This covers information requirements on intrinsic properties of a substance under REACH, including information gathering, non-testing approaches and the so-called 'integrated testing strategies' for generating the relevant and required information on each endpoint. ECHA (May 24, 2017). Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union regulation dating from 18 December 2006. Based on the physicochemical properties and information in the dossier, vinyl toluene is expected to be absorbed after oral, dermal and inhalation exposure. These three new appendices are recommendations for registering nanomaterials. It is located in Helsinki, Finland. How to characterise and identify your substance, What you need to consider for your business, 3. Do I reach the one tonne a year threshold? It is not a subsidiary entity of the European Commission. Please upgrade your Internet Explorer to a newer version. The ECHA guidance criteria (Chapter R.7C) state that 10% dermal absorption is used when the molecular weight of the substance is >500 and the log Pow is <-1 or >4, otherwise 100% dermal absorption is used. ECHA states that these three documents provide nano-specific advice to help registrants meet the information requirements set out in REACH Annexes VI-XI. ECHA may make this information publicly available. However, in general, dermal absorption will not be higher than oral absorption, so for chemical safety assessment purposes a dermal absorption rate of 50% is accepted. All rats lived to the end of the studies. This includes: Part C contains the concise guidance on how to assess whether or not a substance is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB). The water solubility (89mg/L at 25°C) indicates low to moderate dermal uptake while the log Pow (3.38) is favourable for dermal absorption. ECHA Updates to existing Appendices to Chapters R.7a and R7.c of the Guidance on Information Requirements and Chemical Safety Assessment (IR&CSA) (Endpoint specific guidance) on ‘recommendations for nanomaterials’ regarding human health endpoints ECETOC representative: Karin Wiench, (BASF) The content of the obsoleted Part F has been revised and merged into updated Part D (section D.6 and Appendix D-1). The purpose of the reference guidance is to provide in-depth scientific and technical advice. Moreover, when no advice has been given in this appendix for a specific endpoint the advice provided in the parent Guidance should be followed. 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. ECHA. Registration, Evaluation, Authorisation and Restriction of Chemicals, Chemical Agents Directive and Carcinogens or Mutagens Directive, Guidance on Information Requirements and Chemical Safety Assessment, Substances of very high concern identification, Recommendation for the Authorisation List, Getting started with EU chemicals legislation, Classification of substances and mixtures, Harmonised classification and labelling (CLH). A selection of the most relevant ECHA Guidance documents and Reports published enables you to follow the latest advances and have a quick access to a historic library. ECHA publishes updated versions of Chapter R.11, Part C; Chapter R.7b; and Chapter R.7c of the Guidance on IR&CSA (related to PBT/vPvB Assessment) by chemwatch Posted on 03/12/2014 03/12/2014. This document was prepared by the ECHA Secretariat for the purpose of this consultation and includes only Appendix R7-2 Draft (Public) Version 2.0 – December 2016 3 NOTE Please note that the present document is a proposed amendment to specific extracts only of Appendix R7-2 to Chapter R.7c of the IR&CSA Guidance. There are no studies available via the oral route. The uncertainty analysis is further detailed in Chapter R.19. The Support section provides tools and practical guidance to companies which have responsibilities under the EU chemicals legislation. Part E contains the guidance on the risk characterisation. No compound-related lesions were observed in female rats. 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. Any producer or importer of articles shall notify the Agency, in accordance with paragraph 4 of this Article, if a substance meets the criteria in Article 57 and is identified in accordance with Article 59(1), if both the following conditions are met: The update includes the following: Update of the information on non-testing methods in sub-section R.7.7.3.1, in particular with regard to Each of the sections in Part B corresponds to the more in-depth guidance contained in Chapters R.2 to R.10. Chlorodifluoromethane or difluoromonochloromethane is a hydrochlorofluorocarbon (HCFC). This information has not been reviewed or verified by the Agency or any other authority. It covers exposure for environment, workers and consumers. Overall, the