Eye Hazards Research Articles

The EU Detergent Industry Network ‘DetNet’ – an industry approach for the EU CLP classification of detergent and cleaning products for skin and eye effects

Abstract The implementation of the EU CLP Regulation for mixtures in 2015 led to a reduction of the cut-off levels for mixtures containing severely irritating or corrosive ingredients. As a result, most everyday detergents would be required to carry the same corrosive pictogram on the label as caustic or highly acidic specialty cleaners. However, in most cases, calculation-derived skin and eye hazard classifications do not reflect in-market experience and consumer understanding of the hazardous properties of household detergents. The detergent industry responded to this situation by forming the Detergent Industry Network ‘DetNet’. It is a transparent process that supports mixture classification decisions by sharing data, expertise, and best practices between manufacturers of detergent and cleaning products. At the core of DetNet is its database providing access to compositional information and toxicological data on more than 240 detergents and cleaning products. This paper describes and discusses the main features of DetNet, its organisational structure and database. Based on a case study, the process and functioning of DetNet to support a scientifically sound classification of an untested mixture for skin and eye effects based on data available for similar mixtures is demonstrated.

Development of an Eye Irritation Test Method Using an In-House Fabrication of a Reconstructed Human Cornea-like Epithelium Model for Eye Hazard Identification.

In a previous study, a novel human corneal-like epithelium model utilizing an immortalized human corneal epithelial cell line (iHCE-NY1) was developed as an alternative to animal models to identify chemicals not classified under the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS) and was evaluated following the criteria of Test Guideline 492 of the Organization for Economic Co-operation and Development (OECD). In the present study, our aim was to establish an eye irritation test protocol using the iHCE-NY1 model to classify liquid chemicals under the GHS ocular hazard categories: no effect, no classification (No Cat.), Category 2 (Cat. 2) reversible effects, and Category 1 (Cat. 1) irreversible eye damage. The protocol involved exposing the iHCE-NY1 model to 31 liquid test chemicals for 5 min, followed by observation at post-incubation periods (PIPs) to assess recovery. Classification was based on cell viability, and histopathological findings on PIP days 7, 14, and 21. The outcomes were compared with an established database of classifications. All Cat. 1 liquid chemicals, 62.5% of No Cat., and 63.2% of Cat. 2 were correctly categorized. This study demonstrates that the iHCE-NY1 model can not only distinguish No Cat. test liquid chemicals but also differentiate between Cat. 2 and Cat. 1 liquid chemicals.

Development of a proposed Laser Safety Protocol (LSP) for the prevention of eye and skin hazards in Biomedical Laser facilities

Usage of LASER radiation applications is very widespread in numerous specific areas of Biomedical Sciences with proven clinical and treatment results. Furthermore, the apparatus used in Biomedical applications are classified in highest power and danger categories (class 3B or 4). Thus, establishing and keeping necessary laser safety measures is crucial for the assurance of health, safety, ergonomics conditions and specially for the prevention of eye and skin hazards, both for biomedical scientists and patients in health and care units of any scale. To our knowledge, the existing protocols in relevant literature, are quite limited and depict only the basic Laser Safety guidelines. The subject of this study is the development of a complete and detailed Laser Safety Protocol to be implemented in all biomedical facilities. The novelty of the proposed LSP is that it is formulated both in extended verbal instructions and, principally, in a “matrix form”, well defined procedure.

Performance of the DASF compared to other combinations of OECD NAMs for eye hazard identification of surfactants.

Currently, the OECD has adopted three defined approaches (DAs) for eye hazard identification of non-surfactant liquids and solids (TG467) according to the three UN GHS categories (Cat.1, Cat.2, No Cat.). We are now expanding the applicability domain with a new DA for chemicals having surfactant (SF) properties (DASF). It is based on a combination of RhCE test methods (OECD TG492: EpiOcular™ EIT or SkinEthic™ HCE EIT) and a modification of the Short Time Exposure (STE, TG491) method. The aim of the current study was to compare the performance of the DASF with the performance of other NAMs currently included in the OECD TGs and with the classification based on the Draize eye test to identify potential additional DAs. The minimum performance criteria (75% Cat.1, 50% Cat.2, 70% No Cat.) used for the adoption of the DAs currently included in OECD TG467 were used for this purpose. The DASF identified 90.9% of Cat. 1 (N=23), 77.8% of Cat. 2 (N=9) and 76.0% of No Cat. (N=17) surfactants, meeting the minimum performance criteria. Some of the NAMs that are currently included in the OECD TGs seem promising methods to be part of a DA to identify Cat. 1 or No Cat. for eye hazard assessment of surfactants. However, the number of surfactants that have been tested to evaluate reliability and relevance was often too small. To date, the DASF is the only DA that has evaluated a sufficiently large number of surfactants and whose performance met the OECD acceptance criteria.

