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Inclusion of HBCDD, DEHP, BBP, DBP and additive use of TBBPA in annex IV of the Commission's recast proposal of the RoHS Directive

3 Bis(2-ethylhexyl)phthalate (DEHP)

• 3.1 Main concern
• 3.2 Characterisation of the substance
• 3.3 Applications in EEE
• 3.4 Quantities of the substance used
• 3.5 Available alternatives
• 3.6 Socioeconomic impacts
  • 3.6.1 Substitution costs
  • 3.6.2 Impacts on supply chain
  • 3.6.3 Administrative costs
• 3.7 Impacts on health and environment
  • 3.7.1 Impact profile of substance and alternatives
• 3.8 Conclusions for DEHP

3.1 Main concern

The main concern as to DEHP is its possible effect on reproduction.

DEHP is (November 2009) included in the draft list of substances recommended by ECHA for inclusion in the list of substances subject to authorisation in Annex XIV of REACH.

DEHP is included in Annex I to Regulation No 1272/2008 (CLP) with the classification Repr. Cat.2; R61: May cause harm to the unborn child, Repr. Cat.3; R62: Possible risk of impaired fertility. DEHP is on the EU list of substances with endocrine disruption classifications, classified in CAT. 1 “Evidence for endocrine disruption in living organisms” (BKH, 2000).

Due to the possible effect on reproduction the substance shall not be used as substances or as constituents of preparations, at concentrations of greater than 0,1 % by mass of the plasticised material, in toys and childcare articles (Regulation No 552/2009). Further, it is not permitted for use in cosmetics (Directive 2004/93/EC)

An EU Risk Assessment has been finalised for DEHP (ECB, 2008b). With regard to human toxicity the risk assessment concludes that there is a need for limiting the risks for workers, consumers and humans exposed through the environment, taking the risk reduction measures already applied into consideration.

There is no classification and labelling for the environmental compartment. Measured bioconcentration factors show that DEHP can be accumulated in organisms at lower trophic levels, however, DEHP is not bio-magnified at higher trophic levels.

The review undertaken for the European Commission by Öko-institut e.V. as background for selection of candidate substances for a potential inclusion into the RoHS Directive (Gross et al., 2008) recommend DEHP as a potential candidate.

3.2 Characterisation of the substance

DEHP is a general purpose plasticiser used in flexible PVC. A few percent of the annual consumption of DEHP in the EU is used as plasticiser in other polymers and non-polymer uses such as for example in paints, adhesives, sealants, printing inks, etc. (COWI, 2009b). Phthalate plasticisers are always used as so-called external plasticisers, meaning that they are not bound chemically in the polymer matrix. They can therefore migrate out of the plasticised polymer by extraction with soapy water, oils, etc., by evaporation and by diffusion, and thereby become available for exposure to humans via inhalation, skin and diet, as well at to the environment.

The content of DEHP in flexible PVC varies but is often around 30% (w/w).

The structural formula for DEHP (CAS. No 117-81-7) is shown below.

DEHP

3.3 Applications in EEE

Possible uses of DEHP in EEE are shown in Table 3.1. The table shows the applications of flexible polymers in EEE. The polymers may be flexible PVC plasticised with DEHP, other polymers not containing DEHP, as well as PVC plasticised with other plasticisers than DEHP. It is not possible to point at exactly where the PVC plasticised with DEHP is used.

Except for a minor possible use of glues and sealants, the use of DEHP in EEE is as plasticiser in flexible PVC.

A particular use of DEHP in EEE has been the use in capacitors. According to a an assessment of DEHP use by University of Massachusetts Lowell the electrical capacitors industry sectors have largely moved away from the use of DEHP towards other chemicals (TURI, 2006.). An example of current use of DEHP capacitors are Dielektrol capacitors from the General Electric Company (GE, 2009).

Table 3.1
Potential (unconfirmed) uses of DEHP as plasticiser in EEE

Click here to see Table 3.1

3.4 Quantities of the substance used

The development in the EU use of plasticisers shows that the total consumption of DEHP deceased from 1999 to 2005 from 42% of the plasticiser market to 21% (Figure 3.1), with DINP and DIDP taking over (Cadogan, 2006).

