Evaluation of Plasticisers for PVC for Medical Devices, Miljøstyrelsen

Evaluation of Plasticisers for PVC for Medical Devices

Appendix 1
Plasticiser performance matrix

Performance matrix for plasticisers for PVC for medical applications

Liquid substances

Solid substances

Substances derived from natural products

21 June 2002

Plasticiser substance group

DEHP^EU)

DINP^EU)

DIDP^EU)

Other phtha- lates

Adipates

Tri- mel- litate TEHM

Citrates

Ben- zoates

Alkyl- sulpho- nate of phenol (ASE)

Phos- phates (orga- nic)

Epo- xies (ESO, ELO)

Seba- cates DEHS

Aze- lates DEHZ

Naph- the- nates

Poly- hydric alcohol esters

All- phatic glycol esters

EAC Ter- poly- mer

Nitrile rubber

Polyure- thane

Ethylen- vinyl- acetat copo- lymer EVAC

Metal- locene cata- lysed polyo- lefines

Destil- led acety- lated mono- glyce- ride

Esters from palm oil

Esters from castor oil

Esters from corn oil

Esters from rape- seed oil

Plasticiser selection criteria

DEHA

Other mono- meric

Poly- meric

Acetyl- tri- butyl- citrate (ATBC)

Acetyl- tri- hexyl- citrate (ATHC)

Butyryl- tri- hexyl- citrate (BTHC)

Commer- cial availa- bility

Readily available

Readily avail- able but some diffe- rences iso-C9 alcohol distri- bution. Some medical compound usage.

Readily avail- able.
Some medical compound usage.

Readily avail- able.
Mainly used for specia- lised appli- cations. No known use in medical com- pounds.

Readily avail- able.
Some medical com- pound usage.

Avail- able but fewer suppliers than DEHA. No known use in medical com- punds.

Avail- able in "medi- cal" grade but limited number of sup- pliers.

Avail- able in "medi- cal" grade but only four or five sup- pliers world- wide.

Avail- able but limited number of sup- pliers. Some medical com- pound use.

Avail- able but limited number of sup- pliers. No date on medical appli- cations.

Avail- able but limited number of sup- pliers. Possible skin sensiti- sation issues.

Readily avai- lable but limited number of suppliers. No known use in medical com- pounds.

Single source. General purpose PVC com- pounds. No known use in medical com- pounds.

Readily avail- able. Several different types. No known or expected use in medical com- pounds

Readily avail- able. Wide- spread use in medical com- pounds.

Readily avail- able from many sup- pliers. No known use in medical com- pounds. Ex- tensive use in food contact and cosmetic applica- tions.

Avai- lable but only a limited number of sup- pliers. Azelaic acid is virtually a single source raw material.

No supplier found

Avail- able but only a limited number of sup- pliers. No known use in medical com- pounds.

Avail- able but only a limited number of sup- pliers. Used for antistatic PVC com- pounds. No known use in medical com- pounds.

Single source. Solid plastic- iser nor- mally used in con- junction with a liquid primary plastic- iser.

Several sources. Solid plastic- iser nor- mally used in con- junction with a liquid primary plastic- iser.

Single source.
Solid plastic- iser nor- mally used in con- junction with a liquid primary plastic- iser.

Several sources. Solid plastic- iser nor- mally used in con- junction with a liquid primary plastic- iser.

Not readily avail- able. Poor compa- tibility with PVC

Commer- cially avail- able but only in font="-1" quanties. No known use in medical com- punds.

No known usage as PVC plastic- iser.

Unknown

No known usage as PVC plastic- iser.

Compa- tibility with PVC resins

Good

Fair

Limited

Good

Pro- bably satis- factory but more data re- quired

Pro- bably satis- factory but more data required

Probably satis- factory but more data required

Good

Gene- rally fair although a few types only have limited compa- bility.

Limited com- pability. Used as secon- dary plastic- isers and stabil- isers.

Fair. Nor- mally used as a secon- dary plastic- iser.

Unknown

Fair. Normally used as a secon- dary plastic- iser.

Unknown but probably fair.

Fair

Unknown. More data required.

Poor

Unknown

Plastic- ising effi- ciency index

100

105

110

90-125

95-100

92-102

120-150

117

Approx. 100

95-100

Approx. 100

110-150

110

Unknown

Poor effi- ciency

Poor efficiency

Poor effi- ciency

Unknown

Process- ability

Com- poun- ding

Refe- rence

Similar to DEHP but possibly more "fish- eyes"

Similar to DEHP. However <C8 will progress easier & <C8 will be more difficult.

Slightly more difficult than DEHP.

Difficult

Slightly more difficult than DEHP.

Similar to DEHP but many dis- colour quicker.

