Classification , Labelling And Packaging Research Articles

Regenerative and progressing lesions in lungs and lung-associated lymph nodes from fourteen 90-day inhalation studies with chemically different particulate materials

Rat lungs and lung-associated lymph nodes from 14 inhalation studies with chemically different particulate materials were histopathologically re-evaluated, and the bronchoalveolar lavage fluid (BALF) data and lung burden analyses were compared. All investigated substances caused similar lesions. For most substances, 1 mg/m3 of respirable particulate matter was established as the borderline for adverse morphological changes after the 90-day exposure period, confirmed by the increase in polymorphonuclear neutrophils in BALF. Possible reversibility was demonstrated when recovery groups are included in the study especially allowing the differentiation between regeneration or progressing of inflammatory changes during the recovery period. It was concluded, that the major driver of toxicity is not an intrinsic chemical property of the particle but a particle effect. Concerning classification for specific target organ toxicant (STOT) repeated exposure (RE), this paper highlights that merely comparing the lowest concentration, at which adverse effects were observed, with the Classification Labelling and Packaging (CLP) regulation (EC) no. 1272/2008 guidance values is inappropriate and might lead to a STOT classification under CLP for a large part of the substances discussed in this paper, on the basis of typically mild to moderate findings in rat lung and lung-associated lymph nodes on day 1 after exposure. An in-depth evaluation of the pathologic findings is required and an expert judgement has to be included in the decision on classification and labeling, evaluating the type and severity of effects and comparing these with the classification criteria.

Occurrence Characterization and Contamination Risk Evaluation of Microplastics in Hefei’s Urban Wastewater Treatment Plant

As one of the primary nodes in the flow of micro-plastics (MPs) in the environment, it is critical to examine and assess the Sewage Treatment, occurrence, and removal of MPs in waste treatment plant (WWTP). This research explored the shape, size, and composition of MPs at various stages of the WWTP process in the south of the city of Hefei, China, in dry and rainy weather conditions, as well as the removal effectiveness of MPs in a three-stage process. The collected MPs were quantitatively and qualitatively examined using an Osmosis electron microscope and micro-FTIR. The pollution risk of MPs in WWTP was assessed using the EU classification, labelling and packaging (CLP) standard and the pollution load index (PLI). The findings revealed that the average abundance of fibrous MPs was greatest in WWTP sewage and sludge, 49.3% and 39.7% in dry weather, and 50.1% and 43.2% in rainy weather, respectively. The average distribution of MPs in the 0–500 μm range was highest in WWTP wastewater and sludge, 64.9% and 60.4% in dry weather and 67.9% and 69.0% in rainy weather, respectively. Finally, the overall removal rate was 87.7% and 83.5%. At the same time, it has been demonstrated that MPs with varied compositions are strongly tied to human activities, and environmental conditions (such as rainy weather) also influence their source. In both dry and wet weather, the amount of polymers and the risk score were linked to the pollution risk of MPs in WWTP. In wet weather, the MPS pollution index was more variable. The pollution indices of MPs in row water and tail water were 2.40 and 2.46, respectively, which were heavily contaminated, and 1.0 and 1.2, which were moderately polluted. MPs in dewatered sludge had severely polluted indexes of 3.5 and 3.4, respectively. As a result, there is still MPs efflux or buildup in sludge during and after the WWTP process, which presents an ecological contamination concern.

Identification of substances with a carcinogenic potential in spray-formulated engine/brake cleaners and lubricating products, available in the European Union (EU) – based on IARC and EU-harmonised classifications and QSAR predictions

