Phthalates Profile

INDUSTRIAL CHEMICALS  POSSIBLE CARCINOGEN (IARC 2B)

CAS No. 117-81-7
IARC Monograph Vol. 77, 2000 and Vol. 101, 2013 (Group 2B)

Phthalates Profile

General Information

Di(2-ethylhexyl) phthalate (DEHP) is a colourless, oily liquid with a faint odour.[1,2] Widely used as a plasticizer in flexible plastics, DEHP may also be referred to as bis(2-ethylhexyl) phthalate and phthalic acid. There are numerous other synonyms and product names; see HSDB for more information.[3]

DEHP was re-evaluated by the International Agency for Research on Cancer (IARC) in 2011, when it was upgraded from Group 3 to Group 2B, possibly carcinogenic to humans.[4] In animal studies, DEHP exposure resulted in increased incidences of hepatocellular adenomas and carcinomas in rats and mice.[1] Other reported effects related to exposure include pancreatic adenomas and carcinomas in male rats, as well as testicular leydig-cell tumours in rats.[4] Information on human carcinogenicity of DEHP was limited; at the time of the Monograph, only one study reported no increased cancer mortality in a small number of DEHP production workers.[1]

Additionally, DEHP is a skin, eye, and respiratory tract irritant.[3]

Regulations and Guidelines

Occupational Exposure Limits (OEL)[5,6,7,8,9,10,11,12,13,14,15,16,17,18,19]

Canadian Jurisdictions OEL (mg/m3)
Canada Labour Code 5
AB, BC, MB, NB, NL, NS, PE 5
ON 3
5 [stel]
SK, QC, YK, NU, NT 5
10 [stel]
Other Organizations OEL (mg/m3)
ACGIH 2018 TLV 5
mg/m3 = milligrams per cubic metre
stel = short term exposure limit (15 min. maximum)
ACGIH = American Conference of Governmental Industrial Hygienists
TLV = threshold limit value (8 hour maximum)

Canadian Environmental Guidelines

Jurisdiction Limit Year
Ontario Ambient Air Quality Criteria 24 hours: 50 μg/m3 2016[20]
Agreement Respecting the Great Lakes Basin Ecosystem Concentration in water should not exceed 0.6 μg/L for the protection of aquatic life 1987[21]
BC’s Contaminated Sites Regulation, BC Reg 375/96 Sets soil standards for the protection of human health:
Agricultural and low density residential sites: 150 μg/g
Urban park and high density residential sites: 350 μg/g
Commercial sites: 1,000 μg/g
Industrial sites: 30,000 μg/g

 

Drinking water: 10 µg/L

2017[22]
Cosmetic Ingredient Hotlist Prohibited for use 2015[23]
Canada Consumer Product Safety Act – Phthalates Regulations Limits DEHP concentrations in all soft vinyl children’s toys and childcare articles to 1,000 mg/kg 2016[24]
μg/m3 = micrograms per cubic metre
μg/L = micrograms per litre
μg/g = micrograms per gram
DEHP was not included in any other Canadian environmental guidelines reviewed.[25,26,27,28,29,30]

Canadian Agencies/Organizations

Agency Designation/Position Year
Health Canada DSL – low priority substance, already risk managed 2006[31]
CEPA (Schedule 1) Paragraph ‘C’ (Human Health) 2010[32]
National Classification System for Contaminated Sites Rank = “High hazard” 2008[33]
Environment Canada’s National Pollutant Release Inventory NPRI Part (Threshold Category): 1A, Reportable to NPRI if manufactured, processed, or otherwise used at quantities greater than: 10 tonnes 2016[34]
DSL = domestic substances list
CEPA = Canadian Environmental Protection Act
DEHP was not included in the Government of Canada’s Chemicals Management Plan.[35]

Main Uses

Di(2-ethylhexyl) phthalate is the most important phthalate plasticizer used in Canada.[32] It is almost exclusively (>95%) used to manufacture flexible polyvinyl chloride (PVC) plastics.[2,36] PVC plastics containing DEHP are used to produce a wide range of products including flooring, food packaging, imitation leather, rainwear, footwear, upholstery, wire and cable, tablecloths, shower curtains, soft squeeze toys, balls, blood storage bags, medical tubing, and gloves.[4,37] Depending on the desired properties of the plastic, PVC plastics may contain 1-40% DEHP by weight.[2,4]

Other materials that also include DEHP for its plasticizing properties include polyvinyl butyral, natural and synthetic rubber, chlorinated rubber, ethyl cellulose, and nitrocellulose.[36]

Non-plasticizer applications of DEHP include use in dielectric fluids for capacitors, in vacuum pump oil, as an acaricide (a pesticide used to kill ticks and mites) in orchards, as a solvent in erasable ink, as an ingredient in printing inks for food wrappers, as an inert ingredient for pesticides, and in testing of respirators and air filtration systems.[2,4,36]

Canadian Production and Trade

As of 2016, DEHP was produced by Polyone Canada, however their website indicates that they currently sell a wide variety of non-phthalate alternatives as well.[38]

Production and Trade

Activity Quantity Year
Export 140 t of ‘Dioctyl orthophthalates’ 2015[39]
Import 1,464 t of ‘Dioctyl orthophthalates’ 2015[39]
t = tonne

Environmental Exposures Overview

Because of its widespread use in consumer products, most individuals in the general public are exposed to measurable amounts of DEHP.[1,2,36] Although there is widespread concern about DEHP levels in bottled water, exposure mostly occurs by ingesting contaminated food and administering contaminated intravenous fluids during medical procedures.[2,40]