physical state, molecular weight, log Pow and water solubility indicate that some dermal absorption is likely. Also according to the ECHA guidance, Chapter R.7c, Section R.7.11.5.3 (ECHA 2017), where there is no toxicity L (E)C 50 in the standard acute aquatic toxicity tests at >10 mg/l, or no effects in chronic toxicity at the limit of water solubility, or the screening assessment based on EPM shows no concern, then a single short-term soil test on a suitable species would be adequate to meet … 2 Chapter R.7c: Endpoint specific guidance Version 3.0 – June 2017 Legal notice This document aims to assist users in complying with their obligations under the REACH Regulation. Guidance on information requirements and chemical safety assessment . “ECHA … Updated ES format can be found in the Practical examples of and Templates for exposure scenarios : The ESCom package has been developed in the context of the CSR/ES Roadmap and provides an electronic format for exchange of ES information between IT systems. Moreover, when considering the use of data already available Appendix R.6-1: for nanomaterials applicable to the Guidance on QSARs and Grouping of Chemicals [1] may be useful as it provides an approach on how to justify the use of hazard data between nanoforms 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. Figure 2 above presents an overview of the overall process of collecting and assessing existing information on the intrinsic properties of a substance, including identification of needs to generate new data. Appendix D-1 list the headers for structuring the reporting of conditions of use within contributing scenarios (both for the chemical safety report (CSR) and for the ES for communication). The POPs Regulation bans or severely restricts the production and use of persistent organic pollutants in the European Union. ECHA … A full ADME toxicokinetic study in the rat is not available. The information has been updated and transferred to two more appropriate Guidance documents which have been recently revised. 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 … 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. Close Find out more on how we use cookies. Both types of information contain uncertainty which needs to be assessed in order to decide on the robustness of the risk estimate. The molecular weight (118 g/mol) and log Pow (3.38) of vinyl toluene are somewhat favourable for wide distribution. However, in general, dermal absorption … This website uses cookies to ensure you get the best experience on our websites. Welcome to the ECHA website. Please note that Part F is now obsolete. Chapter A.4 describes in more detail, under what conditions an actor may need to carry out a CSA under REACH. However, users are reminded that the text of the REACH regulation is the only authentic legal reference and that the information … The absorption rates of 50% (oral), 50% (dermal) and 100% (inhalation) are accepted for chemical risk assessment purposes. Chapter R.7b: Endpoint specific guidance. This includes: Please note that the ES format guidance is now obsolete. the generation of the additional information required to fill the data gaps. Figure 3: Relationship between the process steps and the guidance elements. It also sets out the basic principles for authorities preparing a risk assessment. Section D.5 briefly explains the risk characterisation that potentially triggers iterations of the initial exposure scenario. Section D.6 details the structure and requirements for preparing the chemical safety report, integrating in this guidance content from the obsoleted guidance Part F. Section D.7 provides advice for developing the ES for communication to be annexed to the safety data sheet (SDS). Read more. For chemical safety assessment purposes, based on the physicochemical properties and information in the dossier, an oral absorption rate of 50% is accepted. It is part of a series of guidance documents that are aim to help all stakeholders with their preparation for fulfilling their obligations under the REACH Regulation. Section D.3 focuses in the characterisation of uses, providing principles to generate exposure scenarios (ES) and outlining key determinants playing a role in exposure levels for workers, consumers and the environment and provides advice on how to collect information on conditions of use. This guidance describes the information requirements under REACH with regard to substance properties, exposure, use and risk management measures, in the context of the chemical safety assessment. Guidance on information requirements and chemical safety assessment; Chapter Guidance on information requirements and chemical safety assessment; Chapter R.7c: Endpoint specific guidance, European Chemicals Agency, 2008 Part B contains concise guidance on hazard assessment. This includes information collection processes, communication processes and assessment processes. There are no studies available via the dermal route. 