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Screening Assessment for the Challenge Octamethylcyclotetrasiloxane D4 This page has been archived on the Web Information identified as archived is provided for reference, research or recordkeeping purposes.
It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. During the categorization process, this substance was identified as a high priority for screening assessment and included in the Ministerial Challenge because it had been considered to pose an intermediate potential for exposure to individuals in Canada and has been classified by another agency on the basis of reproductive toxicity. Further, it had initially been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity (PBiT) to non human organisms and it is known to be in commerce in Canada. Octamethylcyclotetrasiloxane, or D4, is an industrial chemical which was not manufactured by any company louis vuitton bags new in Canada in 2006 in a quantity above the reporting threshold of 100 kg, but which was imported into the country in 2006 at a louis vuitton alma damier ebene pm total quantity between 1 and 10 kg as an essentially pure substance, in mixtures with other cyclic siloxanes, as a residual in silicone polymers, and in finished consumer products. The principal sources of release of D4 to the environment are industrial processes in which it is reacted to form silicone polymers, from blending, formulation and packaging operations. It is also released from the use and disposal of personal care products. Air, wastewater and agricultural soil are the principal receiving environmental media for D4 based on its physical chemical properties and its use patterns. air, D4 is persistent with calculated atmospheric half lives of more than 5 days. D4 has the potential to be transported over long distances in the atmosphere. However, it has a low potential to be deposited in water or soil in remote regions. The hydrolysis half lives for D4 under Canadian water conditions (pH 6 9, temperature 5 25 C) are estimated to range from hours to 45 days, indicating the substance is not persistent in water. The final hydrolysis product dimethylsilanediol is expected to biodegrade quite slowly. D4 degradation in sediment appears to be much slower with half lives of 49 to 588 days estimated under realistic Canadian sediment conditions (temperature of 5 25 C), indicating the substance may be persistent in sediment. D4 is not considered persistent in soil, based on evidence of clay catalysed degradation, with dimethylsilanediol being louis vuitton replica handbags amazon the stable hydrolysis product. Therefore, D4 has been determined to meet the persistence criterion as set out in the Persistence and Bioaccumulation Regulations. The empirical bioconcentration factor and modelled bioaccumulation factor are both above 5000, indicating D4 may have a high potential to accumulate in aquatic organisms. However, data from a biomagnification study in fish and a biota sediment accumulation study in invertebrates suggest that the bioaccumulation potential of D4 may be lower, possibly due to reduced bioavailability. Therefore, while D4 has the potential to accumulate in biota, it is not possible to conclude at this time that D4 meets the criterion for bioaccumulation as set out in thePersistence and Bioaccumulation Regulations based on consideration of the conflicting evidence from laboratory studies and predictive models. Adverse effects from exposure to D4 in sediment dwelling organisms were observed at concentrations above 44 mg/kg. The experimental toxicity data show that the substance can also cause long term toxicity to sensitive pelagic aquatic organisms at relatively low concentrations (below its water solubility limit of 0.056 mg/L ). Risk quotients derived from exposure scenarios involving discharges of D4 from both consumer use and industrial operations, show a total of 249 sites (23.4%) evaluated across Canada have predicted environmental concentrations in water higher than predicted no effect concentrations for aquatic organisms. Considering D4's potential to bioaccumulate in biota and its high toxicity to sensitive aquatic organisms, long term environmental exposure to D4 may cause adverse effects to aquatic organisms in certain Canadian environments. Based on this evidence, it is concluded that D4 has the potential to cause ecological harm. Based principally on the weight of evidence based assessments of the European Commission and the Danish EPA, an important effect of D4 exposure is impaired fertility. However, the Danish EPA also identified the liver as a target organ for D4 exposures. The critical effect level for repeated dose toxicity via inhalation was based not only on increased liver weights, but also on effects observed in other organs (adrenals, thymus, lungs) in a three month rat inhalation study. Comparison of the critical effect level for repeated dose effects via inhalation and the conservative upper bounding exposure estimate via inhalation for D4 results in an adequate margin of exposure. The critical effect level for repeated dose toxicity via the oral route was based on decreased serum estradiol in 7 day mouse studies and decreased body weights and relative liver weights in fetuses in 8 day rat studies (D4 administered to pregnant females). Comparison of the critical effect level for repeated dose effects via the oral route and the upper bounding estimate of daily intake of D4 by the general population in Canada, results in an adequate margin of exposure. Based on an independent review of a refined exposure assessment for personal care products, an adequate margin of exposure was derived by comparison of the critical effect level for repeated dose effects via the oral route and a conservative upper bounding estimate of daily intake of D4 via use of personal care products. Based on the available information on its potential to cause ecological harm, it is concluded that D4 is entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long term harmful effect on the environment or its biological diversity. Based on the available information on its potential to cause harm to human health, it is concluded that D4 is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health. This substance will be included in the upcoming Domestic Substances List inventory update initiative. In addition and relevant, research and monitoring will support verification of assumptions used during the screening assessment and, appropriate, the performance of potential control measures identified during the risk management phase. Based on the information available, it is concluded that D4 meets one or more of the criteria set out in section 64 of is there a louis vuitton store in atlanta the Canadian Environmental Protection Act, 1999. Top of Page IntroductionThe Canadian Environmental Protection Act, 1999 (CEPA 1999) (Canada 1999) requires the Minister of the Environment and the Minister of Health to conduct screening assessments of substances that have met the categorization criteria set out in the Act to determine whether these substances present or may present a risk to the environment or human health. Based on the results of a screening assessment, the Ministers can propose to take no further action with respect to the substance, to add the substance to the Priority Substances List (PSL) for further assessment, or to recommend that the substance be added to the List of Toxic Substances in Schedule 1 of the Act and, applicable, the implementation of virtual elimination. Based on the information obtained through the categorization process, the Ministers identified a number of substances as high priorities for action. The substance Cyclotetrasiloxane, octamethyl, also known as D4, was identified as a high priority for assessment of human health risk because it was considered to present an IPE and had been classified by other agencies on the basis of reproductive toxicity. It was also identified as a high priority for assessment of ecological risk as it was found to be persistent (P), bioaccumulative (B) and inherently toxic (iT) to aquatic organisms and is known to be in commerce in Canada. The Challenge for this substance was published in the Canada Gazette on May 12, 2007 (Canada 2007). A substance profile was released at the same time. The substance profile presented the technical information available prior to December 2005 that formed the basis for categorization of this substance. As a result of the Challenge, more than 100 submissions of information were received for this substance pertaining to its physical and chemical properties, bioaccumulation potential, persistence, ecotoxicology, quantity in commerce, and so on.
Under CEPA 1999, screening assessments focus on information critical to determining whether a substance meets the criteria for defining a chemical as toxic as set out in section 64 of the Act, "64. [.] a substance is toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that (a) have or may have an immediate or long term harmful effect on the environment or its biological diversity.
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