Nickel Forum

2000-01

NiPERA project

Atmospheric Monitoring of Urban Air Toxics

National Air Urban Toxics Research Center (NUATRC), (TX, USA)

To understand health risks associated with exposure to particulate matter.

Some of the studies examine the role of metals in cardiovascular and respiratory disease associated with inhalation of PM 10 and PM 1

2004

2000-06/2000-07

NiPERA project

In Vitro Evaluation of Relative Genotoxic Potential of Well Characterized Nickel Samples

J. Landolph/University of Southern California (CA, USA), Particle Technology (OH, USA)

To establish relative genotoxicity of various compounds of interest to NiPERA

Examine influence of particle size, shape, surface area, etc

For those compounds for which no animal or human data exist, the results from these studies can help us predict their behaviour relative to well characterized compounds.

Completed

2003--09

In vivo Micronucleus Study in Rats

G. Erexson/Covance Laboratory

To determine the mutagenic potential of soluble nickel in vivo

Results from this research could impact mutagenicity classification, mode of action and risk characterization

Completed

2002-09

NiPERA project

In Vitro Evaluation of Relative Genotoxic Potential of Workplace Samples

J. Landolph/University of Southern California (CA, USA), Particle Technology (OH, USA)

To establish relative genotoxicity of real world dust samples compared to well-characterized single compounds

Results from this research can help us understand the relevance of testing individual compounds in animal studies as surrogate for workplace exposures.

March 2004

2001-01

NiPERA project

Reproductive Epidemiologic Study in the Kola Peninsula

E. Niebor/McMaster University (Canada) and colleagues in Norway & Russia

To determine whether women employed in the refining of sulphidic ores in Russia have increased rate of adverse reproductive effects. Occupational and lifestyle exposures will be correlated to outcomes.

Animal studies in rats have demonstrated that high oral exposures to nickel sulphate hexahydrate can result in adverse reproductive effects. Based on these results, a Category 2 Reproductive Toxicant classification is recommended by the Danish EPA.  This study will assess whether the animal results are relevant to humans. 

Dec 2004 (one year extension from previous completion date)

BK Tox Fund Project

Inhalation Carcinogenicity Study with Nickel Metal Powder: 28-day, 90 day, 32 month studies

D. Kirkpatrick/ WIL Research Laboratory (OH, USA)

Establish respiratory carcinogenic potential of elemental nickel powder via inhalation

There are no well-conducted inhalation studies with nickel metal powder. The Danish EPA is proposing a Category 3 carcinogen classification for nickel metal based on injection studies.  This study will provide guideline compliant data by relevant route of exposure..

28-D complete

90-D complete

30-Month:

Start inlife:  Mar-04

End inlife:  Aug-06

Histopath:  May-07

Draft Rept:  Aug-07

Final Rept:  Oct-07

Existing Substances Fund Project

IUCLID

J. Wirtz – Parametrix, Inc. (USA)

Provide Denmark with IUCLID dataset on the priority-listed Ni substances.

Required for risk assessment.

Completed

2001-02

NiPERA project

Induction of Immunological Tolerance to Nickel

Gleichmann/Heinrich Heine University, Duesseldorf (Germany)

To characterize the immune cells and cytokines involved in the induction and effector phases of hypersensitivity to nickel.

This study will improve understanding of risks and benefits of oral intake of nickel regarding nickel allergy.

April, 2004

Existing Substances Fund Project

Dermal Nickel Exposure in Nickel Refining

Aiken/IOM (UK)

Quantify dermal exposure to nickel and nickel compounds in nickel-producing and using workplaces

This study will provide data for assessing dermal exposure in various workplace scenarios

February 2005

20001-11

NiPERA project

Measurement of Dermal Ni Exposure in Different Occupational  Settings

Gawkrodger/University of Sheffield (U.K.)

Measure levels of dermal nickel exposure in several workplaces

This study will provide data for assessing dermal exposure in nickel production and consumer use areas.

February 2004

2002-01

NiPERA project

Contact Dermatitis Provoked by Oral Exposure to Nickel

Menné/Gentofte Hospital (Denmark)

Evaluate existing data on oral elicitation of nickel dermatitis; identify an oral threshold level of nickel-allergic reaction

This study will provide data on which to base an oral elicitation threshold for nickel allergy.

Completed

2000-02

NiPERA project

Literature Review on the Safety of Metal Implants

Hildebrand/ Institut de Médicine du Travail (France)

Conduct a literature review on the carcinogenicity and sensitization issues related to the use of metal implants

This study will provide information on health effects of nickel-containing implant for use in the risk assessment.

March 2004

2001-07

NiPERA project

Rat Two Year Cancer Bioassay by Oral Exposure to NiSO₄×6H₂)

Springborn Laboratories (USA)

Determine the carcinogenicity of nickel sulphate hexahydrate in rats following oral exposure.

This study will provide guideline compliant  data with regard to the carcinogenic potential of orally-administered soluble nickel in rodents.

March 2005

Existing Substances Fund Project

Dustiness of Nickel and Nickel Compounds Testing

EBRC (Germany)

Determine similarity in dustiness between Zn, ZnO, Ni, NiCl₂, NiSO₄, and NiCO₃(OH)₂ to

This study will facilitate extrapolation between occupational exposure scenarios for substances of similar dustiness results.

June 2004

Existing Substances Fund Project

Nickel ion release form nickel powder in synthetic sweat

KTH (Sweden)

Determine the amount of  nickel ions released from nickel powder when immersed in synthetic sweat over a length of time comparable to occupational exposure

This study will provide data for comparison of nickel metal exposure data to the soluble nickel elicitation threshold for risk assessment

April 2004

Existing Substances Fund Project

In vivo oral toxicokinetics in rats of massive nickel metal (i.e., ~1mm particles)

Wil Laboratories, Ashland

After oral exposure to ~1mm nickel metal, determine the blood level of nickel ion at the maximum Tolerated Dose (MTD) to compare against soluble nickel blood levels at the reproductive NOAEL

Will determine whether metallic nickel massives need to carry any reproductive classification

June 2004