According to resent assessments (COWI, 2009b), the total consumption of DEHP in the European Union was estimated at 291,000 t/y in 2007, of which an estimated 64,100 t/y, or 22%, was used for production (extrusion) of cable and wire. As such, production of cable is probably the largest single DEHP use in the EU. The EU production of cable and wire is estimated to be equal to the consumption, as import and export (of cable and wire) roughly equals each other (COWI, 2009b). This is assumed to be the case for cable and wire used for EEE manufacture as well. DEHP usage in cable and wire has decreased from an estimated 81,000 t/y in 1997 (ECB, 2008b). A very small part of the DEHP (7,000 t/y or 2%) is used for adhesives and sealant, but it should be noted that the total quantity used for these applications is still larger than the quantities of DBP and BBP used for adhesives and sealants.

A large share of the cable and wire produced is used for purposes outside the scope of the current RoHS Directive (in particularly in installations in buildings and industrial facilities), the exact share is however not known to us. Table 3.2 below shows the distribution (in Mio. €) of cable and wire production in the EU by applications. Based on background knowledge and global cable and wire production data (ICF, 2009), we assume that the cable used for EEE production includes less than half of the information cables (10% of the total), and 1/5 of the general wiring cable (another 10%); in total 20% of the production in the EU. Including the fact that flexible cable used in EEE is still dominated by PVC insulation and assuming that DEHP usage is equally distributed among cable types, 20% of 64,100 t/y equals some 13,000 t/y DEHP.

Table 3.2
Distribution (in Mio. €) of cable and wire production in the EU by application (from Europacable, 2009)

No detailed data were found on the consumption of other uses of DEHP in EEE. For such applications, consumption data only exist at aggregate level including al sorts of other products and items. For consumer electronics, for example, internal and external cables probably constitute at least half of the DEHP consumption based on expert judgement. The same likely applies to large household appliances, even if these include large PVC parts like PVC coated refrigerator baskets and door gaskets (which may or may not be flexible PVC). Using this approach we estimate some 10,000-20,000 t/y DEHP ending up in EEE in the EU.

Another approach is to estimate the DEHP amount on information of the consumption of PVC in EEE. Several studies on the composition of waste electrical and electronic equipment (WEEE) have tried to estimate the total PVC content of WEEE. An Irish study estimated on the basis of result of other studies that 5-10% by weight of the plastic fraction of WEEE would be PVC while Andersson (2005) quotes a study for the EU commission that 7% of the PVC was used for EEE in 1999.The total plastic consumption for EEE in 2007 in Western Europe and Central Europe is reported by PlasticsEurope to be about 2.5 million tonnes (PlasticsEurope, 2007). If 5-10% is PVC with a plasticiser content of 30% the total volume would be 37,000-73,000 t/y. If 20% of this was DEHP the total volume for DEHP in EEE would be approximately 7,000-15,000 t/year. In fact not all PVC in EEE is plasticised and the total DEHP volume would thus be lower.

Adding to this, a large part of the total end-user consumption of EEE is imported as finished goods from outside the EU This is notably the case for small household appliances, consumer electronics, IT equipment, and toys etc., but also for other EEE groups. At the same time some DEHP is exported with EEE from the EU.

On the basis of the calculations above we estimate that it is likely that EEE marketed in the EU contain some 5,000-20,000 t/y of DEHP.

3.5 Available alternatives

Today, the principle alternatives to DEHP are di-isononyl phthalate (DINP) and di-isodecyl phthalate (DIDP). These two substances are used widely in the EU as general plasticisers and have substituted for a large part of the former DEHP usage already. Also non-phthalate general purpose plasticisers exist, examples are alkylsulfonic phenylester (ASE), di-isononyl-cyclohexane-1,2dicarboxylate (DINCH) and di-ethyl-hexyl-terephthalate (DEHT). DEHT has for many years had a substantial market as general purpose plasticiser in the USA and also has a market in the EU. ASE and DINCH also have established markets, especially in sensitive applications such as toys, medical care articles and for food contact. With adjustments of the polymer/plasticiser formulations, and in some cases processing adjustments, these alternative plasticisers perform suitably as general purpose PVC plasticisers (COWI, 2009).

The evolution in the EU use of plasticisers shows that the consumption of DEHP deceased from 1999 to 2005 from 42% of the market to 21% (Figure 3.1). The DEHP was replaced by DINP/DIDP, while the non-phthalate plasticisers remained a market share of around 7-8%. The share of non-phthalate alternatives may have increased since 2005.