Development of a defined approach for eye hazard identification of solid chemicals according to the three UN GHS categories.

Currently there are two OECD-adopted defined approaches (DA) for eye hazard identification of non-surfactant liquids (OECD TG 467). The current study aimed to develop a DA for eye hazard identification of solid chemicals according to the three UN GHS categories (Cat.1, Cat. 2, No Cat.): the DAS. The DAS combines two test methods described in OECD TG 437 and TG 492. The DAS was developed based on in-depth statistical analysis of a database on solids containing in vitro and historically curated in vivo Draize eye test data. The performance of the DAS was assessed by comparing the predictions with the classification based on in vivo Draize eye test data, on the one hand, and with the performance criteria established by the OECD expert group, on the other hand. In a first tier of the DAS, the SkinEthic™ HCE EIT method (TG 492) is used to distinguish No Cat. from classified substances. For classified substances, the BCOP LLBO method (TG 437) is used to identify Cat. 1, and the remaining solids are predicted Cat. 2. In summary, 77.4% Cat. 1 (N=31), 52.3% Cat. 2 (N=18), and 70.0% of No Cat. (N=60) solids were correctly identified compared to the classification based on the Draize eye test. The percentage of correct predictions met the minimum OECD performance values of 75% Cat. 1, 50% Cat. 2, and 70% No Cat., and the percentage of mispredictions was below the established maximum values. Therefore, inclusion of the DAS in OECD TG 467 has been achieved.

Performance of the DASF compared to other combinations of OECD NAMs for eye hazard identification of surfactants_suppl

Performance of the DASF compared to other combinations of OECD NAMs for eye hazard identification of surfactants_suppl

Behaviour change interventions to facilitate forest trail users’ biosecurity compliance

Natural resource management can struggle with increased visitation that inadvertently deteriorates the environment. In Aotearoa New Zealand, visitors to kauri forests are spreading a lethal soil pathogen resulting in cultural and conservation risk. While public awareness of kauri dieback disease is growing, compliance at hygiene stations has not similarly increased. To overcome this apparent knowledge-behaviour gap, five interventions (ambassadors, normative messaging, watching eye effect, hazard perception, and pledge board) were evaluated for their impact on visitor compliance with footwear/equipment cleaning behaviour. Behavioural observations (n = 10,536) and intercept surveys (n = 3,061) were collected. Ambassadors resulted in increased compliance for both visitors and local trail users. The pledge board resulted in increased compliance for local trail users only and normative message increased compliance at one visitor site. Hazard perception and watching eye resulted in a decrease in compliance behaviour. This research demonstrates the need for careful assessment of interventions designed to mitigate the impacts of visitors to conservation areas. The success of the ambassador intervention, the pledge board for locals and, to a lesser extent, the normative message at one location, offer field-based empirical evidence supporting the use of social norms in communication approaches aimed at influencing visitor behaviour in natural resource settings.

Preliminary Study on an Alternative Test Method with MCTT HCETM for Ocular Irritation Test of Ophthalmic Medical Devices

The sustained growth of the market for ophthalmic medical devices has increased the demand for alternatives to animal testing for the evaluation of eye irritation. The International Organization for Standardization has acknowledged the need to develop novel in vitro tests to replace animal testing. Here, we evaluated the applicability of an alternative method based on a human corneal model to test the safety of ophthalmic medical devices. 2-Hydroxyethyl methacrylate (HEMA) and Polymethyl methacrylate (PMMA), which are used to fabricate contact lenses, were used as base materials. These materials were blended with eye irritant and non-irritant chemicals specified in the OECD Test Guideline (TG) 492 and Globally Harmonized System (GHS) classification. Then, three GLP-certified laboratories performed three replicates using the developed method using 3D reconstructed human cornea epithelium, MCTT HCETM. OECD TG 492 describes the procedure used to evaluate the eye hazard potential of the test chemical based on its ability to induce cytotoxicity in a reconstructed human cornea-like epithelium (RhCE) tissue. Results: The within-laboratory reproducibility (WLR) and between-laboratory reproducibility (BLR) were both 100%. When a polar extraction solvent was used, the sensitivity, specificity, and accuracy were all 100% in each laboratory. When a non-polar extraction solvent was used, the sensitivity was 80%, the specificity was 100%, and the accuracy was 90%. The proposed method exhibited excellent reproducibility and predictive capacity within and between laboratories. Therefore, the proposed method using the MCTT HCETM model could be used to evaluate eye irritation caused by ophthalmic medical devices.

