Setting surface wipe limits for skin sensitizers

Naumann, Bruce D.; Arnold, Susan

doi:10.1177/0748233719875365

Cited by 6 publications

(5 citation statements)

References 40 publications

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“…approach of calculating the surface wipe limits using LLNA-RI EC3 values was proposed (Naumann & Arnold, 2019). In their proposal, the Adjustment Factor was applied considering the distribution of the used for deriving the SAF interspecies in the present study may be considerably lower than the true NOELs, because the HRIPT is also often be performed at one dose set on the safer side as a dose that does not affect humans (Basketter & Safford, 2016), we decided that a value of AF interindividual of 10 is appropriate.…”

Section: Discussionmentioning

confidence: 99%

“…As described above, there is still some debate about the necessity of SAF for interspecies difference when using LLNA EC values as point of departures for HBELs instead of human data. With regard to skin sensitization QRA for occupational exposure control, the approach of calculating the surface wipe limits using LLNA‐RI EC3 values was proposed (Naumann & Arnold, 2019). In their proposal, the Adjustment Factor was applied considering the distribution of the LLNA‐RI EC3 values and HRIPT NOEL ratios (AF R ), to use LLNA‐RI EC3 values for estimation of the NOELs in humans.…”

Section: Discussionmentioning

confidence: 99%

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Acceptable surface limits (ASLs) of skin sensitizers derived from the local lymph node assay (LLNA): BrdU‐ELISA EC1.6 values and their relationships to known sensitization potency information

Fukushima

Hayashi

Takeyoshi

2022

J of Applied Toxicology

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Skin sensitization is an extremely important risk factor for occupational health and safety, and it would be desirable to set health‐based exposure limits (HBELs) for the quantitative risk assessment (QRA) based on the skin sensitizing potencies of chemical. We attempted to set acceptable surface limits (ASLs) as HBELs for skin sensitizers in the workplace based on the local lymph node assay (LLNA): BrdU‐ELISA EC1.6 values. To calculate the ASLs, a safety assessment factor (SAF)interspecies value of 6, based on the EC1.6 values/human repeat insult patch test (HRIPT) NOEL ratios, a SAFinterindividual value of 10, and a SAFfrequency/duration value of 3 were applied, referring to previous literatures on SAFs for skin sensitization QRA, and the composite SAF was calculated as 180. The ASLs (mg/100 cm2) derived thus for 33 chemicals ranged from 0.001 to 10.417. Comparison of the ranges with known human sensitization potency classes and GHS subcategories revealed that use of GHS Category 1A chemicals needs to be controlled to ensure surface residue levels of less than 1 mg/100 cm2. To minimize sensitization risks, a quantitative sensitization risk assessment method for chemicals and appropriate risk management are necessary. This report provides a potentially useful ASL‐based method of managing sensitization risk derived from LLNA: BrdU‐ELISA EC1.6 values, comparison of the ASLs and known human sensitization potency data showed that GHS subcategorization results would be a primary information notifying ASL ranges to be required for minimizing the sensitization risk.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Acceptable surface limits (ASLs) of skin sensitizers derived from the local lymph node assay (LLNA): BrdU‐ELISA EC1.6 values and their relationships to known sensitization potency information

Fukushima

Hayashi

Takeyoshi

2022

J of Applied Toxicology

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“…Occupational hygienists rely on occupational exposure limits to assess hazardous levels of exposure to physical, chemical, and biological agents in the workplace and to verify that exposure control measures are adequate to prevent adverse health effects. In 2019, the American Conference of Governmental Industrial Hygienists (ACGIH) adopted a Threshold Limit Value–Surface Limit (TLV–SL) for OPA of 25 μg/100 cm 2 ( Naumann and Arnold 2019 ). The basis for the TLV–SL for OPA was to prevent the induction of dermal and respiratory sensitization following dermal exposure.…”

Section: Introductionmentioning

confidence: 99%

“…TLV–SL are intended to supplement airborne TLVs to provide quantitative criteria for skin exposure, an important secondary route of exposure, at an acceptable surface concentration. Naumann and Arnold (2019) illustrate how the surface limit was derived using the murine local lymph node assay (LLNA) and effective concentration (EC3) value for OPA, with an adjustment factor applied for being a potent sensitizer. OPA has also been assigned a TLV–Ceiling airborne concentration of 0.1 ppb, measured as vapour fraction, to reduce the risk of developing skin, respiratory, and eye symptoms as well as sensitization.…”