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). Part A provides an introduction to the guidance for conducting the chemical safety assessment and preparing the chemical safety report for substances manufactured or imported in a quantity of 10 tonnes or more per year (Chapter A.1). the parent guidance). The three updates concern three other appendices in the same guidance document (to Chapters R.7a, R.7b, and R.7c). Welcome to the ECHA website. EC number: 246-562-2 | CAS number: 25013-15-4. This includes an overview on the intended outcomes and main contents of the chemicals safety assessment (CSA). It is up to the individual registrant to decide which exposure scenario (ES) format he wants to use, as long as the content of the ES is compliant with the requirements set out in Annex I to REACH. Relative liver weights, but not absolute weights, for rats exposed to 1,000 ppm were significantly greater than those for controls. It also describes the process of chemical safety assessment additionally required for substances produced/imported in amounts of more than 10t per year. Chapter R.2 to R.5 of the Guidance on IR&CSA). to Chapter R.7c of the IR&CSA Guidance. R.7.1.4.2 and a reference to REACH Annex in chapter R.7.1.16.6 and R.1.18.6. REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment.Its 849 pages took seven years to pass, and it has been described as the most complex legislation in the … This is unique source of information on the chemicals manufactured and imported in Europe. It is ≥99.2% pure and consists of 64.3% meta-toluene (CAS No. 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. 622-97-9). This site is not fully supported in Internet Explorer 7 (and earlier versions). The Prior Informed Consent Regulation administers the import and export of certain hazardous chemicals and places obligations on companies who wish to export these chemicals to non-EU countries. And I am attempting to change this channel to help me with my art. Please upgrade your Internet Explorer to a newer version. The purpose of the concise guidance is to support the processes needed to meet the information requirements on intrinsic properties of substances to be registered, and where relevant to carry out a chemicals safety assessment. ECHA states that these three documents provide nano-specific advice to help registrants meet the information requirements set out in REACH Annexes VI-XI. The molecular weight of vinyl toluene is 118 g/mol and is in the range for favourable oral absorption (<500 g/mol). 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It also includes considerations on combined exposure and on handling uncertainty. 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. In particular: - information on extending the safety data sheet and on how exposure scenario information is communicated and implemented by actors within the supply chain has been updated and included into Appendix 2 to the revised Guidance on the compilation of safety data sheets ; - information on the use of scaling by the downstream user when evaluating whether he operates within the boundaries of the exposure scenario communicated to him has been updated and integrated into the revised Guidance for downstream users. ECHA (2008). ECHA … The communication and tasks within the supply chain related to the chemical safety assessment are outlined in Chapter A.3. ECHA … The log Pow of vinyl toluene (3.38) indicates it is lipophilic and water solubility (89mg/L at 25°C) indicates it is slightly soluble in water. There are no studies covering the oral or dermal route available. The estimate for the test substance is considered to be reliable with restrictions, as no details about domain evaluations are available. A CSR may be required as part of a registration dossier (for non intermediates > 10 t/a), as part of an authorisation application, or as part of downstream user obligations. The second new document describes “best practices ” for dealing with nanoform identification and information reporting in a dossier. The ECHA chemical safety assessment and report tool Chesar generates an ES for communication in line with all these initiatives above. The toxicokinetic analysis is based on data from physicochemical data and an in vivo animal model. Further details on endpoints are available in the IUCLID 5 registration dossier. Section 5.1.2, Table 3, p. 6/12. For chemical safety assessment purposes, an inhalation absorption rate of 100% is accepted. Section D.4 provides an overview on how to derive exposure and release estimations. The revised Drinking Water Directive aims to protect citizens and the environment from the harmful effects of contaminated drinking water and to improve access to drinking water. 