Development of a Defined Approach for Eye hazard identification of chemicals having surfactant properties according to the three UN GHS categories

The purpose of this study was to develop a defined approach (DA) for eye hazard identification according to the three UN GHS categories for surfactants (DASF). The DASF is based on a combination of Reconstructed human Cornea-like Epithelium test methods (OECD TG 492; EpiOcular™ EIT and SkinEthic™ HCE EIT) and the modified Short Time Exposure (STE) test method (0.5% concentration of the test substance after a 5-min exposure).DASF performance was assessed by comparing the prediction results with the historical in vivo data classification and against the criteria established by the OECD expert group on eye/skin.The DASF yielded a balanced accuracy of 80.5% and 90.9% of Cat. 1 (N = 22), 75.0% of Cat. 2 (N = 8), and 75.5% of No Cat. (N = 17) surfactants were correctly predicted. The percentage of mispredictions was below the established maximum values except for in vivo No Cat. surfactants that were over-predicted as Cat. 1 (5.6%, N = 17), with a maximum value set at 5%. The percentage of correct predictions did meet the minimum performance values of 75% Cat. 1, 50% Cat. 2, and 70% No Cat. established by the OECD experts. The DASF has shown to be successful for eye hazard identification of surfactants.

P17-23 Innovative defined approaches for non-surfactant liquids for eye hazard assessment based on physicochemical properties and OECD-approved test methods

P17-23 Innovative defined approaches for non-surfactant liquids for eye hazard assessment based on physicochemical properties and OECD-approved test methods

P17-18 Performance of a new defined approach for surfactants for eye hazard assessment based on in vitro test methods

P17-18 Performance of a new defined approach for surfactants for eye hazard assessment based on in vitro test methods

SOC-VI-09 SkinEthic™ HCE Time-to-Toxicity: on the way of being the first OECD adopted new approach methodology allowing the identification on its own of substances and mixtures for eye hazard identification

SOC-VI-09 SkinEthic™ HCE Time-to-Toxicity: on the way of being the first OECD adopted new approach methodology allowing the identification on its own of substances and mixtures for eye hazard identification

Application of Virtual Reality (VR) Technology in the Assessment of Eye Hazards Caused by Laser Radiation And Selection of Individual Eye Protection Equipment

This paper discusses the issues of eye protection against harmful laser radiation and provides an example of the use of virtual reality (VR) technology for laser safety training. A newly developed VR application dedicated to the selection of protective eyewear in the context of identified real-life threats caused by harmful high-energy optical radiation is presented. The VR application for selecting protective eyewear to operate different types of lasers presented in this paper demonstrates how VR technology can be used to better illustrate the issues involved in assessing eye risks from laser radiation. The application was developed in the Unity 3D environment based on a scenario developed by the authors.

In-house performance assessment of 3D QobuR-Reconstructed Human Cornea-Like Epithelium (RhCE) for the evaluation of eye hazard

To replace the Draize eye irritation test (OECD Test Guideline 404), several test methods based on reconstructed cornea-like epithelium (RhCE) have been developed and adopted in the OECD TG 492. The objective of this study was to stablish the experimental procedures and evaluate the performance assessment of QobuR-RhCE, an in-house RhCE model to be used for the evaluation of eye hazard. We define the essential structural, functional and procedural elements of the test method components to help assuring that the proposed test method is based on the same concepts as the validated reference methods. Performance assessment was evaluated in accordance with the revised performance standards for the assessment of proposed similar or modified in vitro reconstructed human cornea-like epithelium and the minimum list of reference chemicals was evaluated. As result, the proposed method scored 93.3% sensibility, 60% specificity, 76.7% accuracy and 96.7% within-laboratory reproducibility (WLR), providing a similar performance in comparison to the validated reference methods. Additionally, we describe a secondary endpoint based on Transepithelial Electrical Resistance (TEER) that could be of use to better discriminate between irritants and non-irritants. Taken together the results indicate that the QobuR-RhCE test method is an accurate screening tool that can be used as a standalone alternative to evaluate ocular irritation.

