Environmental Risk Assessment Report: Decamethylcyclopentasiloxane
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Environmental Risk Assessment Report: Decamethylcyclopentasiloxane Science Report Environmental Risk Assessment: Decamethylcyclopentasiloxane 1 The Environment Agency is the leading public body protecting and improving the environment in England and Wales. It’s our job to make sure that air, land and water are looked after by everyone in today’s society, so that tomorrow’s generations inherit a cleaner, healthier world. Our work includes tackling flooding and pollution incidents, reducing industry’s impacts on the environment, cleaning up rivers, coastal waters and contaminated land, and improving wildlife habitats. Published by: Author(s): Environment Agency, Rio House, Waterside Drive, Aztec West, Brooke D N, Crookes M J , Gray D and Robertson S Almondsbury, Bristol, BS32 4UD Tel: 01454 624400 Fax: 01454 624409 Dissemination Status: www.environment-agency.gov.uk Publicly available / released to all regions ISBN: 978-1-84911-029-7 Keywords: © Environment Agency April 2009 Decamethylcyclosiloxane, siloxane All rights reserved. This document may be reproduced with prior Research Contractor: permission of the Environment Agency. Building Research Establishment Ltd, Bucknalls Lane, Garston, Watford, WD25 9XX. Tel. 01923 664000 The views expressed in this document are not necessarily those of the Environment Agency. Environment Agency’s Project Manager: Steve Robertson, Chemicals Assessment Unit, Red Kite House, This report is printed on Cyclus Print, a 100 per cent recycled Howbery Park, Wallingford OX10 8BD. Tel 01491 828555 stock, which is 100 per cent post consumer waste and is totally chlorine free. Water used is treated and in most cases returned Collaborator(s): to source in better condition than removed. D Gray, Health and Safety Executive Further copies of this report are available from: Product code: The Environment Agency’s National Customer Contact Centre SCHO0309BPQX-E-P by emailing [email protected] or by telephoning 08708 506506. Science Report Environmental Risk Assessment: Decamethylcyclopentasiloxane 2 Science at the Environment Agency Science underpins the work of the Environment Agency, by providing an up to date understanding of the world about us, and helping us to develop monitoring tools and techniques to manage our environment as efficiently as possible. The work of the Science Department is a key ingredient in the partnership between research, policy and operations that enables the Agency to protect and restore our environment. The Environment Agency’s Science Group focuses on five main areas of activity: • Setting the agenda: To identify the strategic science needs of the Agency to inform its advisory and regulatory roles. • Sponsoring science: To fund people and projects in response to the needs identified by the agenda setting. • Managing science: To ensure that each project we fund is fit for purpose and that it is executed according to international scientific standards. • Carrying out science: To undertake the research itself, by those best placed to do it - either by in-house Agency scientists, or by contracting it out to universities, research institutes or consultancies. • Providing advice: To ensure that the knowledge, tools and techniques generated by the science programme are taken up by relevant decision- makers, policy makers and operational staff. Steve Killeen Head of Science Science Report Environmental Risk Assessment: Decamethylcyclopentasiloxane 3 Executive Summary The Environment Agency’s environmental risk assessment for decamethylcyclopentasiloxane (D5) is based on the methods outlined in the European Union (EU) Technical Guidance Document for the risk assessment of new and existing chemicals. The persistence, bioaccumulative, and toxic (PBT) status is assessed, and a ‘quantitative’ risk assessment made by comparison of exposure with effects. Persistence, bioaccumulative, and toxic status D5 meets the screening criteria for a very persistent (vP) and very bioaccumulative (vB) substance. It is unlikely to meet the screening criteria for persistent organic pollutants in long-range transport. Laboratory studies indicate that D5 is not readily biodegradable in aquatic systems. However, it is difficult to interpret some of the results because of the rapid loss of D5 through volatilisation. A standard test modified to prevent such loss gives a hydrolysis pH- dependent half-life of 71 days at pH 7 and nine days at pH 8 (both at 25°C). The equivalent half-life at pH 7 and12°C is estimated to be around 315 days, and those at higher pHs (e.g. around 8, as can occur in the marine environment) and 9°C are estimated as 64 days. The final products of the hydrolysis of D5 are not thought to have PBT properties. The