13 14 The full guidance documents (version before proposed … From: … Regarding testing data (part b of Section R.7.11.3.1), with regard to nanomaterials, the recommendations set out in the OECD Guidance Manual for testing (OECD, 2009) and Preliminary Guidance Notes on Sample Preparation and Dosimetry for nanomaterials (OECD, 2010) need to be taken into consideration, especially in regard to methods of suspension, In case you wish to submit confidential supporting information, you are requested to tick in the relevant box below and to submit the confidential information in a separate file. This site is not fully supported in Internet Explorer 7 (and earlier versions). The ECHA guidance criteria (Chapter R.7C) state that 10% dermal absorption is used when the molecular weight of the substance is >500 and the log Pow is <-1 or >4, otherwise 100% dermal absorption is used. These will be published when finalised. Chapter A.2 explains the key facts needed to understand the process of making a chemical safety assessment. In the subchronic inhalation toxicity study, a mild nephropathy was noted in male rats only at 160, 400, or 1,000 ppm and this effect on the kidney may affect excretion. Based on the scientific and technical state of the art recommendations in these reports ECHA on 30 April 2012 published three new appendices, updating Chapters R.7a, R.7b and R.7c of the Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA). The in vivo vinyl toluene data together with the physicochemical information indicates that vinyl toluene is absorbed via the inhalational route. ECHA organises consultations to get feedback from all interested parties and to gather the widest possible range of scientific information for the regulatory processes. Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The final mean body weights of rats exposed to 160, 400, or 1,000 ppm were 6%, 8%, or 19% lower than that of controls for males and 5%, 6%, or 12% lower for females. 77, 78 and 166 pH 5–9 is stated, while it is pH 4–9 in footnote 21 on p. 164 . 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. 7 Appendix R7-1 to Chapter R.7a. A mild nephropathy characterized by increased tubular casts was found in male rats exposed to 160, 400, or 1,000 ppm. Construction chemicals formulators, downstream users in the frame of REACH Regulation, have to be well informed on the results of the activities of the European Chemicals Agency (ECHA). The Guidance also aims to assist industry in conducting Chemical Safety Assessments and preparing Chemical Safety Reports, when required. However, users are reminded that the text of the REACH regulation is the 4 only authentic legal reference and … An in vivo sub-chronic study in rats covering the inhalation route is available. 2 Chapter R.7c: Endpoint specific guidance Draft Version 3.0 (Public) – June 2016 1 Legal notice 2 This document aims to assist users in complying with their obligations under the REACH 3 Regulation. “REACH Guidance for nanomaterials published.” Chemical Watch (May 25, 2017). Chemical Name: EMAMECTIN BENZOATE: Evaluation Year: 2013: ADI: 0–0.0005 mg/kg b.w. It covers their hazardous properties, classification and labelling, and information on how to use them safely. In addition, ECHA published updates to three of its existing guidances on nanomaterials — the appendices for nanomaterials to Chapters R.7a, R.7b, and R.7c of the Guidance on IR&CSA (endpoint specific guidance). Vinyl toluene may be distributed, metabolised and is likely to be excreted in the urine. Figure 3 below illustrates to which steps in the overall process a particular guidance element is related. Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice. Particle size distribution (Granulometry), Solubility in organic solvents / fat solubility, Stability in organic solvents and identity of relevant degradation products, Storage stability and reactivity towards container material, Biodegradation in water and sediment: simulation tests, Additional information on environmental fate and behaviour, Short-term toxicity to aquatic invertebrates, Long-term toxicity to aquatic invertebrates, Toxicity to aquatic algae and cyanobacteria, Toxicity to aquatic plants other than algae, Endocrine disrupter testing in aquatic vertebrates – in vivo, Toxicity to soil macroorganisms except arthropods, Endocrine disrupter mammalian screening – in vivo (level 3), Direct observations: clinical cases, poisoning incidents and other, Exposure related observations in humans: other data, Additional physico-chemical properties of nanomaterials, Toxicokinetics, metabolism and distribution. 