Laser dazzler emitting three-colour radiation

The article presents a laser dazzle generating three overlapping laser beams of different colours and an analysis of the possibility of dazzling people with this radiation. The analysis took into account the eye’s photopic sensitivity and the additivity of the three radiation beams. Such analysis, to the knowledge of the authors, is presented for the first time. The possibility of dazzling for four different dazzle levels and three levels of ambient luminance was presented. It has been shown that in some conditions it is possible to damage the eye without causing the assumed dazzle effect. Full Text: PDF ReferencesJoint Non-Lethal Weapons Program, Non-Lethal Optical Distracters Fact Sheet, (2016). DirectLink https://www.faa.gov/about/initiatives/lasers/laws/ DirectLink N. Raoof, et al., "‘Toy’ laser macular burns in children", Eye 28, 231 (2014). CrossRef D. B. Gosling, J. B. O'Hagan, and F. M. Quhill, "Blue Laser Induced Retinal Injury in a Commercial Pilot at 1300 ft", Aerospace Medicine and Human Performance 87, 69 (2016). CrossRef J. Marshall, J. B. O'Hagan, and J. R. Tyrer, "Eye hazards of laser ‘pointers’ in perspective", Br. J. Ophthalmol. 100, 583 (2016). CrossRef N. Raoof, J. O'Hagan, N. Pawlowska, and F. Quhill, "Toy’ laser macular burns in children: 12-month update", Eye 30, 492 (2016). CrossRef S. Androudi and E. Papageorgiou, "Macular Hole from a Laser Pointer", New England Journal of Medicine 378, 2420 (2018) CrossRef J. E. Neffendorf, G. D. Hildebrand and S. M. Downes, "Handheld laser devices and laser-induced retinopathy (LIR) in children: an overview of the literature", Eye 33, 1203 (2019). CrossRef E. Linton, et al., "Retinal burns from laser pointers: a risk in children with behavioural problems", Eye 33, 492 (2019). CrossRef P. Dockrill, Science alert, (2020). DirectLink IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements (International Electrotechnical Commission 2014). DirectLink ANSI Z136.1-2014, American National Standard for Safe Use of Lasers (American National Standards Institute 2014). DirectLink C. A. Williamson and L. N. McLin, "Nominal ocular dazzle distance (NODD)", Appl. Opt. 54, 1564 (2015). CrossRef C. A. Williamson and L. N. McLin, "Determination of a laser eye dazzle safety framework", Journal of Laser Applications 30, 032010 (2018). CrossRef J. Mlynczak, K. Kopczynski, M. Kaliszewski, M. Wlodarski, "Estimation of nominal ocular hazard distance and nominal ocular dazzle distance for multibeam laser radiation", Applied Optics, 60(22), 6414-6421 (2021). CrossRef CVRL Database, CVRL functions, Luminous efficiency functions, 2-deg functions. DirectLink Peter Lennie, Joel Pokorny, and Vivianne C. Smith, "Luminance", Journal of the Optical Society of America A, 10 (6), 1283-1293, (1993) CrossRef H. Cai and T. Chung, "Evaluating discomfort glare from non-uniform electric light sources", Lighting Research & Technology, 45 (3), 267-294 (2012). CrossRef

Validation of the SkinEthic HCE Time-to-Toxicity test method for eye hazard classification of chemicals according to UN GHS

This study describes the within- and between-laboratory reproducibility (WLR and BLR) of a Time-to-Toxicity (TTT) approach for chemicals based on the SkinEthic™ HCE tissue construct, capable to distinguish chemicals that do not require classification for serious eye damage/eye irritation (No Cat.) from chemicals that require classification for eye irritation (Cat. 2), and serious eye damage (Cat. 1). The WLR and BLR was assessed with three participating laboratories. Each laboratory tested 40 coded chemicals in three independent runs. The predictive capacity of the method was assessed on a larger set of 150 chemicals (70 liquids and 80 solids) by combining the results of this study with the results of the test method developer.The WLR for the 20 liquids ranged from 85% to 95% with a BLR of 90%. For the 20 solids, a WLR and BLR of 100% was obtained. The test method developer obtained a WLR of 80% and 95%, based on 50 liquids and 48 solids tested in three independent runs, respectively. Regarding the predictive capacity, the SkinEthic™ HCE TTT test method identified 80.8% Cat. 1, 69.2% Cat. 2, and 74.9% No Cat. correctly. An independent peer review panel concluded that based on all available data, the relevance and reliability of the SkinEthic™ HCE TTT has been demonstrated for discriminating the three UN GHS eye hazard categories.