Spray-formulated engine/brake cleaners and lubricating agents are widely used to maintain machines. The occupational exposure to their aerosols is evident. To assess the carcinogenic potential of these products, we identified such products available in the European Union (EU). We built a database with CAS numbers of 1) mono-constituent substances, and 2) multi-constituent-substances, and unknown-or-variable-composition,-complex-reaction-products-and-biological-materials (multi-constituent/UVCBs). The compositions of multi-constituent/UVCBs were unravelled with European Chemicals Agency (ECHA) registration dossiers. To identify carcinogenic potentials, we searched for 1) International Agency for Research on Cancer (IARC) classification; 2) Harmonised classifications in Annex VI to the EU classification, labelling and packaging (CLP) Regulation; and 3) whether they had a Danish Environmental Protection Agency advisory CLP self-classification based on quantitative structure-activity relationships (QSARs) for genotoxicity and carcinogenicity in the Danish (Q)SAR Database. In 82 products, we identified 332 mono-constituent substances and 44 multi-constituent/UVCBs. Six substances were either IARC 1 or 2B classified. Twelve mono-constituent substances and 22 multi-constituent/UVCBs had harmonised classifications as Carcinogenic Category 1A, 1B or 2, while nine substances fulfilled the QSAR-based advisory self-classification algorithms for mutagenicity or carcinogenicity. At the product level, 39 products contained substances of carcinogenic concern by either IARC, harmonised classification or QSAR. We conclude that in the investigated EU marketed spray-formulated engine/brake cleaners and lubricants, 24 of 332 mono-constituent substances and 28 of 44 multi-constituent/UVCBs had a carcinogenic potential. At the product level, 39 of 82 contained substances with an identified carcinogenic potential. Regulators and manufacturers can use this determination of carcinogenic potential to decrease occupational risk.

Quantification of preservatives in tattoo and permanent make-up inks in the frame of the new requirements under the REACH Regulation.

According to the REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) restriction, tattoo and permanent make-up (PMU) inks placed on the European Union market after January 4, 2022, shall not contain methylisothiazolinone, benzisothiazolinone (BIT), octylisothiazolinone (OIT), or other skin sensitizers in concentrations of 10 mg/kg or higher and phenoxyethanol (PE) or other eye irritants or damaging substances in concentrations of 100 mg/kg or higher. In addition, preservatives and other substances enlisted in Annex II to Cosmetic Product Regulation shall not be present in concentrations of 0.5 mg/kg or higher. This study aims to quantify 14 preservatives in 99 tattoo and 39 PMU inks from the Italian market and presents a comparison with concentration limits set by the REACH restriction. Inks were analysed by applying validated analytical methods based on liquid chromatography techniques. About 24.0%, 15.2% and 1.5% of the overall samples contained BIT, PE and OIT, respectively, at concentrations exceeding REACH concentration limits. The number of noncompliant tattoo inks (49.5%) would be significantly greater than that of the PMU inks (17.9%). About 40.6% of the samples would be noncompliant with the restriction for the presence of preservatives above the permitted level. Additional concentration limits will apply to skin sensitizing preservatives for proper labelling of inks under CLP (Classification, Labelling and Packaging) Regulation.

Cobalt–Chromium Dental Alloys: Metal Exposures, Toxicological Risks, CMR Classification, and EU Regulatory Framework

During the 20th century, metal alloys have assumed an important role as restorative materials. Among existing examples, cobalt–chromium (Co–Cr) alloys increasingly began to be used in medicine and especially in dentistry. Their success is mainly due to their mechanical properties such as stiffness, strength and corrosion resistance, thus allowing a high biocompatibility. There are quite meaningful data on the corrosion and toxicity of Co–Cr alloys for their use in restorative materials such as dental prostheses. Toxicological studies following Co and Cr exposures in the oral cavity are more difficult to conduct because there are many different situations leading to the release of metal ions and wear particles. Furthermore, the links between exposure and the appearance of local or systemic toxicity are not automatic. Since 2017, the European Union (EU) regulatory framework for Co–Cr alloys has been undergoing profound changes. A new EU Medical Devices Regulation (MDR) (2017/745) will be applied in May 2021 with the need to consider that Co metal is a new carcinogenic, mutagenic and toxic to reproduction (CMR) substance. On 18 February 2020, the 14th Adaptation to Technical Progress (ATP14) to the Classification, Labelling and Packaging (CLP) regulation was published, including the harmonised classification for Co metal as a CMR 1B substance. In this context, the use of Co might be forbidden if the medical devices are invasive and as soon as they include more than 0.1% (m/m) Co. This review provides a specific overview on Co–Cr dental alloys in terms of metal ions and wear particles release, toxicological risks, and the actual and new EU regulatory framework.