The use of secondary plasticisers, for example to improve plasticising performance and permanence at elevated temperatures as in electrical cables, is generally applied already, and a change of primary plasticiser is not expected to have major consequences as regards special performance requirements. Normal re-adjustment of the formulation of the system consisting of the polymer, primary plasticiser, secondary plasticisers and other additives will however likely be needed in most cases.

We cannot rule out completely that some niche productions for specialised purposes in some EEE may have difficulties in substituting DEHP, but no evidence of such niche production has been encountered in the preparation of this study.

Figure 3.1
Evolution of PVC plasticisers sales between 1999 and 2005 (based on Cadogan 2006)

3.6 Socioeconomic impacts

3.6.1 Substitution costs

The substitution costs will mainly fall at the PVC processors and formulators. For coatings and other integrated composite parts, the EEE manufacturers may act as PVC processors themselves, and may need to be involved in reformulation of the PVC plastisols or compounds used. The plasticiser producers will normally be involved in the substitution, because they act as advisors for the processors and formulators in the formulation of the polymer/plasticiser system. The alternative plasticisers are already developed and marketed, but costs for increasing the production volume may be implied. Costs for research in using alternatives for new applications will be furthered to the customers.

Table 3.3 shows price examples of DEHP and selected alternatives. As shown, DINP, DIDP and DEHT had comparable or slightly higher prices than DEHP, while DINCH and ASE had somewhat higher prices. Many PVC products are sold in highly competitive markets, and PVC processing industry is sensitive to even minor price changes on raw materials (TURI, 2006). DINP and DIDP seem to have been adopted well by industry, faced with regulatory pressure on DEHP.

Table 3.3
Examples of comparative prices of DEHP and selected alternatives (from COWI, 2009)

Notes: *1: DEHP price in 2006-2009 ˜0.8-1€/kg; 1€ is used for calculations. NA = Not available for this study.

Detailed data for estimation of other substitution costs than changed plasticiser prices have not been found. However, an example can be given from a large Danish toy company. When the Danish ban of six phthalates including DEHP, DINP and DIDP in toys and baby articles came into force, the production prices were initially raised by approximately 50 % because the international manufacturers had to produce special deliveries to the Danish marked without phthalates, but when the ban was implemented in the entire EU, the prices dropped again. The company estimates that the ban has resulted in a remaining price increase on the products of approximately 10-20 % for changing to non-ortho-phthalate plasticisers (COWI, 2009). This seems to be a reasonable estimate considering the price increases for the alternative plasticisers shown above.

Under the conservative assumption that production prices of plasticised PVC on average would rise corresponding to a 10% of raise in the plasticiser prise in a competitive market, the increased cost of substituting 1 tonne of DEHP by DINP would be approximately 100 €/t. With a total content of 5,000-20,000 tonnes DEHP, the total extra material costs would be 0.5-2 million €/y (European prices). The R&D costs of substituting DINP for DEHP is assumed to be relatively low. The costs of shifting to the less costly non-phthalate plasticisers may more likely be in the order of 100-300 €/t and with higher costs of R&D. If all DEHP was replaced by non-phthalate plasticiser the total costs would likely be in the range 1-6 million €/y. The costs may decrease over the years as result of a larger market for the alternatives.

For most EEE, the flexible parts which may contain DEHP comprise only a minor fraction of the equipment/product and thus also only a minor part of the total production price of the product. Further increases in consumer prices for EEE on average as a result of a restriction on DEHP use in EEE are therefore expected to be relatively small.

Note also, that considerable fractions of the flexible PVC used in EEE may already be plasticised with other primary plasticisers than DEHP; most probably with DINP or DIDP; this is however not included in the cost estimation above, which only refers to substitution of remaining DEHP consumption in EEE; i.e. change from the present situation.

3.6.2 Impacts on supply chain

SMEs
According to COWI (2009b), more than 400 manufacturers produce plasticised PVC products/parts of types, which may be of relevance for EEE. It is however not known how many of these actually produce EEE parts and how many are SMEs.

For most applications of DEHP a one-to-one replacement of DEHP with DINP will be possible and it is not expected that small and medium sized enterprises (SMEs) will be affected more than the general industry in the sectors in question with respect to the technical compliance. The plasticiser companies offering the alternatives are large companies, and they serve as general customer advisers when it comes to adjusting polymer formulations and production setup.