Occupational electromagnetic spectrum hazards and the significance of artificial optical radiation: country report for Greece.

Background:The electromagnetic spectrum spans over an enormous range from 0 up to more than 1020 Hz in the deep ionizing region, significant exposures exist in specific occupational environments. Between the ionizing and the electromagnetic fields (EMF) part of the spectrum, the ‘optical radiation’ (OR) region has specific properties. Comparative and concise evaluation enables action prioritization.Methods:Following the transposition and implementation periods of the artificial optical radiation (AOR) and EMF European Directives, the Hellenic Ministry of Labour in collaboration with the Greek Atomic Energy Commission (EEAE) and the National Technical University of Athens, conducted thorough occupational exposure investigation in Greece. Using dedicated measuring equipment and procedures, the majority of EMF emitting installations in Greece and also AOR emitting installations including arc welding, lasers and PC monitors has been assessed.Results:Measurement results from occupational settings reveal that it is the non-coherent metal arc welding AOR that can pose even sub-second overexposures. Rare EMF overexposures are manageable and EMF concern is not justified. Maintenance procedures demand proper attention. Preliminary laser safety assessment reveals OHS gaps and potential eye and skin hazards. Blue light exposure from computer monitors is well below safety limits.Conclusions:This electromagnetic spectrum risk assessment conducted in Greece enables the justification of the real occupational hazards, in this sense: i) EMF exposure assessment has to be concentrated to maintenance procedures; ii) AOR measuring setups are challenging and standardized measurement procedures are missing, and iii) AOR overexposures from arc welding pose significant eye and skin hazards.

Performance Statistics of Defined Approaches for Eye Hazard Identification of Non-Surfactant Liquids to Distinguish Between the Three United Nations Globally Harmonized System Categories

Introduction: Cosmetics Europe develops two defined approaches (DAs) for eye hazard identification, that is, addressing serious eye damage (Cat. 1), eye irritation (Cat. 2), and the absence thereof (No Cat.), for nonsurfactant liquid test substances. DAL-1 combines four physicochemical properties, the reconstructed human cornea-like epithelium (EpiOcular™ eye irritation test [EIT]: VRM1 and SkinEthic™ human corneal epithelium EIT: VRM2) test method (OECD test guideline [TG] 492), and bovine corneal opacity and permeability (BCOP) test method (OECD TG 437). DAL-2 combines the short time exposure test method (OECD TG 491) and the BCOP test method (OECD TG 437). In both DAs, the BCOP with the laser light-based opacitometer is used, however, only opacity is used to identify liquids that cause serious eye damage. Materials and Methods: The performance of the DAs to distinguish between the three United Nations Globally Harmonized System of Classification (UN GHS) categories was compared against the minimum performance values proposed by Cosmetics Europe to the Organisation for Economic Co-operation and Development expert Group on eye/skin irritation/corrosion and phototoxicity and agreed upon by the experts. Furthermore, the class-specific performance metrics are also provided for each DA. Results: The balanced accuracy of DAL-1 with validated reference method—EpiOcular EIT (VRM1), DAL-1 with validated reference method—SkinEthic HCE EIT (VRM2), and DAL-2 was 69.2%, 75.2%, and 74.3%, respectively. DAL-1 with VRM1 identified 76.5% of Cat. 1 (N = 17), 59.1% of Cat. 2 (N = 22), and 72.1% of No Cat. (N = 55) correctly. DAL-1 with VRM2 identified 76.5% of Cat. 1 (N = 17), 68.7% of Cat. 2 (N = 23), and 80.4% of No Cat. (N = 46) correctly. DAL-2 identified 81.2% of Cat. 1 (N = 17), 56.3% of Cat. 2 (N = 24), and 85.3% of No Cat. (N = 123) correctly. Conclusion: The percentage of correct predictions was greater than the proposed minimum performance values of 75% for Cat. 1, 50% for Cat. 2, and 70% for No Cat. Therefore, DAL-1 and DAL-2 have shown to successfully distinguish between the three UN GHS categories for eye hazard identification.

Performance statistics of defined approaches for eye hazard identification of liquids to distinguish between the three UN GHS categories

Performance statistics of defined approaches for eye hazard identification of liquids to distinguish between the three UN GHS categories

Defined approaches to differentiate between the three UN GHS categories for eye hazard identification -overall and class-specific performance metrics

Defined approaches to differentiate between the three UN GHS categories for eye hazard identification -overall and class-specific performance metrics