Macrocyclic Lactones and Ketones, Ionones and Cyclohexanone Group – information sheet
On this page
- About these substances
- Exposure of Canadians and the environment
- Key health and ecological effects (hazard)
- Risk assessment outcomes
- Important to know
- The Government of Canada conducted a science-based evaluation of 11 substances in the Macrocyclic Lactones and Ketones, Ionones and Cyclohexanone Group [previously identified as the Musks (macro/poly cyclic) Group]. This screening assessment addresses the potential for harm to Canadians and to the environment.
- Under the Canadian Environmental Protection Act, 1999 (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 upon the level of exposure.
- The ecological hazard and exposure potentials of these 11 substances were classified using the Ecological Risk Classification of Organic Substances Approach.
- Certain substances in the Macrocyclic Lactones and Ketones, Ionones and Cyclohexanone Group may have potential to cause human health and/or ecological effects; however, the risk to Canadians is low at current levels of exposure. Therefore, it is proposed that these 11 substances are not harmful to human health or to the environment.
About these substances
- This screening assessment focuses on 11 of 13 substances referred to collectively as the Macrocyclic Lactones and Ketones, Ionones and Cyclohexanone Group. The substances addressed are exaltolide, hexadecanolide, exaltone, muskone/muscone, civetone, hexadecenlactone/ambrettolide, isoambrettolide, musk amberol/ambrettone, irone, 1-methyl-α-ionone and cyclohexanone. They were assessed as part of the third phase of the Chemicals Management Plan (CMP).
- The other 2 substances in the Macrocyclic Lactones and Ketones, Ionones and Cyclohexanone Group (CAS RNs 8001-04-5 and 68140-48-7) were determined to be of low concern to both human health and the environment, through other approaches. Conclusions for these substances are provided in the Screening Assessment for Substances Identified as Being of Low Concern using the Ecological Risk Classification of Organic Substances and the Threshold of Toxicological Concern (TTC)-based Approach for Certain Substances .
- The Government gathers information on substances, including details on their commercial status in Canada, to support risk assessment and risk management of substances under the CMP.
- Four of the 11 substances (exaltolide, muskone/muscone, civetone and cyclohexanone) occur naturally in the environment.
- Substances in the Macrocyclic Lactones and Ketones, Ionones and Cyclohexanone Group are used mainly as fragrances or fragrance ingredients.
- In Canada, these substances are also used in products available to consumers, including cosmetics (such as body lotion and eau de toilette), sunscreen, and do-it-yourself (DIY) products (such as wall paint).
Exposure of Canadians and the environment
- Exposure of Canadians to these substances from the environment (for example, water) or food is considered minimal.
- Canadians may be exposed to low levels of some of these substances from the use of certain cosmetics and DIY products.
- For the ecological assessment, all 11 substances in the Macrocyclic Lactones and Ketones, Ionones and Cyclohexanone Group were identified as having low ecological exposure.
Key health and ecological effects (hazard)
- On the basis of available information, no effects of concern for human health were identified for 8 of the 11 substances in this group.
- For irone and 1-methyl-α-ionone, a comparative approach based on properties of similar chemicals, called read-across, was used for assessing potential health effects. Using this data, adverse effects on the kidneys observed in laboratory studies were considered to be the important or "critical" effects and were used for characterizing the risk to human health from exposure to these 2 substances.
- For cyclohexanone, several international reports were reviewed, including one by the Organisation for Economic Co-operation and Development (OECD) Cooperative Chemicals Assessment Programme. On the basis of this assessment, cyclohexanone showed low potential for adverse effects through the oral and inhalation routes of exposure.
- For the ecological assessment, 9 of the 11 substances were identified as having a low ecological hazard potential while the other 2 substances (irone and 1-methyl-α-ionone) were identified as having a moderate ecological hazard potential. This was based on their moderate potential to cause adverse effects in the aquatic food webs due to their potential to accumulate in organisms.
Risk assessment outcomes
- Based on a comparison of levels to which Canadians can be exposed to these 11 substances and levels associated with health effects, the risk to human health from these substances is considered to be low.
- The Ecological Risk Classification of Organic Substances Approach characterized these 11 substances as posing a low risk of harm to the environment.
- The Government of Canada published the Draft Screening Assessment for Macrocyclic Lactones and Ketones, Ionones and Cyclohexanone Group on May 19, 2018. This publication has a 60-day public comment period ending on July 18, 2018.
Proposed screening assessment conclusions
- As a result of this assessment, the Government is proposing that these 11 substances are not harmful to human health at current levels of exposure.
- The Government is also proposing that these 11 substances are not entering the environment at levels that are harmful to the environment.
Important to know
- Substances in this group can be found in certain products available to consumers. Canadians can follow any safety warnings and directions on product labels and dispose of products responsibly.
- Canadians who may be exposed to any of these substances in the workplace can 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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