October 2013

PHTHALATES Softening plastics & making vinyl pliant for products in our homes, hospitals, cars & businesses

Speakers

Greg Jackson – Senior Product Development Engineer, Axiall Corporation

Dr. Raymond David – Manager, of Toxicology for Industrial Chemicals, BASF

Corporation

Unique Benefits of Phthalates

Phthalates make up 90 percent of the plasticizer market.

Colorless, odorless phthalates are not only cost effective, but

also highly suitable for many flexible vinyl products.

Some of their key characteristics include: durability, flexibility,

weather resistance and ability to withstand high temperatures.

With a wide range of physical and chemical properties,

phthalates are used in a multitude of consumer and industrial

products that demand high performance, long-lasting wear and

durability.

Unique Benefits of Phthalates

While they can be used in a variety of applications, phthalates

are not necessarily interchangeable.

The characteristics of an individual phthalate often make it

well suited to a specific product, allowing manufacturers to

meet unique requirements for its use (function and safety

specifications), appearance (texture, color, size and shape) and

durability and wear.

For this reason, substitutions could impact the functionality,

quality, longevity, cost or performance of a product.

Flexible, Durable, Resistant Products

Building and Construction: From energy-efficient roofing, to flexible adhesives and

sealants, to durable interior finishes, phthalates are used in building and construction

products to make materials and surfaces last longer and easier to maintain. Major uses

of flexible PVC in buildings include: vinyl roofing membranes, resilient flooring, wall

coverings, acoustical ceiling surfaces, waterproofing membranes, and electrical cord

insulation.

Wire and Cable: Durability, low volatility, heat resistance and electrical resistivity

make phthalates a material of choice for protecting wires that run through homes and

offices to charge computers, appliances and electronics. Wires and cables sheathed

with PVC help prevent potentially dangerous electrical accidents.

Automotive: Interiors, vinyl seat covers and interior trim in automobiles use

phthalates because of their ability to withstand high temperatures. PVC coatings and

components in cars help prevent corrosion from water and weather elements. Flexible

vinyl is also used in cars and trucks to make them lighter and more fuel efficient.

Flexible, Durable, Resistant Products

Outdoor Products: Because phthalates help make PVC resistant to changing weather

conditions – maintaining flexibility in cold conditions and resisting degradation in high

temperatures – they are used in many outside products, including: swimming pool

liners, garden hoses, waterproofing for roofs and footwear, like rain boots.

Medical: In hospitals around the world, phthalates help make PVC medical tubing

flexible so it doesn’t break or kink, allowing fluids and medicines to be delivered to

patients at the proper dosage. PVC also allows the internal diameter of medical tubes

to remain constant, which is important in dialysis and other treatments where tubing is

put through devices that apply pressure. And flexible PVC also is used in hospital

flooring because it is affordable, durable and easy to clean, helping to meet sterility

and safety standards.

Safety Information

Phthalates have been reviewed by numerous scientific panels, and the

conclusions have been essentially the same each time: the phthalates used in

commercial products do not pose a risk to human health at typical exposure

levels. Information collected by the Centers for Disease Control and

Prevention (CDC) over the last 10 years indicates that, despite the fact that

phthalates are used in many products, exposure is extremely low – much

lower than the levels considered safe by regulatory agencies.

Background

Regulatory Reviews

• Phthalates are some of the most tested substances in commerce and have been reviewed by a variety of regulatory scientific bodies worldwide, including the U.S. Consumer Product Safety Commission (CPSC), the European Union Chemicals Bureau and the Australian National Industrial Chemicals Notification and Assessment Scheme in the Department of Health and Ageing, the Australian Government regulator of industrial chemicals.

• The U.S. National Toxicology Program’s Center for the Evaluation of Risks to Human Reproduction concluded that there was “minimal concern” regarding risk of developmental or reproductive effects from current exposure levels to DINP, that there was “minimal concern” regarding risk of developmental effects and “negligible concern” regarding risk of reproductive effects from current exposure levels to DIDP.

• The CPSC CHAP on DINP in 2001 and the CPSC staff in 2002 both concluded that exposure to DINP from mouthing soft plastic toys would be expected to pose a minimal to non-existent risk of injury for the majority of children.

Background

The Consumer Product Safety Improvement Act (CPSIA) of 2008

• Imposed restrictions on particular phthalates in certain toys and childcare

articles

• Initiated a process at CPSC for review of phthalates and phthalate alternatives

• Mandated appointment of seven member Chronic Hazard Advisory Panel (CHAP)

to study the effects on children’s health of all phthalates and phthalate

alternatives, as used in children’s toys and childcare articles

Toxicology

Phthalates are some of the most tested substances in commerce. They have

been reviewed by multiple regulatory agencies in the U.S. and Europe,

including CPSC.

Phthalates are odorless, do not give off gas and are designed to stay within

the polymer matrix, a significant property to extend the product usefulness.

NHANES biomonitoring data shows that humans are typically exposed to levels

thousands of times lower than those that produce the effects seen in some

laboratory animals.

Phthalates are rapidly metabolized and excreted/eliminated from the body.

Toxicology

Cumulative Risk

• The CPSC CHAP on phthalates has been charged with considering the

cumulative effect of total exposure to phthalates both from children’s products

and from other sources.

• The framework that CPSC has developed for this cumulative risk assessment

should be made available and peer reviewed since no federal agency has

released a cumulative risk assessment of phthalates to date.

Toxicology

Endocrine Activity

• Regulatory decisions about chemicals that may affect the endocrine system need to be based on several factors, including whether a chemical causes endocrine-related adverse effects and how these adverse effects are related to realistic levels and sources and pathways of exposure to the chemical.

• When screening substances for endocrine-related activity, especially when using emerging technologies, government agencies must use validated methods so the results can be relied upon, replicated and trusted by all stakeholders.

• Current screening studies are suitable for prioritization, not regulatory action.

• When conducting safety assessments, government agencies must use a “weight of evidence” approach, considering all relevant data, not relying on one piece of information.

• Study quality and reliability are key factors in high quality weight of evidence analysis.

Toxicology

Endocrine Activity

• Adverse health effects, from exposure to high doses of some phthalates, have

not been seen in primates and may not be relevant to human exposure.

• While most phthalates in commerce are not associated with endocrine effects, a few

have been found to interfere with normal sexual development in male rodents at

doses significantly higher than those typically experienced in humans.

• Mitchell et al. demonstrated that exposure of human fetal testes to a

particular phthalate is unlikely to impair testosterone production as it does in

rats.

• Work by Heger et al. demonstrated that human fetal testis xenographs are

resistant to phthalate-induced endocrine disruption.

• This has important safety implications.

Phthalates: Summary

• Phthalates are primarily used to soften or “plasticize” polyvinyl chloride

(PVC) or vinyl to create flexible vinyl products.

• The characteristics of an individual phthalate often make it well suited to

a specific product, allowing manufacturers to meet unique requirements for

its use.

• Key industry uses include: building and construction, wire and cable,

automotive, outdoor products and medical.

• Phthalates are some of the most tested substances in commerce and have

been reviewed by a variety of regulatory scientific bodies, including the U.S.

CPSC, the EU Chemicals Bureau and the Australian Government regulator of

industrial chemicals.

Phthalates

Questions and Answers

Phthalates

For more information please visit

www.AmericanChemistry.com/phthalates

Contact: Eileen Conneely

202-249-6711

Eileen_Conneely@AmericanChemistry.com