Classes of organic pigments meet tentative PSLT criteria and lack toxicity in short-term inhalation studies

Stratmann, Heidi; Wohlleben, Wendel; Wiemann, Martin; Vennemann, Antje; End, Nicole; Veith, Ulrich; Ma‐Hock, Lan; Landsiedel, Robert

doi:10.1016/j.yrtph.2021.104988

Cited by 7 publications

(3 citation statements)

References 30 publications

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“…One notes that the analysis of abiotic reactivity, abiotic pulmonary dissolution, in vitro reactivity and in vivo inhalation also suggested the non-grouping of metal-laked pigments. 49,50…”

Section: Resultsmentioning

confidence: 99%

“…A total of 6 commercialized organic pigments, sorted into 3 chemical classes (ML2A, Isoindolinone and DPP), were obtained from BASF SE, and were described elsewhere. 49,50 These materials were used within the scope of the H2020 project "GRACIOUS: Grouping, Read-Across, CharacterIsation and classicatiOn framework for regUlatory risk assessment of manufactured nanomaterials and Safer design of nanoenabled products".…”

Section: Methodsmentioning

confidence: 99%

“…One notes that the analysis of abiotic reactivity, abiotic pulmonary dissolution, in vitro reactivity and in vivo inhalation also suggested the non-grouping of metallaked pigments. 49,50 2.4.2 Towards grouping: similarity of dissolution behavior exemplied by the assessment of Type 3 DIN and Type 1 NR data, each analyzed by two different similarity algorithms. For the purpose of grouping NFs with respect to toxicity following oral exposure, the acquisition of comparative data on OGI dissolution is required.…”

Section: Screening Of Dissolution Kinetics and Transformation By Usin...mentioning

confidence: 99%

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Critical aspects in dissolution testing of nanomaterials in the oro-gastrointestinal tract: the relevance of juice composition for hazard identification and grouping

Di Cristo,

Keller,

Leoncino

et al. 2024

Nanoscale Adv.

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“…One notes that the analysis of abiotic reactivity, abiotic pulmonary dissolution, in vitro reactivity and in vivo inhalation also suggested the non-grouping of metal-laked pigments. 49,50…”

Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Screening Of Dissolution Kinetics and Transformation By Usin...mentioning

confidence: 99%

See 1 more Smart Citation

Critical aspects in dissolution testing of nanomaterials in the oro-gastrointestinal tract: the relevance of juice composition for hazard identification and grouping

Di Cristo,

Keller,

Leoncino

et al. 2024

Nanoscale Adv.

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Lehren aus dem Gruppieren von Chemikalien zur Bewertung der Risiken für die Gesundheit des Menschen

Wohlleben

Mehling²,

Landsiedel

2023

Angewandte Chemie

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Analog zum Periodensystem, das Elemente nach ihrer Ähnlichkeit der Strukturen und chemischen Eigenschaften gruppiert, kann die Gefahr chemischer Stoffe in Gruppen mit ähnlichen Strukturen und ähnlichen toxikologischen Eigenschaften bewertet werden. Im Folgenden werden Fallbeispiele zu Gruppierungsstrategien vorgestellt, welche die Bewertungen von Gefahr, Exposition und Risiko für die menschliche Gesundheit unterstützen. Sowohl unter EU-REACh als auch im US-TSCA New Chemicals Programm ist in der Regel die strukturelle Ähnlichkeit die Grundlage für eine Gruppierungt. Allerdings ist dieses Kriterium nicht immer angemessen und ausreichend. Auf der Grundlage der gewonnenen Erkenntnisse leiten wir zehn Grundsätze für die Gruppierung ab, darunter: die transparente Darstellung des Zwecks der Gruppierung, die Definition der Kriterien für eine Gruppierung und die Grenzen der Gruppen, eine dieEinbeziehung oder der Ausschluss eines Stoffs in oder aus einer Gruppe aufgrund toxikologischer Eigenschaften und eine Begründung der Zuordnung durch robuste Daten aus angemessenen Methoden. Diese Grundsätze gelten sowohl für eine erste Gruppierung zur Priorisierung weiterer Maßnahmen als auch für die endgültige Gruppierung zur Gewinnung von Daten für die Risikobewertung. Beides kann ein effektives Risikomanagement forcieren.

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Lessons Learned from the Grouping of Chemicals to Assess Risks to Human Health

Wohlleben

Mehling²,

Landsiedel

2023

Angew Chem Int Ed

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In analogy to the periodic system that groups elements by their similarity in structure and chemical properties, the hazard of chemicals can be assessed in groups having similar structures and similar toxicological properties. Here we review case studies of chemical grouping strategies that supported the assessment of hazard, exposure, and risk to human health. By the EU-REACH and the US-TSCA New Chemicals Program, structural similarity is commonly used as the basis for grouping, but that criterion is not always adequate and sufficient. Based on the lessons learned, we derive ten principles for grouping, including: transparency of the purpose, criteria, and boundaries of the group; adequacy of methods used to justify the group; and inclusion or exclusion of substances in the group by toxicological properties. These principles apply to initial grouping to prioritize further actions as well as to definitive grouping to generate data for risk assessment. Both can expedite effective risk management.

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Classes of organic pigments meet tentative PSLT criteria and lack toxicity in short-term inhalation studies

Cited by 7 publications

References 30 publications

Critical aspects in dissolution testing of nanomaterials in the oro-gastrointestinal tract: the relevance of juice composition for hazard identification and grouping

Critical aspects in dissolution testing of nanomaterials in the oro-gastrointestinal tract: the relevance of juice composition for hazard identification and grouping

Lehren aus dem Gruppieren von Chemikalien zur Bewertung der Risiken für die Gesundheit des Menschen

Lessons Learned from the Grouping of Chemicals to Assess Risks to Human Health

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