Previous studies have clearly indicated that SMEs are affected to a greater degree by compliance with the RoHS legislation compared to their larger competitors. The relatively larger burden for SMEs holds for total costs to comply with RoHS in general as well as more specifically the administrative burden (Bogaert et al., 2008). Some of the SMEs involved in the manufacturing of parts with DEHP (e.g. PVC tubes) may not already have procedures in place for ROHS compliance, and it must be expected that the relative cost burden will be higher for the SMEs when it comes to the administrative costs.

EU production
DEHP, DINP, DIDP, DINCH and ASE are examples of plasticisers produced by relatively large/multinational European based companies. DEHT is produced in the USA, the Middle East, Asia, and South America, but currently not in the EU.

Production of EEE is substantial in the EU, however a large part of the total end-user consumption of EEE is imported as finished goods from outside the EU. This is notably the case for small household appliances, consumer electronics, IT equipment, and toys etc., but also for other EEE groups.

For EU based EEE producers, DEHP containing parts may be produced by themselves or by subcontracting PVC processing companies in the EU as well as on the world market.

Differences in restriction of the use of the substance via the RoHS Directive or via REACH are discussed in section 1.3.

Impacts on waste management
The major part of the DEHP will by disposal of the waste EEE follow the wire fraction. Wires and cables are typically separated by chopping or stripping for recovery of the copper or aluminium parts (US EPA, 2008). The PVC may be recycled by different processes e.g. recycling into low-value PVC products or recovery of the polymer building materials (US EPA, 2008). The recycled PVC seems not to a significant extent to be recycled into new wires for EEE. The restriction of the use of DEHP in EEE consequently will not significantly influence the management of the wires from waste EEE.

Denmark, and perhaps other EU Member States have quality criteria for the concentration of DEHP in sewage sludge disposed off as fertilizer in agriculture (Danish BEK nr 56 of 24/01/2000), and elevated DEHP concentrations can therefore dictate the need for sludge incineration with resulting costs for society. The release of DEHP from EEE to waste water is however deemed minimal due to the nature of these products and the waste management schemes in place.

3.6.3 Administrative costs

Extra compliance costs related to the addition of one new substance under RoHS are expected to be minimal for companies which have already implemented RoHS, that is, most relevant companies. DEHP is typically used in parts where lead and cadmium have traditionally also been used (e.g. in pigments, stabilisers) and compliance documentation would usually be required for such parts. This cost element is therefore not assessed further here.

The main extra costs are estimated to be related to control; both by the manufacturers, importers and the authorities. The presence of DEHP cannot be determined by simple XRF screening, therefore sampling, extraction and laboratory analysis is required. The parts that may contain DEHP (e.g. PVC sheeting of wires) typically also may contain other RoHS substances e.g. lead and cadmium, but the presence of these substances can be determined by a simple XRF screening.

The extra costs would therefore comprise the costs of sampling, sample preparation and analysis.

Brominated flame retardants (e.g. the PBDEs) and phthalates can be extracted by the same organic solvents and analysed using the same GC-MS analysis (gas chromatography followed by mass spectroscopy), however, usually the materials containing the brominated flame retardants are different from the materials containing phthalates. The price of an analysis of DEHP in a flexible PVC is in Denmark is reported to be about 160 € (excl. VAT) while the total price of analysing for DEHP, DBP and BBP is about 190 € (excl. VAT).The extra costs of analysing for DBP and BBP if analysis for DEHP is already done is thus about 30€ (excl. VAT). All prices are per sample when more than 20 samples are analysed.

3.7 Impacts on health and environment

3.7.1 Impact profile of substance and alternatives

Environmental and health properties of alternatives to DEHP, DBB and DBP have reviewed for ECHA (COWI, 2009a,b,c) as part of the evaluation of substances for inclusion of substances on the candidate list of SVHC for authorisation. These alternatives as well as other alternatives have further recently been reviewed in a study for the Danish EPA (Maag et al., 2009).

Study for the Danish EPA on environmental and health properties of alternatives to DEHP, DBP and BBP
The results of the study as regards environmental and human health properties of DEHP, DBP and BBP and alternatives are summarised in Table 3.4. The data for DBP and BBP are further discussed in the next chapters. Reference is made to the original study for details. Data for DEHP, BBP and DBP, based on data in the Risk Assessment of each substance is summarized in the table using the same notation on the basis of data from the EU risk assessments. The table includes substances that are mainly alternatives to DBP or BBP. As the substitution is typically not a one-to-one substitution, but often is a replacement of one plasticiser system (e.g. with DEHP as primary and DBP or BBP as secondary plasticiser) with another system (with more substances together), it is convenient to keep the information on all the substances together in one table.

