Toxicologists Recommend Changes to OECD Guidelines to Include Nanoparticles

Expert toxicologists from the OECD Working Party on Manufactured Nanomaterials (WPMN) have issued a report recommending that OECD guidelines be updated to better address the specific properties of manufactured nanomaterials.  The experts - about 50 scientists - met in October 2011 in the Netherlands specifically for "Inhalation Toxicity Testing for Nanomaterials" so their main focus was on inhalation toxicity.

The result was the report being issued now by OECD, which can be seen here.

The objective of the changes recommended to the inhalation toxicity guidelines was to better detect potential for harm from inhaled nanoparticles, specifically those engineered to be of nanoparticle size. Ideally the changes with assist researchers and regulators in understanding the unique properties created by the very small sizes of nanomaterials. These small sizes are especially important for inhalation exposures as they may allow materials to get further down into the lungs and possibly even cross the tissues into the bloodstream.

Updated QSAR Tools Made Available to Assess Chemicals

Quantitative Structure-Activity Relationships (QSAR) are computer based tools that allow the estimation of chemical properties and toxicity based on a chemical's structure rather than from doing animal testing.  QSARS, and their more qualitative cousins, SARs, are commonly used as screening tools to determine whether animal testing is needed.  They are routinely used by the USEPA to assess premanufacture notice (PMN) submissions for new chemicals, which generally have very little actual testing data included.  With the advent of REACH, the EU has also shifted to a greater acceptance of SARs and QSARs in lieu of actual laboratory testing.

To this end the European Chemicals Agency (ECHA) has made various QSAR tools developed by industry and governments available to companies registering chemicals under the REACH chemical registration law that went into force in 2007.  ECHA has now released an updated, Version 2.2, of the "OECD QSAR Toolbox" for "grouping chemicals into categories" and "to fill data gaps by read-across, trend analysis and to assess the (eco)toxicity hazards of chemicals."  The goal is to provide data for decision-making while reducing costs and unnecessary vertebrate animal testing.  According to ECHA, users of the QSAR Toolbox can:

• Identify analogues for a chemical, retrieve experimental results available for those analogues and fill data gaps by read-across or trend analysis;
• Categorise large inventories of chemicals according to mechanisms or modes of action;
• Fill data gaps for any chemical by using the library of (Q)SAR models;
• Evaluate the robustness of a potential analogue for read-across;
• Evaluate the appropriateness of a (Q)SAR model for filling a data gap for a particular target chemical;
• Build (Q)SAR models.

More information on the OECD QSAR Toolbox can be found here.

India Meets Criteria to Join OECD "Mutual Acceptance of Data" Program

India has now met all of the requirements to be accepted into the OECD Mutual Acceptance of Data (MAD) program.  It did so by demonstrating that it could successfully conduct health and safety testing under Good Laboratory Practices (GLPs), which is the standard for such testing in all thirty-four of the OECD countries (which includes EU countries, the US and Canada, among others).  The achievement allows Indian chemical manufacturers to conduct and provide single tests in support of their products in all OECD countries.  This makes it easier and less costly to enter the marketplace.

The achievement is important because OECD consists of mostly economically developed countries, and India joins Brazil, Singapore and South Africa as the only developing countries to meet the tough OECD standards.  Being able to enjoy the benefits of the MAD program will greatly enhance marketability.  MAD is the system in which the results of a set of health and safety studies can be submitted in support of a product, and acceptance by a rapporteur member state is deemed acceptance by all member states.

OECD issues report on the safety of nanotechnology

As I have reported in the past, there is a lot of interest by various regulatory and government bodies in trying to come up with the best way to ensure the safety of nanoscale materials in the market place.  The newest is a report issued by the Organization for Economic Cooperation and Development (OECD).

The report is available as a PDF document here.

Specifically the document "provides information on current/planned activities related to the safety of manufactured nanomaterials in OECD member and non-member countries that attended at the 7th meeting of OECD’s Working Party on Manufactured Nanomaterials (Paris France, 7-9 July 2010)."  It also includes "written reports on relevant current activities in other International Organisations such as the ISO and the WHO."

The WHO (not the rock group) is the World Health Organization.  ISO is the International Organization for Standardization. Also contributing is the Food and Agriculture Organization (FAO; governments and scientists just love acronyms).

OECD's activities on nanotechnology are coordinated through "The Working Party on Manufactured Nanomaterials," which "brings together more than 100 experts from governments and other stakeholders"

According to the OECD report "The Working Party is implementing its work through specific projects to further develop appropriate methods and strategies to help ensure human health and environmental safety:

• OECD Database on Manufactured Nanomaterials to Inform and Analyse EHS Research Activities;

• Safety Testing of a Representative Set of Manufactured Nanomaterials;

• Manufactured Nanomaterials and Test Guidelines;

• Co-operation on Voluntary Schemes and Regulatory Programmes;

• Co-operation on Risk Assessment;

• The role of Alternative Methods in Nanotoxicology;

• Exposure Measurement and Exposure Mitigation; and

• Co-operation on Environmentally Sustainable Use of Nanotechnology