Section: Introductionmentioning

confidence: 99%

An approach to quantify ortho-phthalaldehyde contamination on work surfaces

Rogers

Gaskin

Thredgold

et al. 2023

Annals of Work Exposures and Health

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Ortho-phthalaldehyde (OPA) is used as a high-level disinfectant for reusable medical devices in healthcare settings. The ACGIH recently adopted a Threshold Limit Value–Surface Limit (TLV–SL; 25 µg/100 cm2) for OPA surface contamination to prevent induction of dermal and respiratory sensitization following dermal exposure. However, there is no current validated method to measure OPA surface contamination. This study aimed to develop a standardized approach for sample collection and quantitative determination of OPA from work surfaces for use in risk assessment practices. The reported method utilises readily available commercial wipes to collect surface samples coupled with direct detection of OPA via liquid chromatography time of flight mass spectrometry (LC–ToF–MS). This approach avoided complex derivatization steps commonly required for the analysis of aldehydes. Method evaluation was conducted in accordance with the Occupational Safety and Health Administration (OSHA) surface sampling guidelines. Overall recoveries of 25 µg/100 cm2 of OPA from stainless steel and glass surfaces were 70% and 72%, respectively. The reported LOD for this method was 1.1 µg/sample and the LOQ was 3.7 µg/sample. OPA remained stable on the sampling medium for up to 10 days, when stored at 4 °C. The method was demonstrated in a workplace surface assessment at a local hospital sterilising unit, successfully detecting OPA on work surfaces. This method is intended to supplement airborne exposure assessment and provide a quantitative assessment tool for potential dermal exposure. When used in conjunction with a thorough occupational hygiene program that includes hazard communication, engineering controls, and personal protective equipment, skin exposure and consequent sensitization risks in the workplace can be minimized.

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“…Additionally, it can be used not only for hazard identification but also prediction of potency . The latter is important for occupational safety since relative potency can aid in the selection of a peptide coupler and the determination of appropriate occupational exposure controls, including containment technology, personal protective equipment (PPE), and the development and application of safe residual surface wipe limits. − As much as in silico modeling provided impetus for animal testing, LLNA results were subsequently used to inform changes in computational models. This interactive approach resulted in a horizontally integrated in vivo - in silico framework, which can be applied to reliably assess the dermal-sensitization hazard of novel peptide couplers.…”

Section: Introductionmentioning

confidence: 99%

An Evaluation of the Occupational Health Hazards of Peptide Couplers

Graham¹,

Trejo‐Martin

Chilton

et al. 2022

Chem. Res. Toxicol.

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Peptide couplers (also known as amide bond-forming reagents or coupling reagents) are broadly used in organic chemical syntheses, especially in the pharmaceutical industry. Yet, occupational health hazards associated with this chemical class are largely unexplored, which is disconcerting given the intrinsic reactivity of these compounds. Several case studies involving occupational exposures reported adverse respiratory and dermal health effects, providing initial evidence of chemical sensitization. To address the paucity of toxicological data, a pharmaceutical cross-industry task force was formed to evaluate and assess the potential of these compounds to cause eye and dermal irritation as well as corrosivity and dermal sensitization. The goal of our work was to inform health and safety professionals as well as pharmaceutical and organic chemists of the occupational health hazards associated with this chemical class. To that end, 25 of the most commonly used peptide couplers and five hydrolysis products were selected for in vivo, in vitro , and in silico testing. Our findings confirmed that dermal sensitization is a concern for this chemical class with 21/25 peptide couplers testing positive for dermal sensitization and 15 of these being strong/extreme sensitizers. We also found that dermal corrosion and irritation (8/25) as well as eye irritation (9/25) were health hazards associated with peptide couplers and their hydrolysis products (4/5 were dermal irritants or corrosive and 4/5 were eye irritants). Resulting outcomes were synthesized to inform decision making in peptide coupler selection and enable data-driven hazard communication to workers. The latter includes harmonized hazard classifications, appropriate handling recommendations, and accurate safety data sheets, which support the industrial hygiene hierarchy of control strategies and risk assessment. Our study demonstrates the merits of an integrated, in vivo - in silico analysis, applied here to the skin sensitization endpoint using the Computer-Aided Discovery and REdesign (CADRE) and Derek Nexus programs. We show that experimental data can improve predictive models by filling existing data gaps while, concurrently, providing computational insights into key initiating events and elucidating the chemical structural features contributing to adverse health effects. This interactive, interdisciplinary approach is consistent with Green Chemistry principles that seek to improve the selection and design of less hazardous reagents in industrial processes and applications.

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Setting surface wipe limits for skin sensitizers

Cited by 6 publications

References 40 publications

Acceptable surface limits (ASLs) of skin sensitizers derived from the local lymph node assay (LLNA): BrdU‐ELISA EC1.6 values and their relationships to known sensitization potency information

Acceptable surface limits (ASLs) of skin sensitizers derived from the local lymph node assay (LLNA): BrdU‐ELISA EC1.6 values and their relationships to known sensitization potency information

An approach to quantify ortho-phthalaldehyde contamination on work surfaces

An Evaluation of the Occupational Health Hazards of Peptide Couplers

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