Registration Dossier

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.

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 by special processes (e.g., nickel carbonyl process, atomization, 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 nickel metal massive and nickel metal powder are warranted.  

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.

For nickel metal powder a position paper entitled “Aquatic Toxicity Classification of Nickel Metal Powder” was prepared by the Nickel Producers Environmental Research Association (NiPERA). The paper was discussed at the European Chemical Bureau’s Commission Working Group on the Classification and Labelling of Dangerous Substances, which took place on April 26-27, 2006. The recommended classification from the DK Rapporteur and the Working Group was the same as that of NiPERA.

 

The NiPERA position paper presents information that supports the aquatic classification of nickel metal powder (particle size diameter < 1 mm) asAcute III/Chronic IIIin the International UN GHS system and asN; R52/53in the EU DSD system. These are the classifications that have been reported in the 1st ATP to the CLP Regulation. Acute III/Chronic IIIin the International UN GHS system is equivalent to Chronic III in the European Union GHS system (CLP Regulation).  

 

The NiPERA paper specifically includes the following information:

 

  • Ecotoxicity data used to determine acute and chronic Ecotoxicity Reference Values (ERVs) of soluble Ni2+;
  • Results of Transformation/Dissolution Protocol (T/D P) testing with nickel metal powder;
  • Comparison of Ni dissolution from T/D P studies with relevant ERVs to determine the appropriate classification; and,
  • The use of the Critical Surface Approach to distinguish between Ni metal powder and Ni metal massive.

 

Derivation of the Classification for 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. The acute toxicity reference value chosen for high pH was 0.068 mg Ni/L [same value proposed by the Danish EPA in document ECBI/26/95 Add. 76], which is the geometric mean of the 6 Ceriodaphnia dubia ecotoxicity (LC50) values in the pH range of 8.3-8.7 and hardness range of 258-290 mg/L as CaCO3(Schubauer-Berigan et al. 1993; Parametrix 2005a; Parametrix 2005b).  

 

The lowest ecotoxicity value at pH 6, which is 0.012 mg Ni/L for the alga Pseudokirchneriella subcapitata (Deleebeecket al., 2004), was chosen as the ecotoxicity reference value for comparison of the T/D data at pH 6. 

 

 

Chronic Toxicity Reference Value

 

Currently, the EU DSD classification system uses the most sensitive NOEC/EC10value available as the chronic Ecotoxicity Reference Value. The chronic toxicity reference value was chosen to be the EC10of 0.0024 mg Ni/L calculated by Parametrix (2004) [same value proposed by the Danish EPA in document ECBI/26/95 Add. 76] since: this value was derived at a pH slightly higher (pH 8.4), but similar to that of the high pH T/D data (pH 8), the pH of the study was approximately at the high pH limit (pH 8.5) for chronic T/D testing, the hardness conditions are similar to that of the T/D medium at pH 8, and a calculated EC10is appropriate to use when the NOEC value was not measured (a less than value). 

 

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 0.12 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 0.068 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 8 dissolution of 0.0035 mg/L exceeded the chronic ERV of 0.0024 mg/L.

 

Based on these results, the appropriate classification is R52/53 in the EU DSD system,Acute III/Chronic III in the International GHS systemand Chronic III in the EU GHS system.

 

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 Skeaffet 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 theSAcritso 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 granules1(representative of nickel massives) is 0.086 m2/g. This surface area is less than the chronicSAcritso 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 should be classified as N; R52-53using the data presented above in the EU DSD classification system for metals and metal compounds. This is equivalent to a classification of Aquatic Chronic III in the EU GHS classification system, as classified in the 1stATP to the CLP Regulation.

 

Nickel metal powder including a Nickel oxide impurity should also be classified as N; R52-53in the EU DSD classification system and 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 1stATP 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.

The 2ndATP to the CLP introduced the chronic (long-term) environmental toxicity endpoint as defined by the 3rdversion 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 Unit World Model (UWM) has recently been developed specifically for metals, building on previous screening-level calculations that have been developed for organic contaminants, and is capable of assessing the fate and effects of chemicals by the simultaneous consideration of chemical partitioning, transport, reactivity, and bioavailability.  With regard to hazard assessment, the UWM is capable of assessing the removal of soluble metals from the water column resulting from sorption to particulate material, settling to the sediment compartment, and subsequent changes in speciation via precipitation by sulfides naturally present in the sediment compartment. 

 

The UWM was used to assess the rapid removal of a group metals (e.g., Ni, Cu, Pb, Zn, As, Al, Co) in a generalized lake environment resulting from metal removal from the water column and sequestration in sediment.  To estimate sorption by particulate matter in the water column, the UWM can use empirical, measured distribution coefficients (Kd), or the speciation module within the UWM (the Windermere Humic Aqueous Model, or WHAM) can calculate Kds. When an empirical Kd of log 4.42 was used, greater than 70% nickel removal was achieved in every loading and pH scenario. WHAM-based Kds tended to be substantially lower than empirical Kds, indicating that refinement of the WHAM approach was needed. To this end, the UWM was refined to accommodate an updated version of WHAM (WHAM 7). Additionally, the inorganic thermodynamic database used by WHAM to perform speciation calculations was updated because the previous version was found to be out of date and inaccurate. Analyses using WHAM7 and the revised inorganic thermodynamic database showed that greater than 70% nickel removal was achieved under the three pH scenarios with metal loadings at the acute and chronic ERVs at 28 days.  At the upper chronic cutoff value of 1 mg/L, rapid removal was achieved for pH 6 and 8 without oxide binding and for all three pH values with oxide binding.  Rapid removal was demonstrated at all pH values when loading was based on acute Ecotoxicity Reference Values (120 µg Ni/L at pH 6 and 68 µg Ni/L at pH 8) and chronic Ecotoxicity Reference Values (2.4 µg Ni/L) using calculated Kd values. Based on these results, nickel metal fulfills the criteria for rapid degradation for the environmental classification scheme in the 2ndATP to the CLP. 

For nickel, test data developed at CANMET Mining Laboratories and University of Michigan, as well as field and microcosm data developed at Fraunhofer Institute and Kent State University provide additional evidence that nickel is rapidly removed from the water column.  A paper outlining the supporting evidence is under development and will be included in a dossier update planned for 2021.