Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 224-736-9 | CAS number: 4468-02-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 54.4 µg/L
- Assessment factor:
- 1
- Extrapolation method:
- assessment factor
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 42.5 µg/L
- Assessment factor:
- 1
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 362.4 µg/L
- Assessment factor:
- 100
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 341.5 mg/kg sediment dw
- Assessment factor:
- 1
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 188.9 mg/kg sediment dw
- Assessment factor:
- 1
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 181.2 mg/kg soil dw
- Assessment factor:
- 1
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
For deriving PNEC, care was taken because of the ionisable organo-metallic property of the substance, as results could express different toxicities. As outlined by the technical guidance of ECHA, acute test does not provide a complete measure of toxicity for such substances. Consequently, PNEC are based on the PNEC derived in the EU RAR documents on Zinc metal zinc sulphate and zinc chloride.
In the EU RAR documents, PNEC value are derived taking into account several studies based on zinc acute and chronic toxicity and taking into account the environmental fate and pathways. In order to establish a complete classification with the more relevant and reliable data, the EU RAR documents (cf. references) on zinc sulphate and zinc metal were used, as a continuation of the read-across approach used.
The value of PNEC are presented in the following table:
Environmental compartment |
PNEC value, as Zn (dissolved zinc) |
Freshwater (Hardness > 24 mg/L, as CaCO3) |
7.8 μg/l |
Freshwater (Hardness <24 mg/L, as CaCO3) |
3.1 μg/l |
Freshwater sediment |
49 mg/kg dwt 11 mg/kg wwt |
STP effluent |
52 μg/l |
Soil |
26 mg/kg dwt 23 mg/kg wwt |
For applying the in the risk assessment of zinc digluconate, these value are converted using the molecular weight of zinc (MZn=65.39) and zinc digluconate (MZn-Glc=455.682). The following values are selected:
Environmental compartment |
PNEC value, as Zn (dissolved zinc) |
Freshwater (Hardness > 24 mg/L, as CaCO3) |
54,4 μg/l |
Freshwater (Hardness <24 mg/L, as CaCO3) |
21,6 μg/l |
Freshwater sediment |
341,5 mg/kg dwt 76,7 mg/kg wwt |
STP effluent |
362,4 μg/l |
Soil |
181,2 mg/kg dwt 160,3 mg/kg wwt |
Ref:
European Union Risk Assessment Report ZINC METAL, 2010 (EUR 24587 EN – 2010)
European Union Risk Assessment Report ZINC SULPHATE, May 2008 (R076_0805_env)
European Union Risk Assessment Report ZINC CHLORIDE, May 2008 (R075_0805_env)
Conclusion on classification
Acute aquatic toxicity:
The following key values for chemical safety assessment were selected:
Taxonomic groups |
“Species mean” NOEC values (μg/l) |
Fish |
EC-96h = 11.12 mg/L |
crustacea |
EC50-48h = 22.8 mg/L |
algae or other aquatic plants |
EC50 -72h = 0.26 mg/L |
Considering that:
- 96 hr LC50 (for fish) > 1 mg/l
- 48 hr EC50 (for crustacea) > 1 mg/l
- 72 or 96 hr ErC50 (for algae or other aquatic plants) < 1 mg/l (determined at 0.26mg/l)
the substance is classified as Category 1 regarding acute aquatic toxicity to the environment.
The M Factor is set according to the table 4.1.3 of the annex I of CLP regulation. The EC50 value used is included in the following interval : 0,1 < L(E)C50 ≤ 1. Consequently the corresponding M factor is 1.
Chronic aquatic toxicity:
Since the REACH registration dossier submitted have been made in view of 10-100T/y, no chronic data were reported. In order to establish a complete classification with the more relevant and reliable data, the EU RAR documents (cf. references) on zinc sulphate, zinc chloride and zinc metal were used, as a continuation of the read-across approach used.
According to Annex I: 4.1.1.2.2 of CLP regulation, “both freshwater and marine species toxicity data are considered suitable for use in classification provided the test methods used are equivalent.” Therefore, the main value used and summarized in the EU RAR document (zinc metal) for fresh and marine water are reported in the two tables below:
Table 1 - Species mean” NOEC values that are used as input values for deriving the 5th percentile values as a basis for the freshwater PNECaquaticin the EU RAR documents.
Taxonomic groups (freshwater) |
“Species mean” NOEC values (μg/l) |
Algae (unicellular) |
17 |
Algae (multicellular) |
60 |
Poriferans |
43; 43; 43; 65 |
Molluscs |
75; 400 |
Crustaceans |
37; 42; 88 |
Insects |
137 |
Fish |
44; 50; 78; 189; 530; 660 |
Table 2 - “Species mean” NOEC values that are used as input values for deriving the 5th percentile values as a basis for the saltwater PNECaquaticin the EU RAR documents.
Taxonomic groups (marine water) |
“Species mean” NOEC values (μg/l) |
Algae (unicellular) |
10; 10; 10, 15; 15; 20; 32; 100; 100; 100; 140; 200; 500; 2700 |
Algae (multicellular) |
100 |
Coelenterates |
300 |
Annelids |
100; 100; 100; 320 |
Molluscs |
19; 50; 50; 1000 |
Crustaceans |
18; 120; 440 |
Echinoderms |
10 |
Considering the most sensitive specie during chronic exposure, as presented in the tables above (algae unicellular or Echinoderms), the NOEC used for classification is stated as 10 µg/L (or 0.01mg/L).
Considering that the substance is rapidly biodegradable, and according to the table 4.1.0 of the annex I of CLP regulation, the substance should be considered as classified in the Category Chronic 1 since Chronic NOEC (for algae or other aquatic plants)£0,01 mg/l.
The M Factor is set according to the table 4.1.3 of the annex I of CLP regulation. The NOEC value used is included in the following interval: 0,001 < NOEC ≤ 0,01. Consequently, the corresponding M factor for rapidly degradable substance is 1.
Finally, the classification considered for Chronic aquatic toxicity is the following: Category Chronic 1 (H410) ; M factor = 1.
Refrences:
European Union Risk Assessment Report ZINC METAL, 2010 (EUR 24587 EN – 2010)
European Union Risk Assessment Report ZINC SULPHATE, May 2008 (R076_0805_env)
European Union Risk Assessment Report ZINC CHLORIDE, May 2008 (R075_0805_env)
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.