Registration Dossier

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Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
7.1 µg/L
Assessment factor:
1
Extrapolation method:
sensitivity distribution
PNEC freshwater (intermittent releases):
0 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
8.6 µg/L
Assessment factor:
2
Extrapolation method:
sensitivity distribution
PNEC marine water (intermittent releases):
0 µg/L

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
0.33 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
109 mg/kg sediment dw
Assessment factor:
1
Extrapolation method:
sensitivity distribution

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
109 mg/kg sediment dw
Assessment factor:
1
Extrapolation method:
sensitivity distribution

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
29.9 mg/kg soil dw
Assessment factor:
2
Extrapolation method:
sensitivity distribution

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
0.12 mg/kg food
Assessment factor:
10

Additional information

The approach for deriving PNEC values was used in the 2008/2009 European Union Existing Substances Risk Assessment of Nickel (EU RAR) (EEC 793/93). The EU RAR was jointly prepared by the Danish Environmental Protection Agency (DEPA), which served as the Rapporteur of the Existing Substances Risk Assessment of Nickel, and the Nickel Producers Environmental Research Association (NiPERA), which represented the Nickel Industry in this process. The complete Environment section of the EU RAR can be found in the pdf linked to the following URL:

 http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing-Chemicals/RISK_ASSESSMENT/REPORT/nickelreport311.pdf

 

All of the approaches described were discussed by the Technical Committee for New and Existing Substances (TC NES), and received final approval at the TC NES I meeting in April, 2008.

 

Procedure for considering new data in the nickel ERVs and PNECs used for environmental hazard

A comprehensive literature review is conducted annually using PUBMED and Web of Science scientific databases (which cover searches in TOXNET, Toxline, BIOSIS, and DART databases). “Nickel” is used as a broad search term, as well as terms from section titles in the IUCLID database template for Section 5 (Environmental Fate) and Section 6 (Ecotoxicology). The substance identifier synonyms include nickel, nickel ion, nickel (2+) and Ni2+. Study inclusion was limited to publications in English (or that have an abstract in English at a minimum).

Reliability scoring is based on the systematic approach for evaluating the quality of experimental ecotoxicological data. These criteria were developed by the Nickel Institute based on the Environment section of the European Union’s Existing Substances Risk Assessment of Nickel, which assessed the risk associated with the ongoing use of nickel metal, nickel chloride, nickel sulphate, and nickel dinitrate. The guidance used in the risk assessment was developed in parallel with the Metals Environmental Risk Assessment Guidance (MERAG), which sought to provide metal-specific risk assessment guidance as a supplement to the EU’s Technical Guidance Document (TGD) that was established mainly on principles developed for organic substances.

The assessment of data adequacy involves a review of individual data elements with respect to how the study is conducted and how the results are interpreted in order to score the study. The term “adequacy” covers both the reliability of the available data and the relevance of the data to assess the ecotoxicity of the substance.

New Environmental Fate and Ecotoxicity data are reviewed in the context of existing Ecotoxicity Reference Values (ERVs) and Predicted No-Effects Concentrations (PNECs). ERVs and PNECs were established in conjunction with the Danish Rapporteur during the Existing Substances Risk Assessment of nickel in 2008. New data are evaluated to ensure that they fit within the boundaries of the ranges for the existing ERVs and PNECs. Any newly identified data falling outside of the identified endpoint ranges are evaluated to ensure that their inclusion in the REACH dossier will not impact the existing ERVs or PNECs. A full evaluation and recalculation of the nickel ERVs will occur in 2020. An examination of the nickel PNECs is scheduled for 2021.    

Common effects assessment basis:

 The ecotoxicity databases on the effects of soluble nickel compounds to aquatic, soil- and sediment-dwelling organisms are extensive. It should be noted that the effects assessments of Nickel metal is based on the assumption that adverse effects to aquatic, soil- and sediment-dwelling organisms are a consequence of exposure to the bioavailable Ni-ion, as opposed to the parent substances. The result of this assumption is that the ecotoxicology will be similar for all soluble Ni substances used in the ecotoxicity experiments. Therefore, data from soluble nickel substances are used in the derivation of chronic ecotoxicological NOEC and L(E)C10 values. If both NOEC and L(E)C10 data are available for a given species, the L(E)C10 value was used in the effects assessment.

