Part B contains concise guidance on hazard assessment. The three updates concern three other appendices in the same guidance document (to Chapters R.7a, R.7b, and R.7c). These characteristics will facilitate transport of vinyl toluene via passive diffusion. This includes an overview on the intended outcomes and main contents of the chemicals safety assessment (CSA). Welcome to the ECHA website. Updated CSR format can be found in the Illustrative chemical safety report and Templates for CSRs: Please, note that Part G of the IR&CSA guidance has been made obsolete and hence removed from the ECHA website. applicability of the general principles given in Chapter R.7c (i.e. The Waste Framework Directive aims to protect the environment and human health from the generation and management of waste and to improve efficient use of resources. What is the Classification and Labelling Inventory? 622-97-9). the generation of the additional information required to fill the data gaps. ECHA (May 24, 2017). It also includes the overall approach to making cost-effective decisions during the iterative process of conducting the CSA, and a pathfinder to the different elements of this guidance. The information has been updated and transferred to two more appropriate Guidance documents which have been recently revised. For chemical safety assessment purposes, based on the physicochemical properties and information in the dossier, an oral absorption rate of 50% is accepted. The molecular weight (118 g/mol) and log Pow (3.38) of vinyl toluene are somewhat favourable for wide distribution. REACH, CLP and biocides for non-EU companies, Submitting downstream user notification of authorised uses, Submitting a downstream user report for unsupported uses, Submitting a downstream user report for classification differences, How to submit and update your C&L notification, Requesting an alternative chemical name in mixtures, Technical equivalence and chemical similarity, Small and Medium-sized Enterprises (SMEs), How to determine the company size category, What to do if you incorrectly indicated the SME size category. Vinyl toluene may be distributed, metabolised and is likely to be excreted in the urine. The molecular weight of vinyl toluene is 118 g/mol and the log Pow is 3.38, so a dermal absorption rate of 100% would be applicable. Close Find out more on how we use cookies. Figure 2: Overall process related to information requirements and chemicals safety assessment under REACH. Guidance on information requirements and chemical safety assessment . The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). ECHA organises consultations to get feedback from all interested parties and to gather the widest possible range of scientific information for the regulatory processes. Read more. ECHA states that these three documents provide nano-specific advice to help registrants meet the information requirements set out in REACH Annexes VI-XI. Comments: The Committee confirmed the ADI of 0–0.0005 mg/kg body weight established by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) in 2011, based on an overall no-observed-adverse-effect level (NOAEL) of 0.25 mg/kg body weight per day for neurotoxicity from 14- and … The Support section provides tools and practical guidance to companies which have responsibilities under the EU chemicals legislation. : - Section 2.1.1 Aquatic bioaccumulation - Section 2.1.2 Effects on terrestrial organisms This information has not been reviewed or verified by the Agency or any other authority. Section D.2 describes the understanding that a registrant should have on the properties and the life cycle of his substances in order to determine his assessment approach and the corresponding scope of exposure assessment. section R… Determination of Predicted No-effect-Effect levels (PNEC) in Chapter R.10 and the corresponding chapters of integrated testing strategies for the environment endpoints (Sections R.7.8 to R.7.11 in Chapter R.7b and R.7c).These sections in Chapter R.7 also include information on how to derive appropriate information for classification and labelling of the substance. An in vivo sub-chronic study in rats covering the inhalation route is available. Further details on endpoints are available in the IUCLID 5 registration dossier. It also includes considerations on combined exposure and on handling uncertainty. Get organised with your co-registrants, Dos and Don'ts for data sharing negotiations, Information requirements: 1 to 10 tonnes per year, Information requirements: 10 to 100 tonnes per year, Adaptations to the standard information requirements, Information requirements: 100 to 1000 tonnes per year, Information requirements: 1000 tonnes or above per year, How to avoid unnecessary testing on animals, How to create your registration dossier with IUCLID, How to create your registration dossier in REACH-IT, How to create your registration dossier with IUCLID cloud, 7. In a subchronic inhalation toxicity study, vinyl toluene was administered to 10 male and female F344/N rats by dynamic whole body inhalational exposure at concentrations of 0, 25, 60, 160, 400, or 1,000 ppm for 6 hours per day, 5 days/week for a total of 13 weeks. Physico-chemical properties in Section R.7.1, Overall framework for meeting the information requirements on intrinsic properties of substances (Chapter R.2), guidance on collection of available information (Chapter R.3), evaluation of information (Chapter R.4), guidance on exposure-driven waiving and exposure-triggered testing as well as other adaptations of information requirements (Chapter R.5), in depth guidance on non-testing approaches (, Brief general description of identified uses and how to give exposure scenarios a short title (, Risk management measures and operational conditions for building of exposure scenarios, including guidance on how to determine the effectiveness of risk management measures and how to make use of the risk management library initially set up during the development of the current guidance (, Exposure assessment related to consumers including releases from articles (, Exposure assessment related to the environment including releases from waste life stage (. Csa under REACH to understand the process steps and the guidance elements all these initiatives above 35.7 para-toluene. Ensure you get the best experience on our websites absorption ( < 500 g/mol and... A risk assessment and females was 60 ppm domain evaluations are available in the range for favourable oral absorption