Group Contribution Method to Estimate the Biodegradability of Organic Compounds

The study of biodegradation of chemicals that are discharged into water bodies is important to determine the risk to the environment that is associated with the chemical. The biodegradability of a chemical can be characterized by conventional oxidation parameters such as biochemical oxygen demand (BOD), chemical oxygen demand (COD), and theoretical oxygen demand. Because the BOD5 estimation method takes five days, other methods have been sought for measuring oxygen requirements of a sample. One of them is the COD test which makes use of a strong oxidizing agent under acidic conditions. In this paper, a combination of BOD5 and COD experimental data is used to develop a quantitative model for the prediction of biodegradability. Furthermore, the criterion used to classify a substance as “readily biodegradable” is the one specified by the European Chemical Agency (EChA)’s CLP (Classification, Labeling, and Packaging) Regulation.

Is It Safe to Paint Your Wall White? A Case Study on Titanium Dioxide Classification.

Titanium dioxide (TiO2 ) is in the process of being classified as a suspected carcinogenic substance (Carc 2). The present case study probes the outcomes of this potential classification in terms of the reduction of hazardous exposure to TiO2 due to its classification. Furthermore, the case study examines the elements that are causing ambiguity during the classification process. This study was conducted by walking through the process from the present exposure to TiO2 to the hazard assessment associated with TiO2 exposure, to the regulatory classification process, and to practical outcomes affecting TiO2 usage. Finally, the impact of the classification on exposure, which was originally considered potentially hazardous, is evaluated. The case study shows that TiO2 classification as a carcinogen will not directly reduce respiratory exposure to TiO2 , which was the original reason for the classification. Instead, the classification will lead to restrictions on recycling. Moreover, the classification will have an impact on certain solid artifacts and liquid mixtures for which hazardous exposure was not detected. Altogether, the present case raises questions concerning hazard communications associated with the Carc 2 classification; treatment of poorly soluble low toxicity (PSLT) particles and nanoparticles in the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and the Classification, Labelling and Packaging (CLP) classifications; and use of human exposure studies for the purposes of chemical regulations. Based on the present study, the following recommendations are made: the final decision on the TiO2 classification should be reconsidered together with those of other PSLT particles and take into account extensive developments in the field of nanoscience. Furthermore, the European Chemicals Agency (ECHA) should develop state-of-the-art guidance on how to use the available human exposure data. Finally, the authorities that are in charge of European Union chemicals management are advised to further develop the regulatory network to utilize the information generated in REACH processes as efficiently as possible and to verify that the connections between the regulations result in the intended outcome. Integr Environ Assess Manag 2019;00:1-12. © 2019 SETAC.

Compliance of e-cigarette refill liquids with regulations on labelling, packaging and technical design characteristics in nine European member states

ObjectiveTo evaluate electronic cigarette (e-cigarette) product compliance with European regulations (Tobacco Products Directive (TPD), Implementing Decisions), with a focus on labelling/packaging practices and technical design/safety features.MethodsBefore the implementation of the...

Technological performance of formaldehyde-free adhesive alternatives for particleboard industry

Due to their high reactivity, chemical versatility and economic competitiveness, formaldehyde-based poly-condensation adhesives are used in huge amounts - in 2010 in the order of 20 million metric tons - around the globe, primarily in the wood-processing industry. Since the 1970s formaldehyde emissions from products made thereof came under pressure and were reduced continuously. The discussion intensified again initiated by the latest European CLP (classification, labelling and packaging) regulation, which came into force in 2016, classifying formaldehyde as a Carcinogen Category 1B compound. In view of potential and even stronger future restrictions of formaldehyde use, appropriate alternatives to substitute formaldehyde-based adhesive systems such as urea formaldehyde would have to be developed and implemented in the wood processing industry. The present review represents a critical appraisal of formaldehyde-free adhesive systems for particulate wood composites production proposed in literature so far. Adhesive systems analyzed here include both synthetic and renewable-based adhesives. The core of the review is an assessment of the individual adhesive systems based on selected technological (product and process) parameters relevant for wood-particleboard production. Based on this data we evaluated their potential to identify suitable alternative adhesives having a certain probability to meet the requirements of a large-scale processing industry sector. As an overall conclusion, there are still many challenges to overcome to replace formaldehyde. Except for pMDI-based systems, most of the alternative adhesives are considerably less reactive, which would result in dramatically higher production costs. Furthermore, the availability of most components proposed to produce alternative adhesives are currently not available in the necessary quantities. Moreover, toxicological investigations on alternative systems are still missing. As several components replacing formaldehyde are also toxic or hazardous to different extents, it cannot be guaranteed that the individual proposed alternative adhesives are safer during processing and service life compared to conventional systems. Due to the nature of the organic material wood, particleboards will always release a certain amount of formaldehyde, even when produced with formaldehyde-free adhesives.