Detectable amounts of DEHP are found in various food products as a result of bioaccumulation and/or leaching from food packaging materials.[37] Higher levels of DEHP have been found in products with high fat content, such as meat, fish, eggs, and milk products.[2,40]

A significant source of exposure to DEHP is leaching from flexible plastic tubing and bags used in medical devices; this is especially the case for individuals who require regular intravenous treatments such as dialysis.[1,2,37] DEHP concentrations in products stored in these medical devices can be three to six orders of magnitude higher than DEHP concentrations in water and food. As with food, higher levels of DEHP have been found in products with higher fat content.[40]

Infant and children’s soft toys and soft plastic products formerly contained high levels of DEHP (up to 31 – 42% by weight). However, recent reduction and proposed elimination of DEHP in these products will greatly reduce ingestion exposure via children’s toys and products.[36] In 2011, the Government of Canada passed a new regulation, further limiting the amount of allowable DEHP in children’s products to 1,000 mg/kg (0.1%). [41]

DEHP is detected almost ubiquitously in air and water samples.[1,2] However, due to its low volatility and low solubility in water, DEHP concentrations in air and water are generally very low.[36] Ambient exposure for an average adult is estimated at between 0.21 – 2.1 mg/day.[36] DEHP concentrations in indoor air, which are the result of off-gassing from consumer products and building materials, tend to be higher than in outdoor ambient air.[2]

The US Household Products Database listed one lacquer product as having DEHP as an ingredient.[42] Searches of Environment Canada’s National Pollutant Release Inventory (NPRI) database yielded the following results for DEHP release in Canada:

Occupational Exposures Overview

Occupational exposure to DEHP occurs by inhalation of its aerosol or mist form, which is a result of its very low vapour pressure.[1,2]

Occupational exposure to DEHP occurs primarily among workers involved in manufacturing and processing DEHP and flexible PVC plastics.[1,2] High levels of exposure may occur while formulating and compounding DEHP in PVC manufacturing.[36] Printing and painting occupations also account for a large number of workers potentially exposed to DEHP.[4]

Few data are available on levels of occupational exposure to DEHP.[4] Concentrations in air were reported to be as high as 60 mg/m3 in older studies, however, these studies reported concentrations of total phthalates.[4] Several studies showed that urinary levels of DEHP, its metabolites, and total phthalates were higher in DEHP-exposed workers compared to unexposed workers, and in post-shift samples compared to pre-shift samples.[4]

CAREX Canada has not prioritized phthalates for exposure estimate development. This is because there is a lack of exposure monitoring data in the Canadian Workplace Exposure Database on which to base an estimate.

Sources

1. International Agency for Cancer on Research (IARC). IARC monograph summary, Volume 77 (2000) (PDF)
2. National Toxicology Profile (NTP). 14th Report on Carcinogens for di(2-Ethylhexyl) Phthalate (2016) (PDF)
3. US National Library of Medicine. Hazardous Substances Data Bank (Search term: ‘Bis(2-ethylhexyl) phthalate’)
4. International Agency for Research on Cancer (IARC). Monograph summary, Volume 101 (2011) (PDF)
10. Government of Newfoundland and Labrador. Regulation 5,12 Occupational Health and Safety Regulations (2012)
11. Government of the Northwest Territories. Occupational Health and Safety Regulations, R-039-2015 (2016) (PDF)
13. The Canadian Legal Information Institute (CanLII). Government of Nunavut’s Occupational Health and Safety Regulations, Nu Reg 003-2016 (2010)
15. Government of Prince Edward Island. Occupational Health and Safety Act Regulations Chapter 0-1 (2013) (PDF)
17. Government of Saskatchewan. The Occupational Health and Safety Regulations, 1996 (2016) (PDF)
18. The Canadian Legal Information Institute (CanLII). Yukon’s Occupational Health Regulations, O.I.C. 1986/164 (2012) (PDF)
19. Occupational Safety and Health Administration (OSHA). Annotated PELs (2018)
20. Ontario Ministry of the Environment and Climate Change. Ontario’s Ambient Air Quality Criteria (2016)
21. International Joint Commission. Revised Great Lakes Water Quality Agreement of 1978 (1978) (PDF)
22. Government of British Columbia. Contaminated Sites Regulation B.C. Reg. 375/96 (2017)
24. Government of Canada. Phthalates Regulations, SOR/2016-188 (2016)
28. The Canadian Legal Information Institute (CanLII). Ontario Drinking Water Quality Standards, O Reg 169/03 (2017)
29. The Canadian Legal Information Institute (CanLII). Regulation respecting the quality of drinking water, CQLR c Q-2, r 40 (2014)
30. Alberta Environment and Parks. Ambient Air Quality Objectives (2017)
32. Environment and Climate Change Canada. Bis (2-ethylhexyl) Phthalate (1994)
33. Canadian Council of Ministers of the Environment (CCME). National Classification System for Contaminated Sites (2008) (PDF)
36. Agency for Toxic Substances and Disease Registry (ATSDR). Toxicological Profile for Di (2-ethylhexyl) Phthalate (2002) (PDF)
37. Agency for Toxic Substances and Disease Registry (ATSDR). Toxicological Profile and Public Health Statement for Di (2-ethylhexyl) Phthalate (DEHP) (2002)
38. PolyOne Canada. General Information (2011)
39. International Trade Centre. TradeMap (Free subscription required)
40. Erythropel HC, Maric M, Nicell JA, Leask RL, Yargeau V.“Leaching of the plasticizer di(2-ethylhexyl)phthalate (DEHP) from plastic containers and the question of human exposure”.Appl Microbiol Biotechnol 2014; 98(24):9967-9981.
42. US Household Products Database (HPD). Household Products (Search term: ‘Phthalates’)

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