Evaluation of time extrapolation factors based on the database RepDose

Batke, Monika; Escher, Sylvia; Hoffmann-Doerr, Simone; Melber, Christine; Messinger, Horst; Mangelsdorf, Inge

doi:10.1016/j.toxlet.2011.05.1030

Cited by 35 publications

(15 citation statements)

References 13 publications

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“…Therefore, in addition to the fact that the POD distributions of Class II and III are not significantly different, the possibility still exists that the chemical space of Class II for cosmetics-related chemicals may be different than that of other chemicals. The difficulty of finding sufficient chemicals to populate Cramer Class II and provide a meaningful analysis has been noted by others using different databases (Batke et al, 2011;EFSA, 2012;Escher et al, 2010;Feigenbaum et al, 2015;Munro et al, 1996;Pinalli et al, 2011;Tluczkiewicz et al, 2011). The present study also found that there were insufficient chemicals in Cramer Class II for a meaningful analysis and derivation of a reliable TTC value for this Cramer Class with the database at hand.…”

Section: The Effect Of Cramer Classificationssupporting

confidence: 56%

Thresholds of Toxicological Concern for cosmetics-related substances: New database, thresholds, and enrichment of chemical space

Yang

Barlow²,

Jacobs

et al. 2017

Food and Chemical Toxicology

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a b s t r a c tA new dataset of cosmetics-related chemicals for the Threshold of Toxicological Concern (TTC) approach has been compiled, comprising 552 chemicals with 219, 40, and 293 chemicals in Cramer Classes I, II, and III, respectively. Data were integrated and curated to create a database of No-/Lowest-Observed-AdverseEffect Level (NOAEL/LOAEL) values, from which the final COSMOS TTC dataset was developed. Criteria for study inclusion and NOAEL decisions were defined, and rigorous quality control was performed for study details and assignment of Cramer classes. From the final COSMOS TTC dataset, human exposure thresholds of 42 and 7.9 mg/kg-bw/day were derived for Cramer Classes I and III, respectively. The size of Cramer Class II was insufficient for derivation of a TTC value. The COSMOS TTC dataset was then federated with the dataset of Munro and colleagues, previously published in 1996, after updating the latter using the quality control processes for this project. This federated dataset expands the chemical space and provides more robust thresholds. The 966 substances in the federated database comprise 245, 49 and 672 chemicals in Cramer Classes I, II and III, respectively. The corresponding TTC values of 46, 6.2 and 2.3 mg/kg-bw/day are broadly similar to those of the original Munro dataset.

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Section: The Effect Of Cramer Classificationssupporting

confidence: 56%

Thresholds of Toxicological Concern for cosmetics-related substances: New database, thresholds, and enrichment of chemical space

Yang

Barlow²,

Jacobs

et al. 2017

Food and Chemical Toxicology

View full text Add to dashboard Cite

show abstract

“…Munro et al (1996) and RepDose (Escher et al, 2010;Batke et al, 2011) databases contain few chemicals in Cramer Class II, suggesting that this class may be of limited practical utility. A question already raised in the ILSI workshop (Dewhurst and Renwick, 2013) is whether the current delineation between the cancer and non-cancer tiers in the Kroes et al (2005) scheme, which is based on the presence of structural alerts for genotoxicity, is adequate.…”

Section: "If Most Endpoints For Most Agents Are Assumed To Have Non-zmentioning

confidence: 99%

Thresholds of Toxicological Concern – Setting a threshold for testing below which there is little concern

Hartung

2017

ALTEX

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“…The Cramer decision tree assigns chemicals into one of three broad classes based on the presence of potentially toxic chemical functional groups within the molecule; it was developed in the 1970s (Cramer et al, 1978) on a relatively limited set of chemicals. Munro et al (1996a) and RepDose Batke et al, 2011) databases contain few chemicals in Cramer Class II suggesting that this may be of limited practical utility. Does the Cramer classification system require revising?…”

Section: Non-cancer Breakout Groupsmentioning

confidence: 99%

Evaluation of the Threshold of Toxicological Concern (TTC) – Challenges and approaches

Dewhurst

Renwick

2013

Regulatory Toxicology and Pharmacology

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Evaluation of time extrapolation factors based on the database RepDose

Cited by 35 publications

References 13 publications

Thresholds of Toxicological Concern for cosmetics-related substances: New database, thresholds, and enrichment of chemical space

Thresholds of Toxicological Concern for cosmetics-related substances: New database, thresholds, and enrichment of chemical space

Thresholds of Toxicological Concern – Setting a threshold for testing below which there is little concern

Evaluation of the Threshold of Toxicological Concern (TTC) – Challenges and approaches

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