Methylenediphenyl Diisocyanate and Diamine (MDI/MDA) substances - information sheet

Updates

The Final Screening Assessment for the MDI/MDA Substance Grouping was published on June 10, 2017 under the Substance Groupings Initiative of the Chemicals Management Plan (CMP). The assessment is summarized in this information sheet (formerly public summary) and has not changed. The section in this information sheet entitled "Preventive actions and reducing risk" communicates updates in risk management activities, namely:

May 15, 2019: Publication of a final order adding 5 MDI substances to Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA 1999).
April 6, 2019: Publication of a proposed Code of Practice for a 60-day public comment period ending on June 5, 2019.

Overview

The Government of Canada conducted a science-based evaluation, called a screening assessment, to address the potential for harm to Canadians and to the environment from 5 MDI and 2 MDA substances.
Under CEPA 1999, the risk posed by a substance is determined by considering both its hazardous properties (its potential to cause adverse human health or ecological effects) and the amount of exposure there is to people or the environment. A substance may have hazardous properties; however, the risk to human health or to the environment may be low depending on the level of exposure.
- More information on assessing risk can be found in the Overview of Risk Assessment and related fact sheets, particularly on Types of Risk Assessment Documents and the Risk Assessment Toolbox.
As a result of this screening assessment, the Government concluded that the 5 MDI substances are harmful to human health, but not to the environment. The 2 MDA substances were concluded to not be harmful to human health or the environment at levels of exposure current at the time of the assessment.

About these substances

The screening assessment focused on 5 methylenediphenyl diisocyanate substances (MDIs) and 2 methylenediphenyl diamine substances (MDAs), making up the MDI/MDA Substance Grouping.
These 7 MDIs and MDAs were assessed together due to their similarities in chemical structure, properties, and use patterns.
The substances in this grouping are man-made chemicals that are not expected to occur naturally in the environment.
The major use of 4,4'-MDI, pMDI, and of mixed MDI is in the manufacture of polyurethanes and polyurethane products, such as adhesives, coatings, insulation foams, flexible packaging laminate, and foam slabs used in furniture. They are used as adhesives in the production of engineered wood products, such as oriented strand board (wood panel used in construction).
MDIs are also used in do-it-yourself (DIY) adhesive, sealant and insulating products, such as spray polyurethane foam (SPF) products.
Globally, MDAs are used mostly in the production of MDIs.

Human and ecological exposures

The assessment indicated that exposure of Canadians to MDIs is expected to result primarily during the use of products containing unreacted or "free" MDIs, such as adhesives and sealants, including spray polyurethane foam products.
Exposure of Canadians to MDAs from the environment is expected to be low as they are not manufactured in Canada and their use is limited to a few industrial applications. Moreover, exposure to MDAs from the use of products available to consumers is not expected.
In Canada, MDIs have the potential to be released to the environment, primarily to air, during industrial uses such as in the production of engineered wood and polyurethane products.
Release of MDIs to air may also result in deposition to soil and/or surface waters in the area surrounding the release site.
MDAs are not expected to be released to the environment; however, small quantities of MDAs may form through the breakdown of MDIs when reacting with water in the environment.

Key health and ecological effects (hazard)

On the basis of available information and international classifications, the important or "critical" effects used for characterizing the risk to human health from exposure to MDIs were carcinogenicity (potential ability to cause cancer), respiratory effects including respiratory sensitization as well as dermal sensitization. Sensitization can result in breathing problems or effects on the skin.
The critical effect used to characterize risk to human health for 4,4′-MDA and pMDA was carcinogenicity (potential ability to cause cancer).
For the ecological assessment, aquatic studies suggest that both 4,4′-MDI and pMDI have low toxicity to aquatic species. MDIs also have low toxicity to the tested soil invertebrate species and plants.
Studies suggest that 4,4'-MDA is moderately to highly toxic to various aquatic organisms including algae, microorganisms, invertebrates, and fish. 4,4′-MDA shows low to moderate toxicity to soil organisms and plants and is moderately toxic to sediment-dwelling organisms and birds.

