[No public or meaningful name is available]

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

100 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Conclusion on classification

Classification

Based on all available ecotoxicological data for daphnids, fish and algae, NX 8000J does not need to be labelled according to Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 since at the maximum attainable concentration no toxicity was observed and the measured BCF values are below 500.

Preliminary PBT assessment

An assessment of the PBT status of NX 8000J has been made using all available data. The information available suggests that NX 8000J does not meet the PBT screening criteria as outlined in Directive 2006/121/EC.

Persistence

A CO₂evolution test (OECD 301B) showed that NX8000 is not readily biodegradable; NX 8000J is therefore identified as being potentially persistent.

Bioaccumulation

A Flow-through fish test (OECD 305) showed that the bioconcentration factor is 150; NX 8000J is therefore considered not bioaccumulative.

Toxicity

The acute effect concentrations for all three trophic levels are much higher than the highest attainable test concentration (0.0015 mg/l). It can therefore be expected that difluoromethane is not potentially toxic towards aquatic organisms. NX 8000J is not classified as being CMR a carcinogenic and there is no evidence that NX 8000J is chronically toxic towards mammals. Therefore NX 8000J is not assigned as being toxic.

The overall conclusions, based on the present available data, of the preliminary PBT assessment are that the (screening) criteria for PBT/vPvB are not met and that further testing in the scope of the final PBT assessment is not considered to be required.