Case Studies
Environmental risk evaluation report: 4-tert-pentylphenol (CAS no. 80-46-6)
M Crane, P Fisk, D Maycock, C Watts, R Wildey (contractors) H Jordinson (Environment Agency), P Ridgway (Health & Safety Executive)
4-tert-Pentylphenol (CAS number 80-46-6) belongs to a group of related substances called alkylphenols. These chemicals are of concern because they may cause effects on endocrine systems in wildlife and people. 4-tert-Pentylphenol is used as a chemical intermediate in Europe (mainly for phenolic resins), although it is supplied in relatively small amounts. Only two European suppliers are known, and further market information is commercially sensitive. This assessment is the first detailed environmental risk assessment for 4-tert-pentylphenol in the public domain. It follows the format of risk assessments set out by the Existing Substances Regulation. 4-tert-Pentylphenol is expected to biodegrade relatively quickly in the environment. It is fairly soluble in water, and its octanol-water partition coefficient (log Kow) implies a moderate bioaccumulation potential in fish. The substance is expected to partition mainly to soil and sediment when it is released to the environment. In general, no reliable environmental monitoring data are available, which means that most of the exposure assessment is based on generic industry information and a number of assumptions.
Predicted environmental concentrations are likely to be overestimates as a result. However, the releases at one UK site are based on specific information. A reasonable amount of reliable information is available to assess the environmental hazard potential of 4-tert-pentylphenol. It is acutely toxic to aquatic organisms and may cause long-term adverse effects in the aquatic environment. 4-tert-Pentylphenol is not a persistent, bioaccumulative and toxic (PBT) chemical (since it does not meet the required persistence or bioaccumulation criteria). The predicted no-effect concentration (PNEC) chosen for the freshwater risk assessment is 2 μg l-1, based on effects on fish. However, there is some uncertainty in this value, and further investigation of long-term toxicity to fish would be helpful. The PNECs for sediment and soil are derived from the surface water PNEC. The PNEC for predators exposed through food is 4.7 mg kg-1, based on mammalian toxicity data for an analogue substance.
Potential risks to the aquatic environment are identified for several parts of the life cycle. Potential risks to wastewater treatment plant and soil are also identified for one specific life cycle step. No risks are expected for air, secondary poisoning of predators or human health following environmental exposure for any stage of the life cycle. Risks for workers and consumers have not been assessed. In a UK context, there is a potential aquatic risk at a single site. This site is subject to authorisation under pollution control legislation, which offers scope for reducing emissions. The other uses that pose a potential risk are not known to occur in the UK. In any case, the calculations for these are based on default release estimates, and more detailed data on actual emissions (preferably based on measured concentrations) would be needed before risk management decisions could be taken.
The full report can be downloaded from here
Client: Confidential
The Offshore Chemicals Notification Scheme (OCNS) requires that all chemicals used in the North Sea are assessed for their likely environmental impact if released to the marine environment. For any oil field chemical used in the Norwegian sector of the North Sea, the Norwegian SKIM recommendations must be followed if the chemical only achieves a BOD28 of 20% to 60% in biodegradation tests. Such chemicals require an assessment to be made of their potential biodegradation by-products, so a tiered expert judgment approach has been developed to achieve this objective. Likely biodegradation by-products are identified based on the chemical structure of the substance and this assessment is supported by available literature on biodegradation of the substance or substances of similar structure. The biodegradation of the primary biodegradation products is also assessed using literature data, read-across and QSARs to determine whether any persistent chemicals are likely to be formed.
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Chemical Safety Assessment of Heavy Fuel Oils and production of a Chemical Safety Report
Client: CONCAWE
The new regulations for chemicals registration and assessment in the EU, REACH, entered into force earlier this year and required that industry carry out chemical safety assessments (CSA) for all substances that have not been assessed already. Although the CSA and related Chemical Safety Report are not required for some time yet, some organisations have already started their preparations for this requirement. A CSA was produced for a major petroleum product, Heavy Fuel Oil (HFO), to the requirements of the REACH regulations and according to recommendations in the Reach Implementation Project Reports. Essentially the CSR produced was a condensed Risk Assessment Report that has less detailed information on quantitative exposure than a conventional RAR.
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The benefits of chemicals regulation. Four case studies: (TBT, Methiocarb, DDT and PCBs). Project carried by Lancaster University and Centre for Ecology and Hydrology (2006).
Client: DEFRA
Defra’s Chemicals and Nanotechnologies Division let a contract to Lancaster University and the Centre for Ecology and Hydrology (CEH), to identify, quantify and where appropriate monetise the environmental and human health benefits which have arisen from chemicals regulation. The approach identified four example substances to use as case studies and to collect historical evidence to establish a link between the substance and effects reported in the environment and human health. The overall objective of the study was to illustratively monetise the benefits from introducing restrictions/bans on these chemicals, as a way to show how effective chemicals regulations can generate economic benefits.