Consumer protection and risk assessment: sensitising substances in consumer products

The human immune system is confronted daily with a large, chemically-varied range of potentially sensitising substances. Skin sensitising substances are found, above all, in a plethora of consumer products, e. g. cosmetics, jewellery, earrings, toys, textiles, leather, other everyday commodities and, in some cases, also tattoos. These products may contain sensitisers such as fragrances, preservatives, dyes, or other additives. To provide a greater degree of consumer protection, there is a need for specific legal regulation and risk assessment, which covers each possible human exposure to a sensitising substance or mixture. This review article describes the background and pathway towards the development and implementation of an international legal framework for the classification and labelling of chemicals that contain potentially skin sensitising substances. This includes the implementation of the globally harmonized system of classification and labelling of chemicals (GHS), the classification, labelling and packaging (CLP) regulation, registration, evaluation, authorisation and restriction of chemicals (REACH), and the regulation of cosmetics, among other national laws and regulations. Assessment criteria for classification is derived from a suite of in vitro and in vivo assays, in addition to in silico approaches—validated by the organisation for economic cooperation and development (OECD)—as well as data derived from human studies. New legislation for chemical and product safety is reflected in the classification and labelling of skin sensitising substances under Category 1, Subcategory 1A or 1B, within which the threshold concentrations of several materials are regulated, e. g. p‑phenylenediamine in hair dyes, nickel in piercings, chromium VI in leather and methylisothizolinone in cosmetics. In order to minimise the risk of human contact allergy from consumer products, the scientific committee on consumer safety (SCCS) and the German federal institute for risk assessment (BfR) investigate pathways of exposure and perform risk assessments using new in vitro approaches and new (immuno-) toxicological concepts (i. e. adverse outcome pathways [AOPs], key events as well as an integrated approach to testing and assessment [IATA]). In comparison to cosmetics, substances in textiles and other consumer products are less regulated. Major efforts in research and development are necessary to decode complex substance-specific molecular mechanisms in allergic responses and to define new substance-specific thresholds. Such efforts have been continuously proposed by the BfR with regard to fragrances for over 10 years. Today, skin sensitising substances can be legally regulated and labelled and, depending on the exposure, their content in consumer products can be reduced or eliminated. Furthermore, the risk assessment of potentially sensitising substances makes consumer products safer. Further improvements in research approaches are required in the area of health and consumer protection with regard to allergy.

Does REACH provide sufficient information to regulate mutagenic and carcinogenic substances?

The REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) data requirements for mutagenicity and carcinogenicity have been compared to the criteria for classification under Classification, Labelling and Packaging (CLP) and the studies used as key evidence by Committee for Risk Assessment (RAC) in drafting its opinions on the appropriate classification. This comparison revealed that the REACH information requirements will not provide sufficient information to conclude a substance is a Cat 1B mutagen and/or carcinogen. In addition, requiring such information via a substance evaluation under REACH requires a large investment from the Member States and takes years. Classification and labeling is essential in the communication of the hazardous properties of substances and mixtures and is amongst others an important first step in the identification of a substance as a Substance of Very High Concern (SVHC). REACH will hardly generate sufficient information for classification of substances as category 1B for mutagenicity and carcinogenicity. Therefore, indications of very severe hazards of substances are missed and health risks could occur. There are various ways to deal with this problem, however as most of these require adaptation of regulations this will cost considerable time and political will. This study is a first step to raise awareness for the problem and to start a discussion to search for a sustainable solution.

Applicability of the fish embryo acute toxicity (FET) test (OECD 236) in the regulatory context of Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH).

