Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
12.2 mg/L
Assessment factor:
100

Sediment (freshwater)

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Sediment (marine water)

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

A comparison of existing acute and chronic data across (spanning several classes: dialkyl peroxides, diacyl peroxides, peroxymonocarbonates, hydroperoxides, ketone peroxides, peroxydicarbonates, peroxyketals and peroxyesters) was made for several organic peroxides belonging to the consortium, and this is summarised in the attached position paper.

The results were as follows:

Acute to chronic ratios, based on comparison of acute data with EC10 values

Algae: 3.2

Daphnia: 5.3

Fish: 1.9

Based on the acute data, a species sensitivity analysis indicated that algae are almost always the most sensitive species or as sensitive for short term studies to organic peroxides.

As an outcome of this analysis, the following was concluded:

A factor of 100 or more difference between acute to chronic toxicity is applied with an extra factor of 10 for species sensitivity. In this case, we considered that the short-term to long-term toxicity extrapolation uncertainty is greatly reduced, both for ACR and for species sensitivity and a factor of 100 would be largely sufficient.

Conclusion on classification

No effects were found short-term or long-term at the water solubility limit; acute endpoints were all greater than 100 mg/L loading and in a Daphnia reproduction study no effect was seen at the water solubility limit.

From a ready biodegradability study it can be concluded that the substance is readily biodegradable.

Dihexadecyl peroxodicarbonate is practically insoluble in water and has a very high estimated log Kow of 15.5 it is readily biodegradable and instable and is therefore considered not to bioaccumulate very easily.

These findings show that under Directive (67/548/EEC) and Regulation (EU) No 286/2011 (2nd ATP to CLP) Dihexadecyl peroxodicarbonate does not need environmental classification.