Page 36 - CITDBooklet

Guide on the application of REACH Regulation

Data requirements under REACH are tonnage based

DATA REQUIREMENTS

CATEGORY 1-10 t/a CATEGORY 10-100 t/a CATEGORY 100-1000 t/a Category >1000 t/a

Annexure VII Annexure VIII Annexure IX Annexure X

Phys-Chem Data

State of substance at 20
and 101.3 kPa

Melting point /Freezing
point

Boiling point Same as Annexure VII. Additional data Same as Annexure IX.
Relative density No additional data Stability in organic sol- No additional data
Vapour pressure vents
Surface tension Dissociation constant
Water solubility Viscosity

Log POW

Flash point

Flammability

Explosive properties

Self-ignition Same as Annexure VII.
Oxidizing properties No additional data

Granulometry

CATEGORY 1-10 t/a CATEGORY 10-100 t/a CATEGORY 100-1000 t/a Category >1000 t/a

Annexure VII Annexure VIII Annexure IX Annexure X

Toxicological Data

Skin irritation/corrosion Additional Data Additional Data Additional Data
(in-vitro) Skin irritation (in vivo) Sub-chronic toxicity Reproduction toxicity
studies (90d)

Eye irritation (in vitro) Eye irritation (in vivo) Reproductive toxicity Developmental toxicity

Skin sensitization Mutagenicity Pre-natal developmental Carcinigenicity
toxicity

Mutagenicity (Ames test) -in vitro cytogenicity 2 generation reproduc-
(mammalian cells) tive toxicity

Acute toxicity -in vitro micronucleus
study

In vitro gene mutation

Acute toxicity (inhalation
& dermal)

Short term repeat dose
toxicity (28d)

Reproductive and devel-
opment toxicity

Toxico-kinetic behavior

Ecological Data

Aquatic toxicity Additional Data Additional Data Additional data
(Daphnia)

Growth inhibition (Algae) Short term fish toxicity Long term toxicity (Daph- Degradation - biotic
nia)

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