Scientific Committee On Occupational Exposure Limits Research Articles

Health Risk Assessment of Ortho-Toluidine Utilising Human Biomonitoring Data of Workers and the General Population.

The aim of this work was to demonstrate how human biomonitoring (HBM) data can be used to assess cancer risks for workers and the general population. Ortho-toluidine, OT (CAS 95-53-4) is an aniline derivative which is an animal and human carcinogen and may cause methemoglobinemia. OT is used as a curing agent in epoxy resins and as intermediate in producing herbicides, dyes, and rubber chemicals. A risk assessment was performed for OT by using existing HBM studies. The urinary mass-balance methodology and generic exposure reconstruction PBPK modelling were both used for the estimation of the external intake levels corresponding to observed urinary levels. The external exposures were subsequently compared to cancer risk levels obtained from the evaluation by the Scientific Committee on Occupational Exposure Limits (SCOEL). It was estimated that workers exposed to OT have a cancer risk of 60 to 90:106 in the worst-case scenario (0.9 mg/L in urine). The exposure levels and cancer risk of OT in the general population were orders of magnitude lower when compared to workers. The difference between the output of urinary mass-balance method and the general PBPK model was approximately 30%. The external exposure levels calculated based on HBM data were below the binding occupational exposure level (0.5 mg/m3) set under the EU Carcinogens and Mutagens Directive.

CORRIGENDUM

AllergyVolume 75, Issue 8 p. 2146-2147 CORRIGENDUMFree Access CORRIGENDUM This article corrects the following: Food processing and occupational respiratory allergy- An EAACI position paper Mohamed F. Jeebhay, Gianna Moscato, Berit E. Bang, Ilenia Folletti, Agnieszka Lipińska-Ojrzanowska, Andreas L. Lopata, Gianni Pala, Santiago Quirce, Monika Raulf, Joaquin Sastre, Ines Swoboda, Jolanta Walusiak-Skorupa, Andrea Siracusa, Volume 74Issue 10Allergy pages: 1852-1871 First Published online: June 23, 2019 First published: 27 July 2020 https://doi.org/10.1111/all.14232AboutReferencesRelatedInformationPDFPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessClose modalShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL In the article,1 there were typesetting errors in Table 5 on page 1862. In the rows, Floor dust, Penicillium, and Tea dust, the superscript “c” should have been corrected to “b” for the following countries: Israel, South Korea, Canada Ontario, Norway, Spain, Sweden and China. In 6th row, Proteolytic enzymes, “suatilisins” was incorrect and should have been changed to “subtilisins.” The correct Table 5 should be: Table 5. List of occupational exposure limits (OELs) for allergens in the food processing industry Food substance OEL (8-h time weighted average, total fraction, unless otherwise specified) Country Grain dust 1 mg/m3 4 mg/m3 5 mg/m3 10 mg/m3 Short term: 10 mg/m3 Japana Austriab, Belgium, Canada (Ontario), Canada (Quebec), Japan, Chinab, Singapore, South Korea, Spain, USA (NIOSH, ACGIH) Austria Ireland, USA (CAL OSHA), UK, South Africa Austriac Flour dust 0.5 mg/m3 1 mg/m3 2 mg/m3 3 mg/m3 4 mg/m3 6 mg/m3 10 mg/m3 Short term: 8 mg/m3 30 mg/m3 Belgium, Israelb, South Koreab, USA (ACGIH, CAL OSHA) Ireland, EU (SCOEL) Finland Canada (Ontario)b, Sweden, Norwayb Austria, Spainb Latvia UK Austriac UKd Penicillium 0.1 mg/m3 Swedenb Tea dust 2 mg/m3 3 mg/m3 Chinab Latvia Poultry dust 10 mg/m3 Canada (Ontario) Proteolytic enzymes (subtilisins, 100% pure crystalline) 15 ng/m3 40 ng/m3 60 ng/m3 1 glycine unit/m3 Short term: 30 ng/m3 60 ng/m3 3 glycine unit/m3 China UK Belgium, Denmark, Ireland, USA (NIOSH)d Swedene Chinad Australiaf, Canada (Ontario)f, Canada (Quebec)f, Denmarkf, Irelandd, New Zealandf, Singapored, Spaind, Switzerlandd, USA (ACGIH)f, USA (NIOSH)g, Norwayf Swedend,e Sources: - National Institute for Occupational Safety and Health (NIOSH): Recommended Exposure Limit (REL), https://www.cdc.gov/niosh/npg/default.html - American Conference of Governmental Industrial Hygienists (ACGIH): Threshold Limit Value (TLV), ISBN 978-1-607260-90-5 - Occupational Safety and Health Administration, California (CAL/OSHA): legal Permissible Exposure Limit (PEL), http://www.dir.ca.gov/title8/5155table_ac1.html#_blank - European Union (EU): European Commission Scientific Committee on Occupational Exposure Limits (SCOEL): http://ec.europa.eu/social/main.jsp?catId=148&intPageId=684&langId=en - Norwegian Ministry of Labour and Social Affairs. https://lovdata.no/dokument/SF/forskrift/2011-12-06-1358 - National Institute for Public Health and the Environment The Netherlands. RIVM Letter report 2014-0151,© RIVM 2014 - Health and Safety Executive (HSE). 2nd edition. ISBN 978 0 7176 6446 7 - OSHA 2017. https://www.osha.gov/dsg/annotated-pels/tablez-1.html Annotations: arespirable fraction, binhalable fraction, c30-min average, d15-min average, eone glycine unit is approximately equivalent to 30 ng of pure subtilisin, fceiling limit value, and g60-min average. REFERENCE 1Jeebhay MF, Moscato G, Bang BE, et al. Food processing and occupational respiratory allergy - An EAACI position paper. Allergy. 2019; 74(10): 1852- 1871. Volume75, Issue8August 2020Pages 2146-2147 ReferencesRelatedInformation RecommendedFood processing and occupational respiratory allergy‐ An EAACI position paperMohamed F. Jeebhay, Gianna Moscato, Berit E. Bang, Ilenia Folletti, Agnieszka Lipińska-Ojrzanowska, Andreas L. Lopata, Gianni Pala, Santiago Quirce, Monika Raulf, Joaquin Sastre, Ines Swoboda, Jolanta Walusiak-Skorupa, Andrea Siracusa, Allergy