DINP and DIDP were not evaluated in the study, but human health properties of DINP compared with DEHP is discussed further below with reference to an evaluation made by the scientific committee SCENIHR.

The results from the EPA study indicate that a number of alternatives to DEHP exist which may potentially be less problematic than DEHP with regard to human health effects. However, for most of these substances data are missing for critical endpoints, in particular for carcinogenicity, where tests are only available for 3 out of 10 potential alternatives. Compared to DEHP and based on the available studies, the alternatives appear to be less toxic than DEHP. Like DEHP, all except GTA, have some effects on body weight, liver or kidney in repeated dose toxicity studies. With regard to reproductive toxicity, 3 of the 10 studied alternatives have some indication of developmental effects, although with considerably higher NO(A)EL values compared to DEHP. For 3 alternatives carcinogenicity is studied in combined chronic toxicity/carcinogenicity studies with negative outcome. Only one study was a guideline study.

With regard to environmental effects of the alternatives, useful fate data regarding biodegradability (in water) and bioaccumulative properties (either as bioconcentration factor(BCF) or log K_OW) are available for all alternatives while other fate data are quite variable and incomplete. With regard to ecotoxicological effect data, results from short-term tests with the base-set of organisms - fish, crustaceans and algae - exist for all 10 substances although the duration of some studies deviate from the current OECD standard.

None of the alternatives are considered PBT or vPvB substances. One of the 10 studied substances did not show any aquatic toxicity and is also not considered persistent or bioaccumulative whereas the other substances show positive results in one or more of these areas. From an environmental point of view only few of the substances stand out as less problematic compared to DEHP.

Table 3.4
Overview of main toxicological and ecotoxicological properties of DEHP, DBP, BBP and potential alternatives. For alternatives the summary is based on Maag et al., 2009; for DEHP, BBP and DBP data has been extracted from the EU Risk Assessment reports.

Click here to see Table 3.4

SCENIHR evaluation of human health profiles of DEHP and alternatives
A number of alternative substances have been evaluated by the Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR)with regard to the safety of medical devices containing plasticized PVC on neonatates and other groups possibly at risk. The alternative plasticisers were evaluated for their potential toxicity and ranked according to toxicity and leaching. The results for the human toxicity part of the Danish EPA study mentioned above, is in accordance with the findings of the SCENIHR for the substances evaluated in both studies.

To compare the toxicity, a short summary of the potential genotoxicity, the carcinogenicity, repeated dose toxicity and reproductive toxicity were summarised (Table 3.5). In this table (as well as in Table 3.6) the NOAEL is shown as the lowest effects in male or female rat. Available information on the leaching behaviour of alternative plasticisers was sparse, but in general appears to be of the same order of magnitude as that of DEHP.

Table 3.5
NOAEL of DEHP compared with some alternative plasticisers. The critical endpoint is shown to indicate that for some of the chemicals it is different from reproductive effects (SCENIHR, 2008)

bw: body weight
*1 Kidney effects in male rats due to alpha-2-u macroglobulin, a mechanism not relevant to man.
*2 No data for exposure range for alternatives indicated by SCENIHR (2008).

According to the SCENIHR, considering similar leaching rates, the margin of safety of other plasticisers will be at least 20 times higher for most alternatives. The toxicological profile of DEHP and the alternative plasticisers with respect to repeated dose toxicity, genotoxicity, carcinogenicity and maternal toxicity is shown in Table 3.6.

Table 3.6
Comparison of the toxicological profiles of DEHP and potential alternatives to its use (SCENIHR, 2008)

The SCENIHR concludes that DEHP causes the most severe effects on reproduction in animal studies evaluating toxicity. DEHA, DINP, and TOTM also caused reproductive toxicity, but in doses more than 20 times higher than that of DEHP. COMGHA and TOTM could not be evaluated for all endpoints due to lack of data.

Regarding the alternatives, for some compounds sufficient toxicological data were available to indicate a lower hazard compared to DEHP. For others, information on the toxicological profile was inadequate to identify the hazard. This limits according to SCENIHR the proper evaluation of the potential to replace DEHP by alternative plasticisers. According to SCENIHR the risks and benefits should be carefully evaluated for each individual medical device and each medical procedure in which the alternative needs to be used.