As ATBC

Unknown

Slightly easier than DEHP

Similar to DEHP

Difficult

More difficult than DEHP

As DEHP

Unknown

Highly volatile

Difficult to process

Unknown

Com- ponent manu- facture

Injec- tion moul- ding

Refe- rence

Similar to DEHP

Generally similar to DEHP

As DEHP

More difficult than DEHP

Similar to DEHP

As DEHP

Unknown

Sup- plier's litera- ture indicate no problems

As DEHP

Unknown

Not used on its own (used as 4 - 12 phr.)

As DEHP

Unknown

Volatile

Unknown

Very difficult to injection mould

Difficult to injection mould

Unknown

Ex- trusion

Refe- rence

Slightly more difficult than DEHP

Generally similar to DEHP

As DEHP

More difficult than DEHP

Similar to DEHP

As DEHP

Unknown

Sup- plier's litera- ture indicate no problems

As DEHP

More difficult than DEHP

Not used on its own (used as 4 - 12 phr.)

As DEHP

Unknown

Volatile

Unknown

More difficult than DEHP

Unknown

Calen- dering

Refe- rence

Higher proces- sing tempe- ratures required (> 2 deg. C)

Generally similar to DEHP

As DEHP

More difficult than DEHP

Similar to DEHP

Sup- plier's litera- ture indicate no problems

As DEHP

Not used on its own (used as 4 - 12 phr.)

As DEHP

Unknown

Volatile

A blend with DEHP was difficult to process. Com- pound was satis- factory.

Unknown

Fabri- cation opera- tions

Solvent welding

Refe- rence

Similar to DEHP

Generally similar to DEHP

As DEHP

Unknown

As DEHP*

Unknown

Satis- factory

Not used on its own (used as 4 - 12 phr.)

Unknown

High fre- quency welding (HF)

Refe- rence

Similar to DEHP

More difficult as efficiency index increa- ses*

As DEHP

As DEHP*

Unknown

As DEHP (Supplier claim it to be better)

Satis- factory

Not used on its own (used as 4 - 12 phr.)

Unknown

As DEHP*

Unknown

Ad- hesive jointing

Refe- rence

As DEHP*

As DEHP

Unknown

As DEHP*

Unknown

Not used on its own (used as 4 - 12 phr.)

Unknown

Machin- ability

Refe- rence

As DEHP*

As DEHP

As DEHP*

Satis- factory

Unknown

As DEHP

As DEHP*

Not used on its own (used as 4 - 12 phr.)

Unknown

Printa- bility

Refe- rence

As DEHP*

As DEHP

As DEHP*

Satis- factory

Unknown

Used for printed flooring

As DEHP

Satis- factory*

Not used on its own (used as 4 - 12 phr.)

Unknown

Used for printed flooring

Unknown

Post fabri- cation opera- tions

Sterili- sation

Radia- tion sterili- sation

Refe- rence

As DEHP

As DEHP*

Unknown

As DEHP

Unknown

As DEHP*

As DEHP

Unknown

Consi- dered as a benefit

Similar to DEHP

As DEHP

Unknown

Ethy- lene oxide sterili- sation

Refe- rence

As DEHP

As DEHP*

Unknown

As DEHP

As DEHP*

Unknown

Satis- factory at 4 - 12 phr.

Similar to DEHP

As DEHP

Unknown

Steam sterili- sation

Refe- rence

Slightly more tolerant than DEHP*

Probably similar to DEHP

Solu- bility may be an issue

Unknown

As DEHP*

Some hydro- lysis ex- pected*

Some hydro- lysis expected*

Unknown

Satis- factory at 4 - 12 phr.

Similar to DEHP

As DEHP

Unknown

Cost

Material cost index

100

110

120-200

275

120-140

350-700

275-300

600

500

1000

200

100-120

250-400

120-150

450-700

500-700

Unknown

500

400-500

500-600

400

500-600

Unknown

Pro- cessing cost index

100

100*

110*

120-200

120

140

150-200

120-140

150

Unknown

As DEHP

150

120

120-140

Unknown

Regu- latory status

Food contact

Toxico- logy

Approved for food contact with limita- tions and for medical appli- cations

FDA, Beve- rage hoses Germany (BgVV/ BGA)

Unknown

Re- stricted food contact approvals exists.

Some food contact appro- vals depen- dant on level. At least two suppliers.

Used for blood bags and infusion sets.

Accep- ted by FDA for food wrap appli- cations. Listed in the EEC Directive 90/128.

No data from supplier

FDA appro- ved for blood bags.

FDA appro- ved for food packa- ging

BgVV appro- ved

A grade i FDA approved for food packa- ging

Listed in the USP and the EP

Physio- logically satis- factory. Ex- tensive FDA appro- vals.

Some FDA appro- vals

Unknown

Food contact grades available.

Food contact grades available. Meets BgVV require- ments.

