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Screening Assessment for the Challenge Siloxanes and Silicones This page has been archived on the Web Information identified as archived is provided for reference, research or recordkeeping purposes.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. MHDnMH was originally classified as an organic UVCB (Unknown or Variable Composition, Complex Reaction Products or Biological Material) during the DSL Categorization. Based on new information received, the substance is considered to be an organic siloxane polymer. MHDnMH is not naturally produced in the environment. In 2006, between 10 000 and 100 000 kg of the substance were manufactured in Canada, and less than 100 kg were imported into the country. Based on reported use, MHDnMH is manufactured as an intermediate polymer, and then exported in bulk form out of the country for producing plastics. During the industrial process, a small amount of the polymer is released to wastewater, and to a lesser extent air and land; however, the total environmental release is not significant. Information for an analogous polymer, polydimethylsiloxanes (PDMS), has been used for assessing MHDnMH. Based on the read across data of the analogue, the substance is expected to be persistent in the environment. Based on the information for the analogue on the potential for bioaccumulation, and taking into account its relatively large molecular size, the substance is not likely to be bioavailable and is expected to have a low potential to accumulate in the lipid tissues of organisms. The substance therefore meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, new modelled toxicity data for the substance and experimental data for an analogous polymer indicate that MHDnMH has a low potential to cause harm to organisms in water, soil, and sediment. For this screening assessment, a conservative exposure scenario was developed in which an industrial operation discharges MHDnMH into the aquatic environment. The predicted environmental concentration in water was well below the predicted no effect concentration calculated for the aquatic organisms. Therefore, based on the information presented in this screening assessment, it is expected that MHDnMH is not 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 or that constitute or may constitute a danger to the environment on which life depends. Empirical health effects data were not identified for MHDnMH. Based louis vuitton shoes pumps on health effects data for PDMS, and on the weight of evidence based risk assessments for PDMS conducted by international agencies, it is considered that MHDnMH demonstrates low hazard potential. Based on the estimated concentrations of MHDnMH in environmental media (air, drinking water and soil), exposure of the general population is expected to be negligible. General population exposure can occur through use of consumer products containing MHDnMH. Margins between conservative upper bounding estimates of exposure for MHDnMH and effect levels from health effects studies with the analogue (PDMS) are considered adequate to address uncertainties in the health effects and exposure databases. It is therefore concluded that MHDnMH 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. Based on the information available, it is concluded that the Reduced Regulatory Requirement form of MHDnMH does not meet any of the criteria set out in section 64 of CEPA 1999. Given the complexity associated with the polymer formulation and the potentially hazardous properties associated with low molecular weight polymers, there is concern that new activities for MHDnMH which have not been identified or assessed under CEPA 1999 could lead to the substances meeting the criteria as set out in section 64 of the Act. Therefore, it is recommended that the DSL be amended to indicate that MHDnMH meets the criteria. Should other forms of MHDnMH, not meeting the Reduced Regulatory Requirement polymer criteria, be introduced on the Canadian market, those forms would be subject to the requirements of the New Substances Notification Regulations. 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 to human health. Based on the information obtained through the categorization process, the Ministers identified a number of substances as high priorities for action. The substance, siloxanes and silicones, di Me, hydrogen terminated (MHDnMH), was initially identified as a high priority for assessment of ecological risk during the DSL Categorization as it was found to be persistent, bioaccumulative and inherently toxic to aquatic organisms and is believed to be in commerce in Canada. The Challenge for this substance was published in the Canada Gazette on September 26, 2009 (Canada 2009). 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, submissions of information pertaining to the properties and uses of the substance were received. Although MHDnMH was determined to be a high priority for assessment with respect to the environment, it did not meet the criteria for GPE or IPE and high hazard to human health based on classifications by other national or international agencies for carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity. Screening assessments focus on information fake louis vuitton wallet amazon critical to determining whether a substance meets the criteria set out louis vuitton amazon japan in section 64 of CEPA 1999. Screening assessments examine scientific information and develop louis vuitton purses alma conclusions by incorporating a weight of evidence approach and precaution.
This screening assessment includes consideration of information on chemical properties, hazards, uses and exposure, including the additional information submitted under the Challenge. Data relevant to the screening assessment of this substance were identified in original literature, review and assessment documents, stakeholder research reports and from recent literature searches, up to May 2010 for the human health sections and December 2010 for ecological sections of the document. Key studies were critically evaluated; modelling results may have been used to reach conclusions.
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