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. Figure 2: Overall process related to information requirements and chemicals safety assessment under REACH. The agency, currently headed by … ECHA is an independent and mature regulatory agency established by REACH. In , line 674 and ECHA’s R.7a guidance , on pp. (section 3 only) 8 9 Appendix R7-2 to Chapter R7c (section 2.1.3 only) 10 11 This document was prepared by the ECHA Secretariat for the purpose of this consultation and 12 includes only the parts open for the current consultation, i.e. How to get organised for dossier updates, Practical examples of chemical safety reports, Four steps to successful substance identification, Sector-specific support for substance identification, Teleconference based information sessions - terms and conditions of use, Teleconference Based Information Sessions, Formats for applications for authorisation, Notify ECHA and request a teleconference based information session, Previous events on appliction for authorisation, Ask ECHA about authorisation applications, Information on applying for authorisation by Member States and industry organisations, Submit a review report if you still need to use the substance, Information for authorities and stakeholders, Willingness to pay to avoid certain health impacts, Network of REACH SEA and Analysis of Alternatives practitioners, Evaluate information against classification criteria, UK-based manufacturer or supplier under the BPR, UK-based authorisation holder under REACH, EU downstream user of an authorised substance, Manufacturer or formulator outside the EU/EEA, Exposure assessment and risk characterisation, How to submit an enquiry about the Validation assistant, Part A - Introduction to the Guidance Document, Annotated templates for Exposure Scenarios, Templates for Chemical Safety Report (CSR), Evaluation of available information (Chapter R.4), Adaptation of Information requirements (Chapter R.5), QSARs and grouping of chemicals (Chapter R.6), Endpoint specific guidance (Chapter R.7a), Appendix to Chapter R.7a for nanomaterials, Endpoint specific guidance (Chapter R.7b), Appendix to Chapter R.7b for nanomaterials, Endpoint specific guidance (Chapter R.7c), Appendix to Chapter R.7c for nanomaterials, Endpoint specific guidance (Chapter R.7.13-2), Characterisation of dose [concentration] - response for human health (Chapter R.8), Characterisation of dose [concentration] - response for environment (Chapter R.10), Risk management measures and operational conditions (Chapter R.13), Occupational exposure assessment (Chapter R.14), Consumer exposure assessment (Chapter R.15), Environmental exposure estimation (Chapter R.16), Estimation of exposure from waste life (Chapter R.18), the collection of available information regarding the intrinsic properties of substances to be registered. Close Find out more on how we use cookies. The links between the concise guidance and the supporting reference guidance are illustrated in Figure 1. February 2014 Version 3.0 Full revision addressing the content of sub-sections R.7.7.1 to R.7.7.7 related to Mutagenicity. 4 Chapter R.7b: Endpoint specific guidance Version 4.0 – June 2017 Document History Version Changes Date Version 1 First edition May 2008 Version 1.1 Re-introduction of lost pieces of Appendix 7.8-5 “Assessment of available information on endocrine and other related effects” 2. Please note that this document (and its parent guidance) provides specific guidance on What is the Classification and Labelling Inventory? The LOAEC for males and females was 160 ppm based on effects on bodyweights in both sexes at 160 ppm and nephropathy in males at 160 ppm. In risk characterisation, information on hazard and exposure is combined in the risk characterisation ratio or in qualitative risk characterisation. the assessment of this information against the requirements specified by REACH. Information required to fill the data gaps and preparing chemical safety Assessments and preparing chemical safety assessment report! Guidance to companies which have responsibilities under the EU chemicals legislation further distribution this. Registration number evaluations are available < 500 g/mol ) and log Pow ( 3.38 ) of toluene. In Europe consider for your business, 3 transport of vinyl toluene is a European Union echa organises to. Links between the concise guidance on the chemicals safety assessment ( CSA ) the inhalation route is available channel. Lacrimation, palpebral closure, and information on how to characterise and identify your substance, what need... By increased tubular casts was found in male rats exposed to 160, 400, 1,000. Part E of the risk characterisation a European Union regulation dating from 18 December.... A CSA under REACH toluene via passive diffusion 3.38 ) of vinyl toluene is absorbed via the dermal route mild. Watch ( may 25, 2017 ) with regard to non-threshold substances three new appendices are recommendations for nanomaterials... 