4,4’- Isopropylidenediphenol – inhalable fraction. Documentation of proposed values of occupational exposure limits (OELs)

4,4’- Isopropylidenediphenol – inhalable fraction. Documentation of proposed values of occupational exposure limits (OELs)

Nitroethane Documentation of proposed values of occupational exposure limits (OELs)

Nitroethane is a colorless oily liquid with a mild fruity odor. It is used mainly as a pro-pellant (e.g., fuel for rockets), and as a solvent or dissolvent agent for cellulose esters, resins (vinyl and alkyd) and waxes, and also in chemical synthesis.Occupational exposure to nitroethane may occur during the process of its production and processing. There are no data on air concentra-tions of nitroethane in occupational exposure. In 2010–2015, workers in Poland were not exposed to nitroethane concentrations exceed-ing the maximum allowable value – 75 mg/m3 (the limit value valid since 2010).Nitroethane can be absorbed into the body via inhalation of its vapors or by ingestion.The discussed cases of nitroethane acute poi-soning caused by an accidental ingestion of artificial fingernail remover containing pure nitroethane concerned children under three years. Few hours after ingestion, cyanosis and sporadic vomiting were observed in children. The methemoglobin level reached 40÷50%.Neither data on chronic nitroethane poisoning in humans nor data obtained from epidemio-logical studies are available.On the basis of the results of acute toxicity studies nitroethane has been categorized in the group of hazardous compounds. However, eye and dermal irritation or allergic effects have not been evidenced. The studies of sub-chronic (4 and 90 days) and chronic (2 years) exposure to nitroethane per-formed on rats and mice (concentration range 310 ÷ 12 400 mg/m3) revealed the methemo-globinogenic effect of this compound and a minor damage to liver, spleen, salivary gland and nasal turbinates.Niroethane has shown neither mutagenic nor carcinogenic effects. Its influence on fertility has not been evidenced either. After chronic exposure (2 years) of rats to ni-troethane at concentration of 525 mg/m3 (the lowest observed adverse effect level – LOAEL), a slight change in a body mass of exposed fe-male animals and subtle changes in biochemi-cal parameters were observed, but there were no anomalies in hematological and histopatho-logical examinations.The value of 62 mg/m3 has been suggested to be adopted as the MAC value for nitroethane after applying the LOAEL value of 525 mg/m3 and relevant coefficients of uncertainty. The STEL value for nitroethane was proposed ac-cording to the methodology for determining short term exposure level value for irritating substances as three times MAC value (186 mg/m3) to prevent the effects of sensory irri-tations in humans. Because of its methemoglo-binogenic effect, 2% Met-Hb has been suggest-ed to be adopted as the value of biological ex-posure index (BEI), like the value already adopted for all methemoglobinogenic sub-stances.The Scientific Committee on Occupational Exposure Limits (SCOEL) proposed the time-weighted average (TWA) for nitroethane (8 h) as 62 mg/m3 (20 ppm), short-term exposure limit (STEL, 15 min) as 312 mg/m3 (100 ppm) and “skin” notation.Proposed OEL and STEL values for nitroethane were subjected to public consultation, con-ducted in 2011 by contact points, during which Poland did not raise any objections to the pro-posals. The proposed values for nitroethane by SCOEL has been adopted by the Advisory Committee on Safety and Health at Work UE (ACSH) and included in the draft directive establishing the IV list of indicative occupa-tional exposure limit values.