Read-across justification is provided as an attachment (see Information panel)

Conclusion on classification

Classification of Nickel Metal Massive and Nickel Metal Powder

 

Guidance on the Application of the CLP Criteria section IV.5.5 states that “Normally, the classification data generated would have used the smallest particle size marketed to determine the extent of transformation. There may be cases where data generated for a particular metal powder are not considered as suitable for classification of the massive forms. For example,

 

·       where it can be shown that the tested powder is structurally a different material (e.g. different crystallographic structure) and/or

·       it has been produced by a special process and is not generally generated from the massive metal,

classification of the massive can be based on testing of a more representative particle size or surface area, if such data are available. The powder may be classified separately based on the data generated on the powder.

 

Nickel metal powder is manufactured in the EU by special processes (e.g. pyrolysis, atomisation, hydrogen reduction) and is not generally generated from the massive metal e.g. by mechanical processes such as filing or grinding. Hence, for nickel metal, separate environmental classifications for massive and powder forms are warranted. 

In 2003, a study was conducted to assess the production of fines from the normal handling and use of nickel massives. A protocol for measuring the generation of fines from massives (see Appendix A5) was developed to outline a procedure to determine the percentage (and resulting volume) of fines generated in the normal handling and use (including transportation, storage, movement, and emptying of containers) of massive forms of nickel metal. The study was conducted and data were collected from 7 nickel producing companies. The results are reported below. The results of the study shows that nickel metal in powder form is not generally generated from the massive form.

 

Nickel Metal Product

Measured data for fines produced from normal handling and use of massives

[average fines as % of massives]

Briquettes

0.2% (0.03-0.4%)

Masses

0.0004% (0.0001-0.001%)

Total

0.1% (0.0001-0.4%)

 

Nickel metal massive was assigned no classification for aquatic toxicity based on comparison of the transformation/dissolution data for nickel metal granules with the acute and chronic ecotoxicity reference values (ERVs) for soluble nickel, in accordance with the aquatic toxicity classification schemes for metals and metal compounds described in European Union (EU) and United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) (United Nations, 2003). Since the transformation/dissolution values were less than the acute and chronic ERVs no classification for aquatic toxicity of nickel metal massives was appropriate. This is consistent with the CLP harmonized classification for nickel metal massives for the environment.

 

 

Derivation of the Classificationof nickel metal powder

 

The aquatic toxicity classification for nickel metal powder can be derived by comparing the transformation/dissolution data for nickel metal powder with the acute and chronic toxicity reference values for soluble nickel compounds. This approach is outlined in the classification schemes for metals and metal compounds described in European Union (EU) and United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) (United Nations, 2003).

 

Transformation-Dissolution Data

 

Acute (7 day) and chronic (28 day) transformation/dissolution (T/D) data for nickel metal powder were collected. 7 d T/D P tests included testing at 1, 10, and 100 mg/L loading rates, whereas 28 d T/D P testing was performed at the 1 mg/L loading rate. All duration/loading rates were performed at both pH 6 and 8. 

 

 

Acute Toxicity Reference Value

 

In order to assess acute toxicity classification, low and high pH acute toxicity reference values are needed to compare to the existing T/D data at pH 6 and 8, respectively. 

 

Acute Ecotoxicity Reference Values were updated in 2021 to include appropriate data available through 2020. The acute ecotoxicity reference value chosen for high pH was 0.146 mg Ni/L, which is the geometric mean of the available Ceriodaphnia dubia ecotoxicity (LC50) values in the pH range of 7.5-8.5. The acute ecotoxicity reference value at pH 6 (pH range 5.5-6.5) is .286 mg Ni/L for the alga Pseudokirchneriella subcapitata. 

 

Belanger and Cherry (1990) reported that reproduction and mortality of Ceriodaphnia dubia was not impaired between pH 6.14 and 8.99, but reproduction became significantly impaired beyond these boundaries. As a consequence, pH could be a confounding factor for the adverse effects that were noted at pH 6. Based on these arguments, it was decided that no species-specific ecotoxicity reference value at pH 6 for C. dubia should be considered.

 

 

Chronic Toxicity Reference Value

 

In order to assess acute toxicity classification, low and high pH chronic toxicity reference values are needed to compare to the existing T/D data at pH 6 and 8, respectively. 

 

Chronic Ecotoxicity Reference Values were updated in 2021 to include appropriate data available through 2020. The chronic ecotoxicity reference value chosen for high pH was 0.006 mg Ni/L, which is the geometric mean of the available Ceriodaphnia dubia ecotoxicity (EC10) values in the pH range of 7.5-8.5. The chronic ecotoxicity reference value at pH 6 is 0.023 mg Ni/L for Daphnia magna.