lack of biodegradation in laboratory tests and the relatively slow rate of hydrolysis at pHs around 7 mean D5 meets the persistent and vP criteria for water. Although, the volatility of D5 affects its residence time in water–sediment systems, and is probably the predominant removal mechanism for D5 from water, adsorption onto sediments also occurs. D5 lost to air because of its high volatility undergoes subsequent degradation in the air. The bioconcentration factor (BCF) for BCF of D5 in fish is 7060 l/kg (determined experimentally). In addition, D5 is accumulated by fish from diet, and a growth-corrected and lipid-normalised biomagnification factor (BMF) of 3.9 is derived from the available experimental data. Thus, D5 meets the vB criterion. D5 shows essentially no acute toxicity to aquatic organisms when tested at concentrations up to its water solubility limit, as do the limited long-term toxicity data available. In addition, D5 is not classified as a carcinogenic, mutagenic, or reprotoxic compound. Based on these data D5 does not meet the toxic criterion. However, the available long-term fish toxicity data may not cover all of the relevant toxicological endpoints, so it is not fully established whether or not D5 has the potential to cause effects in fish over long-term exposure. For example, a recent accumulation study with fish shows only slow depuration of accumulated D5 from the liver, and the long-term impact of the accumulation in liver of fish is not known. In addition, effects on liver weight occur in rats at relatively low doses of D5. However, it is not clear if these effects alone are sufficient to warrant D5 as toxic. The overall conclusions of the PBT assessment are: • D5 meets the screening criteria for vPvB substances but some mitigating factors need to be considered further, in particular that D5 is lost from water by volatilisation to the air, where subsequent degradation occurs. Science Report Environmental Risk Assessment: Decamethylcyclopentasiloxane 4 • The current criteria for persistence are related to degradation half-lives in each individual compartment (aquatic, sediment, etc.). These may not be the most appropriate for a substance such as D5 as it is likely to be removed from the aquatic compartment more rapidly by physical process than by degradation. Thus, the overall persistence of the substance, including the potential for transport over distances and the effects at remote locations, needs to be assessed. Currently there are no criteria for this, so both further scientific discussion and consideration at a policy level are required. • Uncertainties exist over the long-term toxicity of D5 to fish. Available data suggest that it shows no adverse effects at concentrations up to its water solubility, but these data may not cover all the relevant toxicological endpoints. Further long-term toxicity testing with fish will reduce these uncertainties, but the actual need for such tests is unclear. Quantitative risk assessment The risks from the normal use of D5 to water, sediments, soil, and predators are assessed using standard models and the information available. The property data set is reasonably complete, but in some areas further information will be valuable. This assessment therefore makes recommendations about the significance of gaps and or uncertainties in the data, and suggests where further research should be focussed. The main uses of D5 are as an intermediate for the production of other chemicals (silicone polymers), in personal care products (e.g. cosmetic products and skin- and hair-care products), in household products, and in industrial/institutional cleaning. Use as an intermediate in the formation of silicone polymers effectively consumes the D5, although trace amounts in the final products can be subsequently released to the environment. Use of D5 in personal care and household products results in widespread exposure to the environment. Estimates of the potential emissions to the environment from D5’s key life-cycle stages are based on industry research and Emission Scenario Documents, or, in the absence of any other information, worst-case default assumptions. Monitoring data available for some life- cycle stages are taken into account where relevant. Risk characterisation ratios above one indicate an unacceptable risk for the environment and are identified for some life-cycle stages relevant to the UK. Some information provided by industry is treated as confidential and not given in this report, although the data are used to develop appropriate emission scenarios. These data are included in a confidential annex that supports the assessment, which is available via the Project Manager where appropriate. The overall conclusions of the quantitative risk assessment are: • No risks are identified to the air, water, and