Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.66 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
16.6 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.17 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
16.6 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:
33.1 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Above demonstrated computations on the different PNECs all are based on the standard default factors given by ECHA's "Guidance on information requirements and chemical safety assessment Chapter R.10: Characterisation of dose [concentration]-response for environment" and "ECB - Technical Guidance on Risk Assessment, in support of Commission Directive 93/67/EEC on Risk Assessment for new notified substances, Commission Regulation (EC) No 1488/94 on Risk Assessment for existing substances, Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market, Part II".

All studies used for PNEC derivation were being conducted on the analogue source substance (refer to IUCLID section 13). The applicability of the read across approach has been confirmed by the registrant (see IUCLID section 13, "Assessment Reports").

Conclusion on classification

CLP classification:

With the 2nd amendment of the CLP regulation, results from aquatic long-term studies are to be preferred for classification for chronic aquatic toxicity.

At this point in time only the results from the algae toxicity study (which is a multi-generation study) can be used directly for chronic aquatic toxicity classification. With a NOEC of 0.48 mg/L for non-rapidly degradable substances the resulting classification is "Aquatic Chronic Category 2", H411 "Toxic to aquatic life with long lasting effects".

Above stated classification also is being confirmed when using the results of the acute fish toxicity study (LC50 = 1.66 mg/L, i.e. the most sensitive acute study) in combination with the fact that substance registered is not rapidly degradable.

DSD classification:

The most sensitive acute aquatic toxicity study was the study with fish, revealing an LC50 of 1.66 mg/L. In combination with the fact that substance registered is not rapidly degradable, the resulting classification is "Dangerous for the environment" N; R51/53, "Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment". The DSD classification fits to above stated CLP classification.