In 2013 the Organisation for Economic Co-operation and Development (OECD) test guideline (236) for fish embryo acute toxicity (FET) was adopted. It determines the acute toxicity of chemicals to embryonic fish. Previous studies show a good correlation of FET with the standard acute fish toxicity (AFT) test; however, the potential of the FET test to predict AFT, which is required by the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation (EC 1907/2006) and the Classification, Labelling and Packaging (CLP) Regulation (EC 1272/2008), has not yet been fully clarified. In 2015 the European Chemicals Agency (ECHA) requested that a consultant perform a scientific analysis of the applicability of FET to predict AFT. The purpose was to compare the toxicity of substances to fish embryos and to adult fish, and to investigate whether certain factors (e.g., physicochemical properties, modes of action, or chemical structures) could be used to define the applicability boundaries of the FET test. Given the limited data availability, the analysis focused on organic substances. The present critical review summarizes the main findings and discusses regulatory application of the FET test under REACH. Given some limitations (e.g., neurotoxic mode of action) and/or remaining uncertainties (e.g., deviation of some narcotic substances), it has been found that the FET test alone is currently not sufficient to meet the essential information on AFT as required by the REACH regulation. However, the test may be used within weight-of-evidence approaches together with other independent, relevant, and reliable sources of information. The present review also discusses further research needs that may overcome the remaining uncertainties and help to increase acceptance of FET as a replacement for AFT in the future. For example, an increase in the availability of data generated according to OECD test guideline 236 may provide evidence of a higher predictive power of the test. Environ Toxicol Chem 2018;37:657-670. © 2017 SETAC.

Safe use of chemicals by professional users and health care specialists.

The awareness of Greek professional users and health care specialists regarding the safe use of chemicals was investigated, to be the best of our knowledge, for the first time after the introduction of Regulations (EC) 1907/2006 (REACH) and 1272/2008 (CLP) on chemicals. A total of 200 professional users and 150 health care specialists from various regions of Greece contributed to the use of a closed-ended, anonymous and validated questionnaire. The findings showed that over 85% of the responders were not aware of classification, labelling and packaging (CLP) and 67.8% of the responders were unaware of any changes made in the labeling of the products they were using. The majority (>75%) of individuals were cognizant that they were using hazardous products; however, the perception of hazard varied significantly between the two groups (P=0.012) and statistically were dependent on the educational (P=0.022) and the profession (P=0.014) level. One third of the professional users read the label as the main source of information for the product, while for health care specialists the number increased to 65% and a strong correlation was detected with the educational level (P=0.017). In both groups, 7% of professional users and health care specialists declared that hazard communication through product labeling is not well understood. The use of personal protective equipment (PPE) is almost universal for health care specialists with women being more sensitive (P=0.041), while 25% of the professional users do not use any PPE. Almost 60% of the health care specialists are required to provide instructions regarding the safe use of chemicals or the action to be undertaken in case of accident. In the latter situation, the National Poisoning Centre is the reference point for information. Limited use of the safety data sheets has been observed both for professional users (18%) and health care specialists (23%). In conclusion, rising awareness campaigns are needed, in collaboration with trade unions and health care professional associations, in order to alert professionals regarding the safe use of chemicals and protect human health and the environment.

The GARD platform for potency assessment of skin sensitizing chemicals.

Contact allergy induced by certain chemicals is a common health concern, and several alternative methods have been developed to fulfill the requirements of European legislation with regard to hazard assessment of potential skin sensitizers. However, validated methods, which provide information about the potency of skin sensitizers, are still lacking. The cell-based assay Genomic Allergen Rapid Detection (GARD), targeting key event 3, dendritic cell activation, of the skin sensitization AOP, uses gene expression profiling and a machine learning approach for the prediction of chemicals as sensitizers or non-sensitizers. Based on the GARD platform, we here expanded the assay to predict three sensitizer potency classes according to the European Classification, Labelling and Packaging (CLP) Regulation, targeting categories 1A (strong), 1B (weak) and no cat (non-sensitizer). Using a random forest approach and 70 training samples, a potential biomarker signature of 52 transcripts was identified. The resulting model could predict an independent test set consisting of 18 chemicals, six from each CLP category and all previously unseen to the model, with an overall accuracy of 78%. Importantly, the model was shown to be conservative and only underestimated the class label of one chemical. Furthermore, an association of defined chemical protein reactivity with distinct biological pathways illustrates that our transcriptional approach can reveal information contributing to the understanding of underlying mechanisms in sensitization.