Summary of data on alternatives
Both assessments, referred to above, emphasise that data on alternatives are not sufficient for making a robust conclusion, especially with regard to human health effects.

Many of the alternatives have some demonstrated potential health effects in repeated dose toxicity studies and in relation to reproduction toxicity. The available data do however indicate that most of the alternatives are less problematic than the DEHP with regard to human health, but data are missing for critical endpoints, in particular carcinogenicity. When comparing the known toxicity of the alternatives with DEHP based on the NO(A)ELs for the most critical effect, reproductive toxicity, the alternatives in both assessments show these effects at much higher doses.

The available data indicate that a number of alternatives exist which do not meet the PBT criteria, but for which more details and evaluation is necessary to conclude about their environmental effects compared to DEHP. However, based on the Danish EPA assessment DINA and GTA appear to be more environmentally friendly compared to DEHP whereas the other 8 substances have positive responses for more than one of the effects: persistence, bioaccumulation and toxicity. One substance, DEGD, has only positive response for aquatic toxicity, but this is in general considered more serious compared to a substance which like DEHP is bioaccumulative, but not persistent. With regard to endocrine disruptive effects DEHP is as mentioned on the EU list of substances with clear evidence of endocrine disrupting effects. None of the alternatives are on the list and data for this endpoint has not been available for evaluation in the Danish EPA assessment. With regard to the overall assessment, negative environmental effects will have to be considered against less problematic human health effects.

3.8 Conclusions for DEHP

The main concern as to DEHP is its possible effect on reproduction. According to the EU Risk Assessment Report DEHP is bioaccumulative but is not considered a PBT substance or a vPvB (very persistent and very bioaccumulative) substance. With regard to CMR effects, DEHP raises concerns based on reproduction toxicity studies showing testicular effects, effects on fertility, toxicity to kidneys, on repeated exposure and developmental toxicity. DEHP is classified toxic to reproduction.

DEHP is mainly used in EEE as a plasticiser of flexible PVC used for wires, plugs, tubes and a number of other parts. It may in principle be found in nearly any EEE. The exact consumption for EEE is not known, but it is likely that EEE marketed in the EU contain some 5,000-20,000 t/y of DEHP.

The use of DEHP in EEE is not deemed essential as technically suitable alternatives are available and already used extensively today. The main alternatives that in recent years have taken over the major part of the former DEHP consumption are the phthalates DINP and DIDP. If DEHP is restricted in EEE these alternatives will most likely take over a major part of the remaining uses. A number of non-phthalate alternatives are marketed, however, the price of these alternatives are in general somewhat higher.

Costs - It is estimated that the incremental material costs (at manufacturing stage) would be 0.5-2 million €/y (European prices) if DINP is used to substitute for DEHP in all EEE (within or outside of the scope). In this case the R&D costs is assumed to be relatively low. The total costs of shifting to the cheapest of the non-phthalate plasticisers is higher and would likely be in the range 1-6 million €/y.

Substitution may result in slightly raised prices for flexible PVC parts in the EEE. For most EEE, the flexible parts which may contain DEHP comprise only a minor fraction of the equipment and represent only a minor part of the total production price of the product. Increases in consumer prices for the individual EEE as a result of a restriction of DEHP use in EEE are therefore expected to be small, but a restriction may impact a large share of all EEE.

The main extra administrative costs are estimated to be related to compliance control, where the extra costs would comprise the costs of sample preparation and analysis. DEHP is typically used in plastic components where lead and cadmium have traditionally been used as pigments and/or stabilisers; however these can be determined by a XRF screening. The phthalates are typically used in other plastic parts than the brominated flame retardants. The price of analysis for DEHP, DBP and BBP is nearly the same as for analysis of DEHP only.

Benefits - Available data for the alternatives indicate that with regard to human health effects less problematic alternatives exist. This conclusion is primarily based on data for repeated dose toxicity and existing reproductive toxicity data. However, most of the alternatives are not fully investigated with regard to reproductive toxicity and in particular with regard to carcinogenicity. The environmental assessment of the alternatives does not lead to the same conclusion as most of the alternatives investigated in the Danish EPA study must be considered as more problematic for the environment compared to DEHP.

With regard to DINP and DIDP, both substances show reproductive toxicity but at higher doses compared to DEHP. Also from an environmental point of view the two alternatives seem to provide a choice for more environmentally friendly alternatives based on the conclusions in the EU risk assessment reports.

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Version 1.0 March 2010, © Danish Environmental Protection Agency