Environmental and Health Assesment of Alternatives to Phthalates and to
flexible PVC

3. Introduction and approach  

3.1 Background  
3.2 Approach
3.2.1 Data search and substance selection
3.3 Properties information
3.3.1 Data collection
3.3.2 Estimation of exposure
3.3.3 Assessment
3.3.4 Combined assessment

3.1 Background  

A total of 20 million tonnes of PVC is produced globally every year. Recent statistics from the Association of European Plastic Converters states that production in Western Europe is 4.2 million tonnes of rigid and 3.7 million tonnes of flexible PVC(EU Commission 2000)

Plasticisers are necessary to manufacture flexible PVC products and may in the product constitute from 15 to 60% (Gächter, Müller 1993) depending on the final application with a typical range between 35 - 45%. At present a range of phthalates constitute the vast majority of plasticisers for PVC (in 1997: 93%) and approximately 900,000 tonnes are used annually in Western Europe. Other plasticisers, in particular adipates, trimellitates, organophosphates and epoxidised soy bean oil can also be used in PVC, but constitutes only a fraction of the present total consumption (EU Commission 2000).

Five of the phthalates have been put on priority lists for risk assessment due to the potential for human health and environment effects, and some are already under assessment by the EU. In Denmark an action plan has been adopted to reduce the use of phthalates with 50% over the next 10 years. In Sweden the usage of the main phthalate DEHP (diethylhexylphthalate) is to be reduced, and in Germany the Umweltbundesamt recommends a phase-out of flexible PVC where safer alternative exist. It is therefore expected that the need for alternatives to the existing plasticisers will grow.

The present project is a general assessment of the use, exposure, and possible health and environmental effects of several alternative plasticisers and of two materials suggested for substitution of flexible PVC.

3.2 Approach

The DEPA has presented a list of substances and groups of substances for the study, which were suggested as possible alternatives to phthalate plasiticisers, and two materials suggested as alternatives to flexible PVC. A health and environmental assessment, including exposure, was requested. The list comprised:

Tabel 3.1 List of substances suggested as possible alternatives to phthalate plasiticisers

In the following an overview of procedures and activities of the assessment is presented. A more detailed description is given in the introduction to the presentation of the result of each activity.

Figure 3.1 Overview of procedures and activities of the assessment.

3.2.1 Data search and substance selection

Identification of phthalate usage
The selection of example substances and materials were based on informa-tion on the present uses of phthalates, i.e. information from the industry and from The Danish Product Register (PR). Especially, the usage as plasticiser was emphasised.

Use estimation
The use of PVC and phthalates herein was taken from the report on mass balance of phthalates for Denmark from 1996 (Hoffmann 1996) and from the Inventory of the Industry (2000).

Preliminary data on substance properties
From a number of databases and other readily available information sources preliminary data collection on properties was performed on the five sub-stances and on a number of suggestions for additional substances as exam-ples for groups of substances. This information was compiled into data sheets and given a preliminary review.

Selection of substances for assessment
Based on the information on use pattern, volume, and the screening data, six substances were chosen as examples of their group and for this total of 11 substances a more comprehensive data collection took place.

3.3 Properties information

3.3.1 Data collection

Databases used
The data collecting includes searches for original literature in bibliographi-cal databases and searches in the following databases directed towards rele-vant toxicological and ecotoxicological properties.

• Chemfinder, CHEMFATE, ENVICHEM, TOXALL
• ECOTOX: Aquire, Terretox, Phytotox
• Hazardous Substances Data Bank (HSDB)
• Oil and Hazardous Material Technical Assistance Data System
• International Uniform Chemical Information database (IUCLID)
• Handbook of environmental data of organic chemicals ("Verschueren")
• SAX's Dangerous properties of industrial materials

The most relevant reference sources from the listed database outputs have in addition been procured. In most cases these references are reviewed litera-ture and not the original sources. This means that the evaluated effects are not always described in detail but often in more general terms like 'slightly irritating' or 'moderately toxic'. A more precise evaluation is therefore not possible and also not a precise evaluation against the classification criteria in the Substance Directive (EU, 1967).