Outcome of the consultation with Member States and EFSA on the basic substance application for Satureja montana L. for use in plant protection as fungicide and bactericide on various crops

EFSA Supporting PublicationsVolume 13, Issue 6 1051E Technical reportOpen Access Outcome of the consultation with Member States and EFSA on the basic substance application for Satureja montana L. for use in plant protection as fungicide and bactericide on various crops 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: 21 June 2016 https://doi.org/10.2903/sp.efsa.2016.EN-1051 Published date: 21 June 2016 Question number: EFSA-Q-2016-00217 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 References EFSA (European Food Safety Authority), 2012. Conclusion on the peer review of the pesticide risk assessment of the active substance thymol. EFSA Journal 2012; 10(11):2916, 43 pp. doi:10.2903/j.efsa.2012.2916. ECHA (European Chemicals Agency), 2015. Guidance on the Application of the CLP Criteria; Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures. Version 4.1, June 2015. Reference: ECHA-15-G-05-EN; ISBN: 978-92-9247-413-3; available online:http://echa.europa.eu/documents/10162/13562/clp_en.pdf ECHA (European Chemicals Agency), 2010. Guidance on information requirements and chemical safety assessment. Chapter R.16: Environmental exposure assessment, version 2.0, May 2010. ECHA (European Chemicals Agency), 2016. Guidance on information requirements and chemical safety assessment. Chapter R.16: Environmental exposure assessment, version 3.0, February 2016. Volume13, Issue6June 20161051E ReferencesRelatedInformation

Evaluation and comparison of benchmark QSAR models to predict a relevant REACH endpoint: The bioconcentration factor (BCF)

The bioconcentration factor (BCF) is an important bioaccumulation hazard assessment metric in many regulatory contexts. Its assessment is required by the REACH regulation (Registration, Evaluation, Authorization and Restriction of Chemicals) and by CLP (Classification, Labeling and Packaging). We challenged nine well-known and widely used BCF QSAR models against 851 compounds stored in an ad-hoc created database. The goodness of the regression analysis was assessed by considering the determination coefficient (R2) and the Root Mean Square Error (RMSE); Cooper's statistics and Matthew's Correlation Coefficient (MCC) were calculated for all the thresholds relevant for regulatory purposes (i.e. 100L/kg for Chemical Safety Assessment; 500L/kg for Classification and Labeling; 2000 and 5000L/kg for Persistent, Bioaccumulative and Toxic (PBT) and very Persistent, very Bioaccumulative (vPvB) assessment) to assess the classification, with particular attention to the models' ability to control the occurrence of false negatives. As a first step, statistical analysis was performed for the predictions of the entire dataset; R2>0.70 was obtained using CORAL, T.E.S.T. and EPISuite Arnot–Gobas models. As classifiers, ACD and logP-based equations were the best in terms of sensitivity, ranging from 0.75 to 0.94. External compound predictions were carried out for the models that had their own training sets. CORAL model returned the best performance (R2ext=0.59), followed by the EPISuite Meylan model (R2ext=0.58). The latter gave also the highest sensitivity on external compounds with values from 0.55 to 0.85, depending on the thresholds. Statistics were also compiled for compounds falling into the models Applicability Domain (AD), giving better performances. In this respect, VEGA CAESAR was the best model in terms of regression (R2=0.94) and classification (average sensitivity>0.80). This model also showed the best regression (R2=0.85) and sensitivity (average>0.70) for new compounds in the AD but not present in the training set. However, no single optimal model exists and, thus, it would be wise a case-by-case assessment. Yet, integrating the wealth of information from multiple models remains the winner approach.

Classification of reproductive toxicants with diverse mechanisms in the embryonic stem cell test.

The embryonic stem cell test (EST) is a promising system to detect embryotoxicity in vitro. Recent studies have pointed out some limitations of the EST and suggest that the applicability domain of the EST and its prediction model have to be better defined. Here, eight substances of known reproductive toxicity were tested in the EST under blind conditions. We applied the prediction model to the data of the EST after classifying the substances according to the published criteria. In addition, a simplified classification of the EST results into two classes as an approach to hazard assessment was compared to the European Union Classification, Labelling and Packaging (CLP) Regulation labels of the substances. With one exception, substances that are labeled as reproductive toxicants according to the CLP Regulation were detected as embryotoxic in the EST while substances without label were found to be non-embryotoxic according to the EST.