Risk assessment outcomes

As a result of the screening assessment, it was determined that the 5 MDIs may pose a risk to human health because of possible exposure from the use of certain low-pressure two-component SPF products. The risk to human health posed by 4,4'-MDA and pMDA was considered to be low.
MDIs were not expected to remain in the environment for a long time or accumulate in organisms. The amounts of MDIs that may be released to the environment were below the level expected to cause harm to organisms.
Similarly, the amounts of MDAs that may be released to the environment were also below the level expected to cause harm to organisms.
It was determined that none of these 5 MDIs or 2 MDAs meet the persistence or bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA 1999.
The Government published the Final Screening Assessment for the MDI/MDA Substance Grouping on June 10, 2017.

Screening assessment conclusions

As a result of the assessment, the Government concluded that the 5 MDIs are harmful to human health. The Government also concluded that the 2 MDAs are not harmful to human health, at levels of exposure current at the time of the assessment.
The Government concluded that none of these 5 MDIs or 2 MDAs are entering the environment at levels that are harmful to the environment.

Preventive actions and reducing risk

The Government published the Proposed Risk Management Approach for MDIs on June 10, 2017 for a 60-day public comment period. Comments received were considered and informed the proposed risk management summarized below.
The final order adding 5 MDI substances to Schedule 1 of CEPA 1999, also called the List of Toxic Substances, was published on June 8, 2017 for a 60-day public comment period.
On April 6, 2019, a Proposed Code of Practice for Certain Methylenediphenyl Diisocyanates in Low-Pressure Two-Component Spray Polyurethane Foam Products was published in the Canada Gazette, Part I for a 60-day public comment period, ending June 5, 2019.
This code of practice aims to help reduce exposure of Canadians to MDIs that may result from using low-pressure two-component spray polyurethane foam products available to Canadians. The code outlines actions for any person who manufactures, imports, or sells these products to:
- provide general information to users on safe use and handling
- communicate general information concerning health and safety procedures
- facilitate access to training materials to help promote proper use of the products
- provide retailers with general information to help promote safe use and handling of the products.
The Government developed the proposed code of practice through collaboration with stakeholders to leverage their knowledge and expertise, with the goal of developing an effective and practical risk management tool.
Although the 2 MDAs were not concluded to be harmful to human health or the environment, there may be a concern if exposures were to increase since these substances have potential effects of concern to human health and potential negative ecological effects.
Therefore, in June 2017, the Government published a notice of intent to apply Significant New Activity (SNAc) provisions of CEPA 1999 to these 2 MDAs. The publication had a 60-day public comment period.
The SNAc would require that the Government be notified of proposed new activities related to these 2 MDAs, and that the new activity be assessed for potential risks to human health and/or the environment before being undertaken.
Further information and updates on risk management actions for substances managed under the CMP can be found in the risk management actions table and the two year rolling risk management activities and consultations schedule.

Related information

MDIs are present in products available to consumers. Canadians should follow any safety warnings and directions on product labels and dispose of products responsibly.
Visit Healthy Home for more information on chemical safety in and around the home.
To minimize exposure to MDIs, Canadians can consider hiring trained professional contractors to apply low-pressure two-component SPF products instead of doing it themselves. Direction from a contractor should be taken on what to do when the product is being applied, such as leaving the area, and when to re-enter.
If using low-pressure two-component SPF products, Canadians should carefully follow the instructions for the product and contact the manufacturer for safe use and handling information. It is important to wear the correct personal protective equipment (for example, clothing and recommended respiratory protection) to avoid inhaling the substances or getting the product on the skin. Actions should also be taken to prepare the work area for safe use and application of the product (for example, proper ventilation).
Canadians who may be exposed to MDIs or MDAs in the workplace should consult with their employer and an occupational health and safety (OHS) representative about safe handling practices, applicable laws, and requirements under OHS legislation and the Workplace Hazardous Materials Information System (WHMIS).

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