Quality assessment of data for the environmental hazards of chemicals is based on the procedures in Pedersen et al. (1995)

3.3.2 Estimation of exposure

Worst case
As a first step, a hypothetical worst case scenario was included for each sub-stance assuming a total change of all phthalate consumption to one single substitute. This number was also used in exposure calculation.

Substitution matrix
Estimation of exposure in a future substitution scenario was attempted by establishing a 'realistic' use pattern scenario for all the substitutes in PVC applications. This was performed with a substitution matrix showing the use pattern in use groups. From this matrix the maximum usage in tonnes for an application was used for the exposure calculation.

Exposure
The exposure was calculated for workers, consumers, humans exposed via the environment and the aquatic and terrestrial environment by using the EUSES programme (European Chemicals Bureau 1996) based on the EU Technical Guidance Document on risk assessment of chemicals (EU 1996).

3.3.3 Assessment

Where incomplete information on physical-chemical, toxicological or eco-toxicological properties was identified in data sheets a renewed information search was performed.

Health
The health assessment is based on available data from animal studies re-flecting all relevant exposure routes and toxicological effects. Observations in humans are included where available. These data are presented in the data sheets included in Appendix 1. In the data sheets the most significant test results are highlighted (marked with ¨) and these results are presented in chapter 5 along with an evaluation of each substance. Calculations using the EASE model are used to estimate the possible exposure from selected use scenarios in the work environment and to the consumer. The estimated ex-posure is compared to the doses and effects seen in the described animal studies and to the exposure levels and related effects observed in humans.

Environment
The environmental assessment is built around the exposure data provided by the EUSES for a number of compartments for which relevant ecotoxicologi-cal test data have been searched. These include test with algae, crustaceans and other invertebrates, fish, micro-organisms, and terrestrial organisms. Other test data have also been included where relevant. For each of these groups of organisms the data are presented in the datasheets provided in the appendix and the key data for the assessment are marked. A more detailed description of the key data is presented in chapter 5 along with a summary description of the substance data. The (eco)toxicolgical data are not entered into EUSES, because of a typical lack of the type of test data needed to comply exactly with EUSES. The risk is estimated by comparing predicted environmental concentrations (PEC) and predicted no-effect concentrations (PNEC).

The parameters on partitioning and degradation are also discussed under 'Environment'. These values also enter EUSES and influence the exposure calculations. These are octanol-water partition coefficient, bioconcentration factor (BCF), soil or sediment-water partition coefficient, and aerobic and anaerobic biodegradation.

3.3.4 Combined assessment

The sources of the data are given primarily in the data sheets in the report appendix and for core information also in the main report. The information includes peer reviewed original papers, databases, previous reviews and re-ports, books, and proprietary information from suppliers. The combined as-sessment is found in chapter 7.

It has been attempted to prioritise studies performed after standard test methods and guidelines for inclusion. In a number of cases the database IUCLID, which contains information submitted by the industry, is almost the sole data source. Again, standardised tests have been selected whenever possible.

The core physical-chemical properties considered are the hazardous proper-ties, such as corrosiveness, flammability etc.

The choice of properties for human toxicity has been based on the hazard indicators for humans as mentioned in CSTEE (2000), i.e. carcinogenicity, reproductive and developmental effects, mutagenicity, sensitisation and se-vere organ toxicity supplemented with assessment of acute and/or local ef-fects. For the environment the properties evaluated are the three core prop-erties of the hazard classification scheme of EU (Commission of the Euro-pean Communities 1993), i.e. persistence (biodegradation), bioaccumulation and acute toxicity to algae, crustaceans and fish of the chemical substance.

In addition to evaluating hazards, the risk is also assessed. For humans this is achieved by comparing the estimated dose of the substance in consumer and environmental exposure with existing or estimated acceptable daily dose (ADI). For the environment the environmental risk quotient is calculated from PNEC and estimated environmental concentrations.

Other important properties with respect to the potential use areas of the sub-stances and materials are the volatility and migratory properties. Compari-son of these properties will also be carried out, although no recommendation regarding technical uses will be made.