산업안전보건법상 관리대상 유해물질 선정기준 마련에 관한 연구

Objectives: This study was performed in order to establish reliable and relative selection criteria for hazardous substances requiring management(HSRM) in the Occupational Safety and Health Act in Korea. Methods: To determine the relative criteria and weight of evidence for HSRM, we analyzed the difference between the selection method of priority substances in studies by KOSHA(Korea Occupational Safety and Health Agency) and the European Union Risk Ranking Method(EURAM). In addition, 597 hazardous substances with exposure limit valueswereanalyzed and the posted health hazards classification by MOEL(Ministry of Employee and Labor), MOE(Ministry of Environment), and EU CLP(Classification, Labelling and Packaging regulation) were compared based on GHS(Globally Harmonized System of classification and labelling of chemicals) criteria. The existing HSRM(167 substances) were evaluated for suitability by the proposed criteria in this study. Results: As a result of this study, the criteria and procedures for selecting HSRM in the Occupational Safety and Health Act were arranged utilizing GHS health hazard classification results, occupational disease cases and domestic use situations. Conclusions: The applicability of the proposed criteria was proved via the evaluation of existing HSRM(167 substances). Most HSRM (161 substances) were found to correspond to a significant health effect or substantial health effect. The question of whether to include the six substances that have been found to have general health effects as HSRM would be require further research.

‘Read this and be safe!’ Comparison of regulatory processes for communicating risks of personal care products to European and South African consumers

Most personal care products (PCPs) contain hazardous ingredients, but current legislation in the European Union (EU) and South Africa (SA) does not require these to be labelled as hazardous products. Instead, ingredients must only be listed on containers to inform consumers of potential hazards. We assessed whether current legal strategies provide the means for effective risk communication (RC) mechanisms for PCPs in order to protect consumers’ health and the environment. RC strategies used in developed countries are not necessarily better compared to developing countries despite the existence of extensive legislation in the former. Socio-cultural factors, scientific literacy and language differences are key reasons why the current ingredient lists on PCP labels are not an effective RC strategy. The assumption is that consumers will interpret the risks of these ingredients by conducting a risk assessment for their personal context. Realistically, the following risk mitigation measures should be implemented in developed and developing countries to reduce the public’s potential exposures to hazardous substances: substitute hazardous ingredients with less hazardous; provide accessible mechanisms for consumers to comprehend RC measures; delete the exception clause in the EU Regulation on Classification, Labelling and Packaging (CLP); apply clear mandatory labels where PCPs health risks are clearly illustrated; and increase enforcement of legislation. The high incidence of fragrance allergies caused by PCPs is one example illustrating how current legal measures in the EU and SA fail to protect consumers and the environment from hazardous exposures. Therefore, efforts must be made to improve legally required RC measures.

Development and validation of a quantitative structure–activity relationship for chronic narcosis to fish

Vertebrate testing under the European Union's regulation on Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH) is discouraged, and the use of alternative nontesting approaches such as quantitative structure-activity relationships (QSARs) is encouraged. However, robust QSARs predicting chronic ecotoxicity of organic compounds to fish are not available. The Ecological Structure Activity Relationships (ECOSAR) Class Program is a computerized predictive system that estimates the acute and chronic toxicity of organic compounds for several chemical classes based on their log octanol-water partition coefficient (K(OW)). For those chemical classes for which chronic training data sets are lacking, acute to chronic ratios are used to predict chronic toxicity to aquatic organisms. Although ECOSAR reaches a high score against the Organisation for Economic Co-operation and Development (OECD) principles for QSAR validation, the chronic QSARs in ECOSAR are not fully compliant with OECD criteria in the framework of REACH or CLP (classification, labeling, and packaging) regulation. The objective of the present study was to develop a chronic ecotoxicity QSAR for fish for compounds acting via nonpolar and polar narcosis. These QSARs were built using a database of quality screened toxicity values, considering only chronic exposure durations and relevant end points. After statistical multivariate diagnostic analysis, literature-based, mechanistically relevant descriptors were selected to develop a multivariate regression model. Finally, these QSARs were tested for their acceptance for regulatory purposes and were found to be compliant with the OECD principles for the validation of a QSAR.