 

Belanger and Cherry (1990) reported that reproduction and mortality of Ceriodaphnia dubiawas not impaired between pH 6.14 and 8.99, but reproduction became significantly impaired beyond these boundaries. As a consequence, pH could be a confounding factor for the adverse effects that were noted at pH 6. Based on these arguments, it was decided that no species-specific ecotoxicity reference value at pH 6 for C. dubia should be considered.

 

 

Aquatic Toxicity Classification

 

Aquatic toxicity classification can be assigned to a nickel sample by comparing the transformation/dissolution (T/D) results with the acute and chronic toxicity reference values for similar conditions using the EU and GHS classification schemes for metals and metal compounds.

 

For 7 day Ni metal powder T/D P data, the only loading rate at which dissolved Ni concentrations exceeded the acute ERVs was at 100 mg/L. Dissolution of 100 mg/L @ pH 6 was 0.35 mg/L, which exceeded the pH 6 ERV of 0.286 mg/L (dissolution of 10 mg/L @pH 6 was 0.024 mg/L). Likewise, dissolution of 100 mg/L @ pH 8 was 0.28 mg/L, which exceeded the pH 8 ERV of 0.146 mg/L (dissolution of 10 mg/L @ pH 8 was 0.029 mg/L). 

 

For the 28 d test using 1 mg/L loading, dissolution was 0.0023 mg/L at pH 6, and 0.0035 mg/L at pH 8. The pH 6 dissolution of 0.0023 mg/L did not exceed the chronic pH 6 ERV of 0.023 mg/L. The pH 8 dissolution of 0.0035 mg/L did not exceed the chronic pH 8 ERV of 0.006 mg/L.

 

Critical Surface Area (CSA) Approach

 

An alternative approach to deriving the classification of R52-53 for nickel metal powder is the Critical Surface Area (CSA) Approach, described by Skeaff et al. (2000) and the MERAG (Metal Environmental Risk Assessment Guideline) fact sheet on classification (MERAG 2007), as well as referred to in the GHS under paragraph A8.7.5.4.4 (United Nations, 2003). The CSA Approach utilizes both the transformation/dissolution data and toxicity reference values to determine acute and chronic classification, as does the current EU and GHS classification systems, but the CSA Approach enables determination of classification based on surface area and equivalent spherical particle diameters. 

 

 

Acute Toxicity: 

 

The CSA Approach can be used to assign an acute classification to nickel metal powder based on measured surface area using the measured surface area of 0.43 m2/g for the smallest representative size powder on the EU market. Since this surface area is greater than 0.1 m2/g but less than 1 m2/g, the acute classification for nickel metal powder would be R52. The CSA Approach can also be used to classify nickel metal massive, where the measured surface area of the CERAC granules[1](representative of nickel massives) is 0.086 m2/g. This surface area is less than all of the SAcrit so there would be no acute classification for nickel metal massive. These acute classification conclusions for nickel metal powder and massive are consistent with the EU and GHS classification approaches described above.

 

Chronic Toxicity: 

 

The CSA Approach can be used to assign a chronic classification to nickel metal powder based on measured surface area using the measured surface area of 0.43 m2/g for the smallest representative size powder on the EU market. Since this surface area is greater than 0.342 m2/g, nickel metal powder would be classified as R53. The CSA Approach can also be used to classify nickel metal massive, where the measured surface area of the CERAC granules[1] (representative of nickel massives) is 0.086 m2/g. This surface area is less than the chronic SAcrit so there would be no chronic classification for nickel metal massive. These chronic classification conclusions for nickel metal powder and massive are consistent with the EU and GHS classification approaches described above.

 

Conclusions

 

Nickel metal powder is classified as Aquatic Chronic III in the 1st ATP to the CLP Regulation.

 

Nickel metal powder including a Nickel oxide impurity should also be classified as Aquatic Chronic III in the EU GHS classification system.  No change to the Environmental Classification will result from the Nickel oxide impurity because Nickel oxide is classified as Aquatic Chronic IV in the 1st ATP to the CLP Regulation, which is less stringent than the classification for Nickel metal powder. 

 

Nickel metal massive are not classified in the EU DSD or EU GHS aquatic classification systems for metals and metal compounds based on transformation/dissolution data for nickel metal massive being less than the acute and chronic ERVs.