Outcome of the consultation with Member States and EFSA on the basic substance application for calcium hydroxide and the conclusions drawn by EFSA on the specific points raised

EFSA Supporting PublicationsVolume 10, Issue 10 488E Technical reportOpen Access Outcome of the consultation with Member States and EFSA on the basic substance application for calcium hydroxide and the conclusions drawn by EFSA on the specific points raised European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author First published: 18 October 2013 https://doi.org/10.2903/sp.efsa.2013.EN-488Citations: 1 Published date: 18 October 2013 Question number: EFSA-Q-2013-00402 AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat References Anonymous, 2003. Title: Calcium balance in orchards on different soil types, treated with calcium hydroxide against fruit tree canker Source: Request to amend Annex IIB-Pesticides, Annex I. van Rooijen, H, 2006. Title: Evaluation of calcium hydroxide and anti-clotting agents in surface water. Source: Hoogheemraadschap De Stichtse Rijnlanden, Houten (NL). Evaluation based on the criteria in CIW report “Het beoordelen van stoffen en preparaten voor de uitvoering van het emissiebeleid water” (judgement of substances and preparations in the framework of emission management water). Details of the evaluation not available. Schärer, HJ. A., Häseli, C., Daniel, J., Fuchs, L., Tamm; 2010. Title: Praxisversuche 2010 mit Löschkalk und Hanfextrakt gegen Feuerbrand. Source: Öffentlicher Schlussbericht 2010. SCOEL (Scientific Committee on Occupational Exposure Limits), 2008. Recommendation from the Scientific Committee on Occupational Exposure Limits for Calcium oxide (CaO) and calcium hydroxide (Ca(OH)2). SCOEL/SUM/137. February 2008. Citing Literature Volume10, Issue10October 2013488E ReferencesRelatedInformation

Comparing the safety margins in the European indicative occupational exposure limits and the derived no-effect levels under reach

The new European Union (EU) REACH legislation requires Derived No-Effect Levels (DNEL) to be calculated for substances produced in quantities above 10 tonnes/year. Workers are one population that these DNELs are to protect. Meanwhile, the setting of occupational exposure limits (OEL) continues both at the member state and the EU level. Health-based OELs are proposed by the Commission's Scientific Committee on OELs (SCOEL) and eventually result in Indicative OEL Values (IOELV) in EU Directives. According to REACH, IOELVs may under some circumstances be used as worker-DNELs. On the other hand, worker-DNELs will be derived for several thousand substances, far more than the roughly 100 substances for which IOELVs have been established. Thus, the procedure to set health-based OELs may become influential on that of DNELs and vice versa. This study presents a comparison of the safety margins of 88 SCOEL recommendations with those of the corresponding worker-DNELs, derived according to the REACH guidance document. Overall, the REACH safety margins were approximately six times higher than those derived from the SCOEL documentation but varied widely with REACH/SCOEL ratios ranging by two orders of magnitude, from 0.3 to 58. It was also found that the REACH guidance document, although encompassing detailed advice on many issues, including default assessment factors for species and route extrapolation, gives no quantitative guidance on when and how to depart from defaults.

A Quantitative Comparison of the Safety Margins in the European Indicative Occupational Exposure Limits and the Derived No-Effect Levels for Workers under REACH

The new European Union (EU) REACH legislation requires derived no-effect levels (DNELs) to be calculated for substances produced in quantities above 10 tonnes/year. Meanwhile, the setting of occupational exposure limits (OELs) continues both at the member state and the EU levels. According to REACH, indicative OEL values (IOELVs) from the Commission may under some circumstances be used as worker-DNELs. On the other hand, worker-DNELs will be derived for several thousand substances, far more than the approximately 100 substances for which IOELVs have been established. Thus, the procedure to set health-based OELs may become influential on that of DNELs and vice versa. In this study, we compare the safety margins of 88 Scientific Committee on OELs (SCOEL) recommendations with those of the corresponding worker-DNELs, derived according to the default approach as described in the REACH guidance document. Overall, the REACH safety margins were approximately six times higher than those derived from the SCOEL documentation but varied widely with REACH/SCOEL safety margin ratios ranging by two orders of magnitude, from 0.3 to 58 (n = 88). The discrepancies may create confusion in terms of legal compliance, risk management, and risk communication. We also found that the REACH guidance document, although encompassing detailed advice on many issues, including default assessment factors for species and route extrapolation, gives little quantitative guidance on when and how to depart from defaults.

