Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 37 µg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 14.75 µg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 3.7 µg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
- PNEC marine water (intermittent releases):
- 1.475 µg/L
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 1.33 mg/L
- Assessment factor:
- 1
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 0.199 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 19.9 µg/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:
- 18 µg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
Derivation of PNECs
The PNECs for the different compartments are calculated either by application of an assessment factor (PNEC freshwater, PNEC marine water, PNEC intermittent release and PNEC stp) or by using theequilibrium assumption method (PNEC sediment-freshwater, PNEC sediment-marine-water and PNEC soil). The PNEC air is not considered as relevant based on the chemical structure and intrinsic properties of the registered substance. Secondary exposure of mammals and birds is not expected, and since no adequate bird or mammalian data are available, the PNECsecondary poisoning is omitted. The utilized procedures are described in detail in the ECHA REACH Guidance of May 2008, Chapter R.10 ("Characterisation of dose [concentration]-response for environment").
Conclusion on classification
There is currently no data available for the target substance on toxicity towards aquatic organisms and aquatic microorganisms. However, there is data available for the source substances (zinc salts and Fe(Na)EDDHA). With regard to the data for zinc the hazard values were converted to the registered substance under consideration of the maximum percentage of zinc included in the substance. This data is used within the concept of a worst case weight-of-evidence approach to assess the toxicity of the target substance and has been used for the risk assessment to derive the PNECs. The following information has been accounted for risk assessment:
According to the LC/EC50 data derived from OECD guideline studies with the source substance Fe(Na)EDDHA, representing the organic part of the target substance Zn(Na2)EDDHA, it can be concluded that no toxicity towards aquatic organisms is triggered by this compound.
Taking into account the lowest acute LC/EC50 value found in literature for zinc compounds including ZnSO4 and ZnCl2, converted to the zinc moiety in the target substance an EC50 of = 1.475 mg/L for Chlorella sp. has been derived. Reliable chronic data has been provided in the dossier for the zinc moiety with regard to aquatic toxicity. The lowest chronic value IC10 of 28 µg Zn/L was obtained in the study with algae (Johnson, 2007) and ZnCl2. After correction to the overall Zn moiety in the target substance (7.5%) a chronic IC10 of 0.37 mg/L has been derived.
This approach was favorable as worst-case approach for the risk assessment and to derive robust PNECs, but it does not reflect the real hazard for the aquatic environment of the registered substance, as the Zn2+ is chelated to 85% (see explanation in IUCLID section 1.2 Composition) at alkaline or neutral pH. Thus leading to a minimal amount of Zn2+ available for dissolution or complexation with other condensates in aquatic environment (please also see IUCLID section 5.1.2 Hydrolysis). The total non-chelated Zn2+ amount is therefore calculated as 1.3% (0.15*7.5% = ~1.3%). Applying the mixture rule for classification to the Zinc amount of 1.3% a classification as Aquatic Chronic 3 (H412) is warranted according to Table 4.1.2 of Regulation (EC) No 1272/2008. Further testing on aquatic algae as most sensitive species is foreseen for the registered substance to underpin this conclusion.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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