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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
2.5 µg/L
Assessment factor:
1
PNEC freshwater (intermittent releases):
2.5 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
2.5 µg/L
Assessment factor:
1

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
10

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
3.07 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
3.07 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.882 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
5 mg/kg food
Assessment factor:
300

Additional information

Freshwater, Marine Water Sediment and Soil PNEC Values

Freshwater and marine sediments and soil PNEC values were calculated starting with an acute aquatic toxicity value of 0.38 micrograms/L and using the equilibrium partitioning method (see ECHA Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.10).

The required partition coefficients, K, were obtained from the EUSES Program (Ver. 2.1) with the following inputs:

Molecular Weight = 306.45 g/mol.

Melting Point (measured) = -25°C

Boiling Point (measured) = 251°C

Vapor Pressure (measured) = 14 Pa at 25°C

Octanol-Water Partition Coefficient (estimated) > 6.2

According to a EU Method A.6 and OECD Guideline 105 study following GLP, the substance has a water solubility of <0.0000284 g/L at 20 deg C. Water solubility used = 1.07 micrograms/L (lowest value accepted by program)

Hazard for Predators / Secondary Poisoning

The starting point for the calculation of a PNEC oral value was a NOAEL of 150 mg/kg bw/day from a sub-acute oral toxicity study in the rat (see Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.10, Section R.10.8.2).

A NOECrat,food (kg/kgfood) is obtained from the following equation:

NOECrat,food = NOAELrat x CONVrat

CONVrat = 10 (body wt / daily food intake)

Therefore, NOECrat,food = 150 mg/kg bwt/d x 10 = 1500 mg/kgfood

An assessment factor of 300 was applied to this NOEC value to give the final PNECoral (see Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.10, Section R.10.8.2 and Table R.10-13).

PNECoral = 1500 / 300 = 5.0 mg/kgfood

Conclusion on classification

Although biodegradable, the subject material failed the 10 -day criterion for classification as readily biodegradable. Based on an estimated octabol water pertition coefficient > 6.2, there is also a concern for bioconcentration. This material is classified as a Aquatic Chromic 4 hazard (H413: may cause long lasting harmful effects to aquatic life) (Harmonized classification - Annex VI of Regulation (EC) No. 1272/2008 (CLP Regulation). It is also rated as a R53 (May cause long-lasting effects in the aquatic environment) (Annex I of Directive 67/548/EEC)