Unknown

Handling, health and safety

Physical/ chemical

EP mono- graph

Listed

Not listed

Unknown

Drug compa- tibility

Possible problem with liquid soluble drugs, insulin

Unknown

Unknown migration and solubility may be a problem

Unknown

As DEHP

Unknown

Biolo- gical

USP Class VI

Cyto- toxicity

Unknown

A number of toxicity tests have been per- formed.

Unknown

As DEHP

Unknown

Heamo- lysis

Unknown

As DEHP

Unknown

Systemic. tox.

Unknown

As DEHP

Unknown

Intra- cuta- neous

Unknown

As DEHP

Unknown

Implan- tation

Unknown

As DEHP

Unknown

Environ- mental status

Environ- mental classifi- cation

67/548/ EEC
Annex I + 26
ammend- ment
(2002/32/ EF)

Not classi- fied

Not clas- sified

Some are clas- sified

Not classified

Not clas- sified

Di- ethylene glycol diben- zonate and dipro- lyene glycol diben- zoate are not classified.

o- Toluene- sulphon- amide is not classified.

Di-2- ethyl- hexyl phos- phate and tri-2- ethyl- hexyl phos- phate are not classified.

ESO is not clas- sified

Not classified

Not clas- sified

Not classified

Unknown

Not classified

Unknown

Emis- sions

- during manu- facturing

Refe- rence

Expected to be similar to DEHP

Higher volatility than DEHP
(5 x)

Signifi- cantly lower volatility

Signifi- cantly lower volatility
(1:5)

Venti- lation re- quired

Good ven- tilation re- quired

Suppliers claim low volatility

Similar to DEHP

Unknown

Non hazar- dous

Similar to DEHP

Unknown

Highly volatile

Hazar- dous fumes

Hazardous fumes (HCN risk)

Hazar- dous fumes (HCN risk and other nasties)

Acetic acid emitted*

Unknown

- in use

Refe- rence

Slightly less than DEHP

Unknown

Higher volatility than DEHP
(5 x)

Signifi- cantly lower volatility

Signifi- cantly lower volatility
(1:5)

As DEHP*

Unknown

Good ven- tilation re- quired

Suppliers claim low volatility

Similar to DEHP

Unknown

Non hazar- dous

Similar to DEHP

Much as DEHP

Unknown

Highly volatile

Unknown

Incine- ration of final product according to the EU directive

No issues

No issues expected

Unknown

Possible acidic fumes*

No issues*

Potential issues with SO₂ emis- sions and residues

Possible toxic emissions during incine- ration

Non hazar- dous

Similar to DEHP

Unknown

Hazar- dous fumes

Hazardous fumes (HCN risk)

Hazar- dous fumes (HCN risk and other nasties)

Acid fumes produced during incine- ration

Unknown

Sustain- able develop- ment

Oil based

Partially oil based

Oil based

Coal tar or oil based

Natural product based

Partly natural (Castor oil)

Partly natural based

Unknown

Oil based

Partly oil based

Oil based

Unknown

Physical pro- perties of plastic- iser

Aesthetic pro- perties

Odour

Colour- less

Pale yellow

Colour- less

Light yellow

Colour- less

Unknown

White granules

Yellow powder

White powder

Unknown

Clarity

Excel- lent

Excellent

Ex- cellent

Excellent

Good

Excellent

Good

Colour- less

Unknown

Clear com- pound

Semi opaque

Fair

Unknown

Odour

Slight odour

Odour present

Mild odour

Odour- less???

Mild odour

Odour- less

Unknown

Smell of acetic acid

Typical NBR odour

Odour- less*

Unknown

Physical pro- perties of com- pounds

Mecha- nical pro- perties (refe- rence Shore A 80)

Tensile pro- perties

Ade- quate

Depends on primary plastic- iser

Good

OK (10 % less than DEHP)

Unknown

As DEHP

Unknown

Good

Poor

Unknown

Cold flexi- bility

Good

Slightly better than DEHP

Linear phtha- lates better than equi- valent branched

Good

Slightly worse than DEHP

As DEHP

Slightly better than DEHP

Better than DEHP

Slightly worse than DEHP

Most are poor

Slightly worse than DEHP

Excellent

Very good

Unknown

Poor

Good low tempe- rature proper- ties

Unknown

Poor

Good

Unknown

Elastic recovery

Slow but accep- table

Slow

As DEHP*

Unknown

As DEHP

Poor

Depends on primary plastic- iser

Excellent

Unknown

Good

Unknown

Public per- ception

Politi- cally in- correct

Per- ceived as more favou- rable than DEHP

Per- ceived as more favourable than DEHP

Unknown

None

Good

None

Occu- pational safety and health problems reported

None

Slightly poor

None

Unknown

Data refers to Shore A 80 compounds
EU) Phthalates being assessed by EU
"Unknown" means unknown to the working group at the moment
* Knowledge assumed from DEHP