Summary of risk assessment: significant new activity notification for oxirane
Significant New Activity Notification: Oxirane, (chloromethyl)- (Epichlorohydrin), Chemical Abstracts Service Registry Number 106-89-8
Health Canada & Environment and Climate Change Canada
Oxirane, (chloromethyl)-, Chemical Abstracts Service Registry Number (CAS RN) 106-89-8 (epichlorohydrin), was identified during the categorization of the Domestic Substances List as a high priority for assessment. It underwent a screening assessment in Batch 2 of the Challenge (Canada 2008), which was followed by a proposed Risk Management Approach document on January 31, 2009 (Canada 2009). In the screening assessment, it was concluded that epichlorohydrin met the criteria of section 64(c) of the Canadian Environmental Protection Act, 1999 (CEPA), meaning that it is a substance which is entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health (Canada 1999). It was added to Schedule 1 of CEPA on February 16, 2011 (Canada 2011).
The risk management objective identified in the proposed Risk Management Approach document was to prevent increases in exposure to the substance. The risk management actions proposed for epichlorohydrin included:
- a provision to notify the federal government, for the purpose of assessment, of any proposed new uses of epichlorohydrin, through the Significant New Activity provisions under CEPA (Canada 2012);
- scrutiny of all future submissions for the use of epichlorohydrin in epoxy linings to ensure that residual levels in the finished food packaging material are as low as possible;
- the removal of epichlorohydrin from the Food Additives Table, Division 16 (Food Additives) of the Food and Drug Regulations; and
- the addition of epichlorohydrin and the two hair dyes that use epichlorohydrin in their manufacture (HC Blue No. 5 [CAS RN 68478-64-8; CAS RN 158571-58-5] and HC Blue No. 4 [CAS RN 158571-57-4]) to the Cosmetic Ingredient Hotlist as prohibited for use in cosmetic products (June 2010).
The substance is a chemical that can be classified as a halogenated alkyl epoxide.
Significant New Activity Notification
In October 2014, the Government of Canada received a Significant New Activity Notification (SNAN) for a new activity involving epichlorohydrin. The notifier proposed to import the substance for distribution in 200 L drums. The epichlorohydrin is then processed in a closed system to manufacture an intermediate chemical substance, which is then used to manufacture a drug for cardiac arrhythmia treatment. Epichlorohydrin is present as a residual in the chemical intermediate, and the concentration in the final product (pharmaceutical) is negligible.
Environmental Fate and Behaviour
The environmental fate and behaviour of the substance was described in the original screening assessment report (Canada 2008). The substance is volatile (vapour pressure of 1600-2280 Pa) and water soluble (60-65.9 g/L). The log Kow was reported to be 0.3-0.45. The substance is not expected to be adsorptive and is considered to be mobile in the environment. It was reported to be persistent in air, but not in water, soil or sediments. Epichlorohydrin meets the criteria for persistence but does not meet the criteria for bioaccumulation, as defined by the Persistence and Bioaccumulation Regulations (Canada 2000).
Based on experimental ecological data, the substance has moderate acute toxicity in different fish species and daphnia (LC50 10-100 mg/L). However, given the low use volumes and negligible exposure pathways resulting from the notified activity, low exposure is expected.
Given the ecotoxicological and release profiles, the use of the substance as proposed in the notification does not pose a risk to the environment, and therefore is not likely to cause ecological harm in Canada.
Human Health Assessment
Based on the information provided in the SNAN, there is no anticipated exposure to the general population that would occur as a result of the notified use. Consequently, it has been concluded that the notified use of the substance is not likely to pose a significant risk to the general population, and is therefore not likely to be harmful to human health.
No information received in this notification puts into question the prior determination that the substance meets the criteria set out under section 64(c) of CEPA. However, when used as notified, use of the substance to manufacture a chemical intermediate is not likely to present a significant risk to human health or the environment.
Based on the information provided in the notification, and the risk assessment analysis, this activity does not result in an increase in exposure to the general public and does not pose an additional risk to human health. Additionally, the substance does not pose an ecological risk. Therefore, no additional risk management is recommended for epichlorohydrin.
As no specific concerns have been identified for this activity, the government is considering amending the existing SNAc requirements in relation to epichlorohydrin to target only the use(s) of the substance that may result in potential exposure(s) of concern. However, the current SNAc order remains in force until an amended order is registered and published in the Canada Gazette, Part II.
Canada. 1999. Canadian Environmental Protection Act, 1999. S.C. 1999, c.33. Canada Gazette Part III, vol. 22, no. 3.
Canada. 2000. Canadian Environmental Protection Act, 1999: Persistence and Bioaccumulation Regulations. P.C. 2000-348, 29 March, 2000, SOR/2000-107.
Canada. 2011. Order adding a toxic substance to schedule 1 to the Canadian Environmental Protection Act, 1999. SOR/2011-25. Canada Gazette, Part II, vol. 145, no. 4, February 16, 2011.
Canada. 2012. Order 2012-87-07-01 Amending the Domestic Substances List, Canadian Environmental Protection Act, 1999. SOR/2012-144. Canada Gazette, Part II, vol. 146, no. 15, July 18, 2012.
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