTION (FUGACITY CALCULATION) MODE OF DEGRADATION IN ACTUAL USE BIODEGRADATION BOD-5, COD OR RATIO BOD-5/COD BIOACCUMULATION ADDITIONAL REMARKS A. SEWAGE TREATMENT B. OTHER 4. ECOTOXICITY 4.1 4.2 4.7 4.8 4.9 ACUTE/PROLONGED TOXICITY TO FISH ACUTE TOXICITY TO AQUATIC INVERTEBRATES A. DAPHNIA B. OTHER AQUATIC ORGANISMS TOXICITY TO AQUATIC PLANTS e.g., ALGAE TOXICITY TO BACTERIA CHRONIC TOXICITY TO AQUATIC ORGANISMS CHRONIC TOXICITY TO FISH CHRONIC TOXICITY TO AQUATIC INVERTEBRATES (e.g., DAPHNIA REPRODUCTION) TOXICITY TO TERRESTRIAL ORGANISMS TOXICITY TO SOIL DWELLING ORGANISMS TOXICITY TO TERRESTRIAL PLANTS TOXICITY TO OTHER NON-MAMMALIAN TERRESTRIAL SPECIES (INCLUDING BIRDS) BIOLOGICAL EFFECTS MONITORING (INCLUDING BIOMAGNIFICATION) BIOTRANSFORMATION AND KINETICS ADDITIONAL REMARKS 5. TOXICITY 5.1 5.1.1 5.1.2 5.1.3 5.1.4 5.2 ACUTE TOXICITY ACUTE ORAL TOXICITY ACUTE INHALATION TOXICITY ACUTE DERMAL TOXICITY ACUTE TOXICITY BY OTHER ROUTES OF ADMINISTRATION CORROSIVENESS/IRRITATION 4.3 4.4 4.5 4.5.1 4.5.2 4.6 4.6.1 4.6.2 4.6.3 28 UNEP PUBLICATIONS OECD SIDS 5.2.1 5.2.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10 5.11 6. Note: DIPROPYLENE GLYCOL METHYL ETHER SKIN IRRITATION/CORROSION EYE IRRITATION/CORROSION SKIN SENSITISATION REPEATED DOSE TOXICITY GENETIC TOXICITY IN VITRO A. BACTERIAL TEST B. NON-BACTERIAL IN VITRO TEST GENETIC TOXICITY IN VIVO CARCINOGENICITY TOXICITY TO REPRODUCTION DEVELOPMENTAL TOXICITY / TERATOGENICITY OTHER RELEVANT INFORMATION A. SPECIFIC TOXICITIES (NEUROTOXICITY, IMMUNOTOXICITY etc.) B. TOXICODYNAMICS, TOXICOKINETICS EXPERIENCE WITH HUMAN EXPOSURE REFERENCES Data elements in the SIDS Data elements specially required for inorganic chemicals UNEP PUBLICATIONS 29 OECD SIDS DIPROPYLENE GLYCOL METHYL ETHER SIDS PROFILE DATE: March 2001 1.01 A. CAS No. 34590-94-8 (isomers: 13429-07-7, 20324-32-7; 13588-28-8; and 55956-21-3) 1.01 C. CHEMICAL NAME (OECD Name) 2-Methoxymethylethoxy-propanol 1.01 D. CAS DESCRIPTOR Not applicable in this case. 1.01 G. STRUCTURAL FORMULA CH3-(OC3H6)2-OH OTHER CHEMICAL IDENTITY INFORMATION Mixture of 4 isomers. 1.5 QUANTITY In FRG approx 19,500 tonnes in 1994. In US 38 million pounds (17 thousand tons) in 1999. 1.7 (a) Wide dispersive use in domestic, commercial and industrial cleaners. USE PATTERN (b) Wide dispersive use in formulation of inks, paints, coatings, and cleaners. 1.9 SOURCES AND LEVELS OF EXPOSURE 1. Accumulation of DPGME in air of closed rooms during use of water-based paints was measured at 30-40 mg/m3 or approximately 10% of the 8 hr TWA of 308 mg/m3. 2. Exposures to DPGME as a solvent component in screen printing inks have been documented to be as high as 22 mg/m3 in the absence of local exhaust ventilation. ISSUES FOR DISCUSSION (IDENTIFY, IF ANY) 30 UNEP PUBLICATIONS ? Y N Y Y Y Y Y Y N Y Y Y Y N Y N ECOTOXICITY 4.1 Acute Toxicity to Fish 4.2 Acute Toxicity to Daphnia 4.3 Toxicity to Algae 4.5.2 Chronic Toxicity to Daphnia 4.6.1 Toxicity to Soil Dwelling Organisms 4.6.2 Toxicity to Terrestrial Plants 4.6.3 Toxicity to Birds Y Y UNEP PUBLICATIONS ? ? Y Y N N Y Y ? ? ? ? Y ? N N N N Y N GLP Y/N Y Y Y Y Y Y N N N Info OECD Available Study Y/N Y/N SIDS SUMMARY Date: January 1999 Study PHYSICAL CHEMICAL DATA 2.1 Melting Point 2.2 Boiling Point 2.3 Density 2.4 Vapor Pressure 2.5 Partition Coefficient 2.6. Water Solubility pH and PkA values 2.12 Oxidation Reduction Potential OTHER P/C STUDIES RECEIVED ENVIRONMENTAL FATE and PATHWAYS 3.1.1 Photodegradation 3.1.2 Stability in water 3.2 Monitoring data 3.3 Transport and Distribution 3. 5 Biodegradation OTHER ENVI FATE STUDIES RECEIVED CAS No: 34590-94-8 OECD SIDS Y Y Y Y Y Y Y Y Y N Y Other Study Y/N N N N N Y N N N N N N Y Y Y Y Y Y Y Y Y Y Y Estimation Testing Method Acceptable Required Y/N Y/N Y/N 31 DIPROPYLENE GLYCOL METHYL ETHER 32 Study TOXICITY 5.1.1 Acute Oral 5.1.2 Acute Inhalation 5.1.3 Acute Dermal 5.4 Repeated Dose 5.5 Genetic Toxicity in vitro -Gene Mutation -Chromosome Aberration 5.6 Genetic Toxicity in vivo 5.8 Reproduction Toxicity 5.9 Development/Teratogenicity 5.11 Human Experience OTHER TOXICITY STUDIES RECEIVED CAS No: 34590-94-8 OECD SIDS N N N Y Y Y Y N N N N N Y Y N N Y Y Y Y