Environmental Transformation and Removal

 

The 2nd ATP to the CLP introduced the chronic (long-term) environmental toxicity endpoint as defined by the 3rd version of the UN-GHS into the EU hazard classification and labeling scheme. The GHS and EU scheme include the concept of degradation whereby rapid degradation from the water column (greater than 70 % removal in 28 days) results in different classification cut-off values and categories.  For metals and inorganic metal compounds, the rapid and irreversible removal from the water column is equated to the rapid degradation concept for organics.  The current draft guidance on metals includes a proposal to apply the “rapid degradation principle for organics” measured as a 70 % removal rate in 28 days in a comparable way for metals from laboratory and field experiments or by using a recently developed model.

 

A weight of evidence approach was developed to address the unique properties of metals in the context of hazard classification (Burton et al., 2019). This approach includes the development and application of an extension of the previously developed Transformation and Dissolution Protocol (i.e., the T/DP-E) to assess to assess the “degradability” of metals in terms of environmental transformation and removal. The weight of evidence approach also includes consideration of intrinsic properties, field data, laboratory studies (not necessarily related to the T/DP), and modeling analyses.

 

There has been considerable research on physical and chemical processes that determine the bioavailability and fate of nickel and other metals in surface water and sediment. Decades of research on metal speciation and partitioning behavior has supplied quantitative and mechanistic descriptions of their interactions with natural particles which scavenge them from the water column. The affinity of nickel and other metals for the various functional groups present on environmental particles varies in a predictable way based on their intrinsic properties. The interaction between metals such as nickel and ligands (both in solution and on the surface of particulate matter) involves breaking and making chemical bonds and has been shown to influence their bioavailability. There is an abundance of evidence to support sediment as the ultimate repository of nickel and other metals. In sediment, sulfides, iron (hydr)oxides, and manganese oxides remove nickel and other metals from pore water via precipitation and/or sorption, thereby decreasing their solubility and bioavailability.

Field investigations of nickel fate in whole-lake experiments or large-scale surveys are less prevalent than for other metals (e.g., copper). However, there is evidence in estuaries and a lake that nickel is removed from the water column. Mass balance inventories for nickel in several estuaries (Forth, Gironde, Scheldt, and the Gulf of St. Lawrence) indicate that much of it is removed from the water column and retained within the estuary itself as opposed to being transported out. Available data from Costello et al. (2016) and Topping et al. (2001) provide insight into the behavior of nickel in sediments. Soon after its introduction into a sediment, nickel pore water concentrations and the potential for toxicity decline (Costello et al., 2016). While the nickel flux may be directed out of the sediment in some cases, it is possible that the associated impacts to the water column are not substantial nor result in concentrations above regulatory levels as was the case for the locations sampled in San Francisco Bay (Topping et al., 2001; Yee et al., 2007).

 

Laboratory and modeling studies provide additional insight into nickel removal from the water column. The simple need to replenish nickel in microcosm studies with a frequency on the time-scale of days provides evidence that removal occurs relatively rapidly. The T/DP-E experiments demonstrate that 70% removal of nickel within 28 days was achieved in many experiments where this was used as a metric for environmental transformation and removal. Substantial nickel remobilization was not observed following resuspension of settled particles in T/DP-E experiments. The rate/extent of nickel removal was influenced by the characteristics and amount of the substrate used in the laboratory tests. Assessment of nickel removal in a generalized lake using state-of-the-art chemical speciation models within the TICKET-UWM indicated that 70% removal of nickel in 28 days occurs at different water pH values and with different loadings. Furthermore, feedback from sediment did not interfere with attainment of low nickel concentrations in the water column of the model. 

 

Overall, the evidence examined in this report supports the conclusion that nickel, like many other metals, has a large affinity for particles in the natural environment and is removed to a large extent from the water column of field-scale systems such as lakes, rivers, and estuaries; laboratory-scale systems such as the T/DP-E; and model systems such as the TICKET-UWM generalized lake. Furthermore, field, laboratory, and modeling data assessed in this report do not indicate substantial impacts to the water column due to nickel remobilization from sediment.

 


[1]The nickel sample used to classify nickel metal massive as no classification for aquatic toxicity was a sub-sample of nickel metal CERAC N-1021 that was sifted to a mesh size of 710-850 µm. The measured surface area of this sample was 0.086 m2/g.