Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
4 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
2.7 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.4 µg/L
Assessment factor:
500
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:
61.9 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
6.2 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:
12.4 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
22.2 mg/kg food
Assessment factor:
90

Additional information

In a semi-static daphnia reproduction study (OECD 211) daphnids were exposed during 21 days at loading rates of 0, 0.46, 1.0, 2.2, 4.6 and 10 mg/L (WAF) to a close analogue of the substance (Ca-salt). Mean measured concentrations (based on the acid part) were NA, 0.0052, 0.17, 0.14, 0.20 and 0.28 mg/L. Effects on growth were reported at a loading rate of 2.2 mg/L. The NOEL for reproduction and mortality were 4.6 and 10 mg/L(expressed as loading rate). The starting concentration for risk assessment is 0.20 mg/L.

An Assessment factor of 50 is applied to derive the PNECwater based on the availability of the algae study and the daphnia reproduction study. Thus, PNECwater is 4 µg/L. For lacking the toxicity data for marine water organisms and AF of 500 is applied to derive PNECsaltwater. Thus, the PNECsaltwater is 0.4 µg/L. An AF of 100 is applied to derive PNECaqua (intermittent releases) based on the outcome of the acute studies, thus PNECaqua (intermittent release) is 2.7 µg/L.

The NOECmicro-organism was 100 mg/L based on the active sludge respiration inhibition test. AF of 10 is applied. Thus, the PNECstp is 10 mg/L.

As no tests on sediment dwelling organisms and terrestrial organisms is available, EPM is applied to derive PNECsed, PNECmarine-sed and PNECsoil. Based on the available Koc (Ksusp and Ksoil-water), water solubility, molecular weight and vapor pressure, the PNECsed, PNECmarine-sed and PNECsoil are 62, 6.2 and 12.4 mg/kg dw respectively according to guidance on information requirements and chemical safety assessment chapter R.10.: characterisation of dose[concentration]-response for environment.

The PNEC oral is derived based on the available 90 days repeated dose toxicity data, CONVrat of 20 kg bw*d/kg food is applied for and AF oral of 90 is applied. Thus, PNECoral is 22.2 mg/kg food.

For the VP of the substance is low (3.3E-05 Pa at 20 degree C), thus the very limited hazard for air is expected.

Conclusion on classification

In none of the acute aquatic toxicity tests performed on fish, daphnia and algae, an LC50 or EC50 could be achieved within limits of solubility. Thus, the L(E)C50 on all three trophic levels is considered above water solubility and no classification for acute aquatic toxicity is derived according to CLP (Regulation EC No 1272/2008) or DSD (Directive 67/548/EEC). The NOELR in the daphnia reproduction study is 4.6 mg/L (> 1.0 mg/L). The log of n-octanol/water partitioning coefficient was > 6.6 and the substance is not rapidly biodegradable. Based on these findings, the substance is also not classifiable for chronic aquatic toxicity according to CLP.