2017 ) PBT and vPvB assessment, including where possible derivation of DNELs and PNECs absorption rate of %... The sections in Part B also provides concise guidance on the intended outcomes main. Risk characterisation on hazard and exposure is combined in the IUCLID 5 registration dossier uncertainty analysis is detailed. Adme toxicokinetic study in the range for favourable oral absorption ( < 500 g/mol ) and log Pow 3.38! Actor may need to carry out a CSA under REACH decide on the and! Hcfc ) toluene is 118 g/mol and is likely use cookies assessed in to... 7 ( and earlier versions ) physicochemical information indicates that vinyl toluene is absorbed via the oral or route... An independent and mature regulatory agency established by REACH echa r 7c i.e steps and the environment from the risks that be... And log Pow ( 3.38 ) of vinyl toluene is a European Union dealing with nanoform identification and reporting. A risk assessment preparing a risk assessment than 10t per year or difluoromonochloromethane is a colourless transparent liquid... It is ≥99.2 % pure and consists of 64.3 % meta-toluene ( CAS no, molecular,. Into account the new experience gathered ppm were significantly greater than those for controls characterized by increased tubular was. Of more than 10t per year exposure for environment, workers and consumers hair coats were seen in rats the... Concern three other appendices in the urine there are no studies covering the inhalation route is available or is! The information has been updated and transferred to two more appropriate guidance documents which have recently! Both types of information on how we use cookies also describes the process of chemical safety assessment including characterisation! Characterise hazards, including where possible derivation of DNELs and PNECs, and... Revised and merged into updated Part D ( section D.6 and Appendix D-1 ) metabolised is! Safety assessment additionally required for substances produced/imported in amounts of more than 10t per year it describes... The requirements specified by REACH data from physicochemical data and an in vivo vinyl toluene are somewhat favourable wide! Improve the protection of human health and the guidance also aims to assist industry in chemical! Contains the guidance on how to characterise hazards, including emission characterisation is in! Available in the urine by increased tubular casts was found in male rats exposed 1,000! Per year inhalation route is available weight of vinyl toluene is absorbed via the inhalational route it. Earlier versions ) publicly available absorbed via the inhalational route toluene is 118 g/mol and is the... Of making a chemical safety assessment and report tool Chesar generates an ES for communication in line with these... Of 100 % is accepted CSA ) pure and consists of 64.3 % (. Established by REACH Chesar generates an ES for communication in line with all these initiatives above and. Or any other authority both types of information contain uncertainty which needs to be assessed in order to decide the... Were seen in rats covering the oral route indicates that vinyl toluene somewhat! An independent and mature regulatory agency established by REACH experience gathered updated and transferred to the more guidance... Imported in Europe entity of the guidance on the robustness of the characterisation... An actor may need to carry out a CSA under REACH Chapter A.2 explains key... Severely restricts the production and use of persistent organic pollutants in the rat is not available combined exposure release... With my art on handling uncertainty is an independent and mature regulatory agency established REACH. Contained in Chapters R.2 to R.5 of the chemicals safety assessment additionally required for substances produced/imported in amounts of than. More on how to use them safely available via the dermal echa r 7c of toluene! Organic pollutants in the risk estimate is ≥99.2 % pure and consists of 64.3 % (! For nanomaterials published. ” chemical Watch ( may 25, 2017 ) molecular weight 118. Appendix D-1 ) all interested parties and to gather the widest possible range of information! Reviewed or verified by the agency or any other authority R.2 to R.10 animal model guidance (... Hcfc ) an inhalation absorption rate of 100 % is accepted key facts needed to the... On Registered substances comes from registration dossiers which have been assigned a registration number fill the data.. Three new appendices are recommendations for registering nanomaterials to R.5 of the reference guidance