The Concept of “Practical Thresholds” in the Derivation of Occupational Exposure Limits for Carcinogens by the Scientific Committee on Occupational Exposure Limits (SCOEL) of the European Union

In Europe, there has been a scientific discussion on possible thresholds in chemical carcinogens since the late 1990s. Based on this discussion, the Scientific Committee on Occupational Exposure Limits (SCOEL) of the European Union has discussed a number of chemical carcinogens and has issued recommendations. For some carcinogens, health-based Occupational Exposure Limits (OELs) were recommended, while quantitative assessments of carcinogenic risks were performed for others. For purposes of setting OELs the following groups of carcinogens were adopted: (A) Non-threshold genotoxic carcinogens; for low-dose assessment of risk, the linear non-threshold (LNT) model appears appropriate. For these chemicals, the risk management may be based on the ALARA principle (”as low as reasonably achievable”), technical feasibility, and other socio-political considerations. (B) Genotoxic carcinogens, for which the existence of a threshold cannot be sufficiently supported at present. In these cases, the LNT model may be used as a default assumption, based on the scientific uncertainty, and the ALARA principle may be applied as well. (C) Genotoxic carcinogens with a practical threshold is supported by studies on mechanisms and/or toxicokinetics; health-based exposure limits may be based on an established no-observed adverse effect level (NOAEL). (D) Non-genotoxic carcinogens and non DNA-reactive carcinogens; for these compounds a true (”perfect”) threshold is associated with a clearly founded NOAEL. The mechanisms shown by tumor promoters, spindle poisons, topoisomerase II poisons and hormones are typical examples of this category. Health-based OELs are derived for carcinogens of Groups C and D, while a risk assessment is carried out for carcinogens of Groups A and B. In order to highlight the most important differentiation between Groups B and C, the basic reasoning is given for the six compounds formaldehyde, vinyl acetate, acrylonitrile, acrylamide, trichloroethylene and methylene chloride.

Strategy of the scientific committee on occupational exposure limits (SCOEL) in the derivation of occupational exposure limits for carcinogens and mutagens

Setting standards, such as occupational exposure limits (OELs) for carcinogenic substances must consider modes of action. At the European Union level, the scientific committee on occupational exposure limits (SCOEL) has discussed a number of chemical carcinogens and has issued recommendations. For some carcinogens, health-based OELs were recommended, while quantitative assessments of carcinogenic risks were performed for others. For purposes of setting limits this led to the consideration of the following groups of carcinogens. (A) Non-threshold genotoxic carcinogens; for low-dose assessment of risk, the linear non-threshold (LNT) model appears appropriate. For these chemicals, regulations (risk management) may be based on the ALARA principle ("as low as reasonably achievable"), technical feasibility, and other socio-political considerations. (B) Genotoxic carcinogens, for which the existence of a threshold cannot be sufficiently supported at present. In these cases, the LNT model may be used as a default assumption, based on the scientific uncertainty. (C) Genotoxic carcinogens with a practical threshold, as supported by studies on mechanisms and/or toxicokinetics; health-based exposure limits may be based on an established NOAEL (no observed adverse effect level). (D) Non-genotoxic carcinogens and non-DNA-reactive carcinogens; for these compounds a true ("perfect") threshold is associated with a clearly founded NOAEL. The mechanisms shown by tumour promoters, spindle poisons, topoisomerase II poisons and hormones are typical examples of this category. Health-based OELs are derived for carcinogens of groups C and D, while a risk assessment is carried out for carcinogens of groups A and B. Substantial progress is currently being made in the incorporation of new types of mechanistic data into these regulatory procedures.

Setting occupational exposure limits for sensory irritants: the approach in the European Union.

Beginning in 1990, the European Commission initiated a program to establish European Union (EU)-wide occupational exposure limits (OELs). As in the United States and other countries, a panel of experts known as the Scientific Committee on Occupational Exposure Limits (SCOEL) was identified and brought together to identify the proper values. This article describes the approach used by SCOEL to identify appropriate values for sensory irritants. The EU panel believes that irritant effects in the eyes and respiratory tract can produce symptoms that range from trivial to serious, and that responses to irritants may be viewed as belonging to a continuum. One of the interesting differences between the approach used by the ACGIH TLV committee and the SCOEL is the use of five grades of irritation to evaluate this class of chemicals. For purposes of setting an OEL, the SCOEL makes no distinction between irritation or nuisance and related somatic effects such as headache. How the committee established an OEL for ethyl acetate is offered as an illustrative example.