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Expert Chemicals Advice to UK Competent Authority
Client: UK Competent Authority
Staff at wca environment have considerable experience in the environmental risk assessment of organic chemicals and trace metals and have been closely involved in Existing Substances Regulations (793/93/EEC) risk assessments for the UK Competent Authority, including provision of advice at TCNES (Technical Committee on New and Existing Chemicals). We also have experience of the Notification of New Substances and are the environmental reviewers for the UK Competent Authority of all SIARs and SIDS dossiers under the OECD's High Production Volume programme.
We have been closely involved with the development of Environmental Quality Standards for organic chemicals, plus inorganic chemicals such as metals, including assistance in preparation of the Metals Environmental Risk Assessment Guidance (MERAG) and involvement in REACH Implementation Projects. We continue to provide advice on these issues to environmental regulators. This familiarity with European chemicals management from both a regulatory and commercial viewpoint means that we are very well placed to provide REACH-related advice and services to industry.
Assessment of Regulatory Testing Strategies and Methods for Characterizing the Ecotoxicological Hazards of Nanomaterials
Client: UK Department for the Environment, Farming and Rural Affairs (Defra)
We reviewed current standard ecotoxicity methods to assess when they are fit for purpose and when they are not. Standardised aquatic and terrestrial ecotoxicology tests with microbes, algae, higher plants, invertebrates and vertebrates that are routinely used for environmental hazard assessment were assessed for their ability to measure reliably the particular hazards presented by nanomaterials. This assessment included a review of the relevant white and grey literature, and information from interviews with UK and overseas experts. Gaps identified from this assessment were used to produce recommendations for improving upon current testing strategies that take cost, feasibility and the 3Rs (Reduction, Refinement and Replacement of animals used in experimentation) fully into account.
Link to Full Report
Sensitivity and range of application of ecotoxicity test methods for assessing endocrine activity in aquatic organisms
Client: CEFIC
We compared modes of action covered by, and the sensitivity of, proposed test methods for assessing endocrine activity in aquatic organisms (fish, amphibians, and invertebrates). Currently, relevant methods identified by the OECD or USEPA are the fish 21-day screening, fish short-term reproduction, fish sexual development, fish full lifecycle; amphibian metamorphosis; copepod lifecycle; and mysid shrimp lifecycle assays. We identified model substances tested in more than one of the proposed methods for the assessment of endocrine activity in the context of population-relevant endpoints. We i) identified any regular patterns in sensitivity for particular modes of action (MoAs), ii) identified what data are required to fill gaps sufficiently to allow for the analysis to proceed for each MoA, and iii) provided advice on whether certain test types or endpoints are redundant because of low sensitivity or because a more cost-effective test or endpoint is available with similar sensitivity. The ultimate aim of this ongoing project is to develop recommendations on an appropriate testing strategy refined by MoA that balances sensitivity with the minimisation of vertebrate testing and costs.
Data gap filling using QSARs and read across
Client: Computational Toxicology Group, Joint Research Centre, European Commission
We critically reviewed the challenges in, and opportunities for, using modelling approaches (QSAR and related non-testing methods, i.e. chemical grouping and read-across) for setting PNECs. It examined existing approaches to PNEC derivation and how and where QSAR and other in silico methods might be used to improve the validity of PNECs where there is a shortage of data for all the required and appropriate endpoints. We produced case studies of substances for which there is clearly potential for use of smaller assessment factors when deriving PNECs if QSAR or read-across approaches can be used. Uncertainty in the use of non-testing estimation methods is most important when these estimates produce the lowest NOEC or EC50 (i.e., lower than any available test data). Under such circumstances use of a higher assessment factor might be appropriate. In contrast, if non-test estimated values fall within the range of test values it may be appropriate to use standard assessment factors and assume that the estimates are of similar quality to test values.
In 2003 a draft dossier was prepared in support of a proposal for endosulfan, a broad spectrum organochlorine pesticide produced by Bayer Crop Science, to be considered as a candidate for inclusion in the UN-ECE Long Range Transboundary Air Pollution (LRTAP) protocol on persistent organic pollutants. The implications of endosulfan being included on the protocol would result in the severe restriction on use of the chemical.
Clients - Bayer Crop Science
Lancaster University was asked by Bayer Crop Science to participate in a collaborative study to evaluate and interpret the environmental abiotic data on endosulfan in Arctic regions. The results from these independent studies contributed to a major part of a report which ultimately may form the basis of an EU submission to the UN-ECE in order to evaluate the risk of endosulfan to the environment. Benefits Achieved:· Continued marketing of endosulfan· Development of a risk profiling procedure for candidate persistent organic pollutants.
"As a consequence, endosulfan is continued to be used in agriculture in broad parts of the world" Leo Buerkle - Bayer Crop ScienceLink to Full Report
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