Chemical name: NCC ether

Final regulatory action has been taken for the category: Industrial

Final regulatory action: The chemical is Severely Restricted

Use or uses prohibited by the final regulatory action:

The Regulations prohibit the manufacture, use, sale, offer for sale or import of NCC ether, with the exceptions listed below.

Use or uses that remain allowed:

The Regulations do not apply to the incidental presence of NCC ether or for use in a laboratory for scientific research purposes or as a laboratory analytical standard.

The final regulatory action was based on a risk or hazard evaluation: Yes

Summary of the final regulatory action:

The Prohibition of Certain Toxic Substances Regulations, 2005 prohibit the manufacture, use, sale, offer for sale and import of toxic substances listed in Schedules 1 and 2 to the Regulations. NCC ether is found in Schedule 1, which lists prohibited toxic substances subject to total prohibition, with the exception of incidental presence.

The reasons for the final regulatory action were relevant to: Human health and environment

Summary of known hazards and risks to human health:

Note: NCC ether was assessed under the original Canadian Environmental Protection Act (CEPA). While the Act was updated in 1999, the conclusions of the assessment remain the same. This notification is based on the assessment and therefore references the original Act.

Background

The Canadian Environmental Protection Act (CEPA), authorizes the Ministers of the Environment and of Health to investigate Substances New to Canada that may contaminate the environment and cause adverse effects on the environment or on human health.

Also, pursuant to section 29 of the Act, where Ministers have assessed any information, and suspect that a substance is toxic, the Minister may prohibit any person from manufacturing or importing the substance, before the period for assessing the information is expired. Under Section 11 of CEPA, a substance is considered toxic if:

… it is entering or may enter the environment in a quantity or concentration or under conditions

1. having or that may have an immediate or long-term harmful effect on the environment;
2. constituting or that may constitute a danger to the environment on which human life depends; or
3. constituting or that may constitute a danger in Canada to human life or health.

In December, 1995, NCC ether (4-Chlorophenyl)cyclopropylmethanone, O-[(4-nitrophenyl)-methyl]oxime was notified to the Minister of Environment pursuant to subsection 26(1) of CEPA and was subsequently assessed pursuant to subsection 28(1). The assessment led to a suspicion that the substance was toxic and, consequently, its manufacture and importation was prohibited on December 20, 1995.

In view of the demonstrated contact sensitization, adverse health effects in the subchronic study, clear evidence of in vitro genotoxicity in the Ames test and equivocal and/or inconclusive evidence of genotoxicity in one in vitro and in one in vivo test, NCC ether was considered capable of posing at least a moderate degree of health hazard.

There was reason to suspect NCC ether is toxic under paragraph 11(c) of CEPA. It may enter the environment in quantity or concentration or under conditions constituting or that may constitute a danger in Canada to human life or health.

Expected effect of the final regulatory action in relation to human health:

NCC ether was originally prohibited under the Prohibition Regulations. At that time NCC ether was not used, sold, produced, imported or exported in Canada. The only way to ensure that it was not introduced into the Canadian market was through a ban. The amended Regulations continue to prohibit the manufacture, use, sale, offer for sale, or import of NCC ether towards the objective of virtual elimination.

Summary of known hazards and risks to the environment:

Note: NCC ether was assessed under the original Canadian Environmental Protection Act (CEPA). While the Act was updated in 1999, the conclusions of the assessment remain the same. This notification is based on the assessment and therefore references the original Act.

Background

The Canadian Environmental Protection Act (CEPA), authorizes the Ministers of the Environment and of Health to investigate Substances New to Canada that may contaminate the environment and cause adverse effects on the environment or on human health.

Also, pursuant to section 29 of the Act, where Ministers have assessed any information, and suspect that a substance is toxic, the Minister may prohibit any person from manufacturing or importing the substance, before the period for assessing the information is expired. Under Section 11 of CEPA, a substance is considered toxic if:

… it is entering or may enter the environment in a quantity or concentration or under conditions

a)having or that may have an immediate or long-term harmful effect on the environment;

b)constituting or that may constitute a danger to the environment on which human life depends; or

c)constituting or that may constitute a danger in Canada to human life or health.

In December, 1995, NCC ether (4-Chlorophenyl)cyclopropylmethanone, O-[(4-nitrophenyl)-methyl]oxime was notified to the Minister of Environment pursuant to subsection 26(1) of CEPA and was subsequently assessed pursuant to subsection 28(1). The assessment led to a suspicion that the substance was toxic and, consequently, its manufacture and importation was prohibited on December 20, 1995.

Based on the ecotoxicological data, Daphnia magna was the most sensitive aquatic species tested. The 48 hour EC₅₀ was reported to be 18 mg/L and the no observed effect concentration was reported to be 4.7 mg/L. These data were used to establish freshwater organism concentrations of concern for chronic and acute effects of 18 and 470 ng/L, respectively. Manufacture, processing and use information submitted indicated that the substance's release into the environment would have been primarily into receiving waters via plant effluent. The predicted environmental concentration was estimated to be 800 ng/L in receiving waters under potential production conditions.

The predicted environmental concentration in the receiving water exceeded the concern concentration for chronic and acute effects by factors of 40 and 2 respectively.

NCC ether is expected to persist in the environment as degradation was not observed in ready biodegradation tests and significant hydrolysis did not occur under environmentally relevant conditions. In addition, the log of the octanol/water partition coefficient (log K_ow) for NCC ether is 6.3, indicating the substance has the potential to bioaccumulate in organisms.

NCC ether was determined to be toxic under paragraph 11(a) of CEPA. It may enter the environment in a quantity or concentration or under conditions that may have an immediate or long-term effect on the environment.

Expected effect of the final regulatory action in relation to the environment:

NCC ether was originally prohibited under the Prohibition Regulations. At that time NCC ether was not used, sold, produced, imported or exported in Canada. The only way to ensure that it was not introduced into the Canadian market was through a ban. The amended Regulations continue to prohibit the manufacture, use, sale, offer for sale, or import of NCC ether towards the objective of virtual elimination.

Date of entry into force of the final regulatory action: 15/05/2005