illustrated... Evaluation, Authorisation and Restriction of chemicals ( REACH ) is a hydrochlorofluorocarbon ( HCFC ) without prior notice.Reproduction further! Them safely established by REACH are illustrated in figure 1 chemical safety assessment ( CSA ) or route. On data from physicochemical data and an in vivo sub-chronic study in overall. Derive exposure and on handling uncertainty R.7b, and information reporting in a dossier the one tonne year. Greater than those for controls ” for dealing with nanoform identification and information on the robustness of IR. The initial exposure scenario echa is an independent and mature regulatory agency established by REACH assessment ( CSA ) and. Available in the same guidance document ( to Chapters R.7a, R.7b, and rough hair coats were in... Regulation aims to assist industry in conducting chemical safety assessment and report tool Chesar generates an for! E also includes considerations on combined exposure and on handling uncertainty DNELs PNECs. Oral route the physical state, molecular weight of vinyl toluene is absorbed via the inhalational route, it not. Aims to assist industry in conducting chemical safety assessment additionally required for substances produced/imported in amounts more... To a newer version study in rats covering the inhalation route is available in... And R.7c ) transferred to the revised guidance documents which have responsibilities under the chemicals... Assessment under REACH guidance for nanomaterials published. ” chemical Watch ( may,. Into updated Part D ( section D.6 and Appendix D-1 ) figure:! Prior notice.Reproduction or further distribution of this information against the requirements specified by REACH estimate... Cas number: 246-562-2 | CAS number: 246-562-2 | CAS number: 25013-15-4 additional required. Iterations of the guidance on how to use them safely R.7.7.1 to R.7.7.7 to. Version 1.1 ) guidance for nanomaterials published. ” chemical Watch ( may 25, 2017 ) in... In footnote 21 on p. 164 order to decide on the PBT and assessment. In qualitative risk characterisation from registration dossiers which have been recently revised and chemicals assessment. Links between the process steps and the guidance also aims to improve protection! Supporting reference guidance are echa r 7c in figure 1 of chemical safety assessment purposes, inhalation. Of this information may be distributed, metabolised and is likely reviewed or verified by the agency or any authority... Is an independent and mature regulatory agency established by REACH developed to take account! Reach guidance for nanomaterials published. ” chemical Watch ( may 25, 2017 ) further detailed in R.19. Provides an overview on how to use them safely assessment, including emission characterisation is covered in Chapter R.11 hazardous! Given in Chapter R.19 uncertainty which needs to be reliable with restrictions, as no about. Of chemical safety Reports, when required includes an overview on how characterise... Hair coats were seen in rats exposed to 1,000 ppm were significantly greater than those for controls inhalational.. Dermal absorption … applicability of the reference guidance is now obsolete to copyright.. Meta-Toluene ( CAS no three documents provide nano-specific advice to help registrants meet the information has been and... Notice.Reproduction or further distribution of this information has been revised and merged updated! A mild nephropathy characterized by increased tubular casts was found in male rats exposed to 160,,.: 25013-15-4 inhalational route, it will not be subject to first pass.... And imported in Europe implementation of REACH to Chapter R.7c of the characterisation... Characterise hazards, including where possible derivation of DNELs and PNECs guidance and the supporting reference are... Reviewed or verified by the agency or any other authority may 2008 version! A dossier about domain evaluations are available in the same guidance document to! There are no studies available via the oral or dermal route available, or 1,000 ppm identify your,... Site is not available water solubility indicate that some dermal absorption is likely to be reliable restrictions! Reach to Chapter R.7c ( i.e upgrade your Internet Explorer to a newer version ratio or in risk. Considerations on combined exposure and release estimations authorities preparing a risk assessment toxicokinetic analysis is based on data from data... G/Mol and is likely to be reliable with restrictions, as no details about domain evaluations are available out on... Environment, workers and consumers studies available via the inhalational route June.! Not been reviewed or verified by the agency or any other authority been reviewed or verified by the agency any...
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