Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.56 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
5.6 µg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
6.16 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:
88.8 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The PNEC values were determined for the substance itself by application of methods provided in ECHA Guidance Chapter R.10 (May 2008).

Conclusion on classification

The substance is an organometallic substance which contains zinc moiety. It is readily soluble in water at loading =< 100 mg/L.

The short-term toxicity of the registered substance to aquatic organisms was investigated according to OECD TG 201 and compliant with GLP and by a read-across apporach. The following toxicity values are available for the substance:

Fish Acute: 96h-LC50 = 96.73 mg/L

Aquatic invertebrates: 48h-EC50 = 8.61 mg/L

Algae: 72h-ErC50 = 0.56 mg/L

The lowest acute aquatic toxicity values based on available data ranges between 0.1 and 1.0 mg/L. The long-term toxicity of registered substance to aquatic organisms was not investigated. Thus, there are no adequate chronic toxicity data available.

The degradation of the substance was investigated according to OECD Guidelines:

A reliable study carried out according to OECD Guideline 301F and GLP compliant is available on registered substance. Under the conditions of this study, the registered substance was found readily biodegradable (92% of biodegradation at Day 28 based on O2 consumption). Therefore, the substance is considered as rapidly degradable in aquatic system.

Information on bioaccumulation potential of the submission substance:

No fish BCF is available. Experimental Log Kow is below 3.0 which a low potential for bioaccumulation.

CLP Classification proposal

It is proposed to compare submission substance dataset to CLP environmental criteria laid down in CLP Regulation (including 2nd Adaptation to Technical Progress, Com Reg No 286/2011).

Acute aquatic hazard: Category 1. Reasoning: lowest E(L) C50 between 0.1 and 1.0 mg/L.

Chronic aquatic hazard: Not classified. Reasoning: no long term toxicity data available, readily soluble and rapidly degradable with Log Kow < 3.

DSD Classification proposal

N; R50. Reasoning: lowest acute E(L) C50 value range between 0.1 and 1.0 mg/L, readily biodegradable substance with Log Kow < 3.