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K-REACH Polymers

In Korea polymers are not generally exempt from K-REACH. They are divided into two groups: PLCs (Polymers of Low Concern) need an exemption dossier and non-PLCs need a full dossier according to K-REACH requirements.

LAUS can support you with studies for the characterization of your polymer and for dossier endpoints.

Characterization for all Polymers

All polymers have to be characterized in order to determine whether they are PLCs or non-PLCs.

Polymer Characteristics:
- Number average molecular weight and molecular weight distribution
- Monomer composition information: monomer name and content (%) and content of residual monomers (%)
- Content of MW 1,000 or less(%)
- Stability in acidic and alkaline condition

 

PLCs can be described according to the following criteria:

- Polymers Mn ≥ 10,000
Mw < 1,000: < 5%
Mw < 500: < 2%

- Polymers Mn ≥ 1,000 ∼ < 10,000
Mw < 1,000: < 25%
Mw < 500: < 10%

Mn: number average molar mass determined by GPC

Mw: mass average molar mass determined by GPC

Excluded from PLCs are:

  1. Cationic polymers (except cases used only in its solid state, as polymers not dissolved or dispersed in water)
  2. Polymers Mn < 10,000, if 2 % of monomers/reactants are a “New chemical substance” or a “Chemical substances designated by MOE”

 

For all polymers basic physico-chemical properties have to be determined:

 

Test Method OECD TG

All polymers

Physical state

 

X

Water solubility

105

X

Melting/freezing   point

102

X

Boiling point

103

W

Vapor pressure

104

W

 

Data Requirements for non-PLCs (non- “Polymers of Low Concern”)

Physico-chemical Properties

 

Test Method OECD TG

1-10 t/a

10-100 t/a

100-1,000 t/a

>1,000 t/a

Partition coefficient n-octanol/water

117, 107, 123

   

W

W

Relative density

109

   

X

X

Granulometry

110

   

X

X

Flammability

 

     

W

Explosive property

 

     

W

Oxidizing property

 

     

W

 

Toxicology

 

Test Method OECD TG

1-10 t/a

10-100 t/a

100-1,000 t/a

>1,000 t/a

Acute oral toxicity toxicity (or inhalation) *)

423 (403)

 

x

x

x

Acute dermal toxicity (or inhalation) *)

402, 403

     

x

Skin corrosion/irritation*)

404
IVT

   

x

x

Eye corrosion/irritation*)

405
IVT

     

x

Skin sensitization*)

406/429
IVT

   

x

x

Ames test

471

 

x

x

x

In vitro chromosome aberration

473/487

     

x

In vivo gene mutation*)

       

x

Repeated toxicity (28 days) *)

407/410/412

     

x

Screening for reproductive/development toxicity*)

421/422

     

x

 

Ecotoxicology

 

Test Method OECD TG

1-10 t/a

10-100 t/a

100-1,000 t/a

>1,000 t/a

Short-term fish toxicity

203

 

x

X

X

Short-term daphnid toxicity

202

   

X

X

Algae growth inhibition

201

     

X

Ready biodegradability

301/310

 

W

W

W

Hydrolysis as a function of pH

111

     

W

x: GLP study required

X: non-GLP study sufficient

W: Waiving possible

*): subcontracted study

IVT: in vitro alternative available

 

Please, don’t hesitate to contact us if you would like to receive further information or a proposal.