Assessing the mammalian toxicity of high-boiling petroleum substances under the rubric of the HPV program

Gray, Thomas M.; Simpson, Bob; Nicolich, Mark J.; Murray, F. Jay; Verstuyft, Allen W.; Roth, Randy N.; McKee, Richard H.

doi:10.1016/j.yrtph.2012.11.014

Cited by 30 publications

(27 citation statements)

References 18 publications

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“…20, 28, 29 ARC profiles 28 of the substances tested in our study comprised of sample-specific weight percentages for aromatic compounds containing 1 through 7 rings. 30 Total weight percentages of aromatic compounds were obtained across all petroleum substances as detailed in Methods, they ranged between 2.1 and 9.9% (4.7–6.5% for SRGOs, 2.3–6.6% for OGOs, 2.1–9.9% for VHGOs, and 2.3–5.4% for HFOs).…”

Section: Resultsmentioning

confidence: 99%

Grouping of Petroleum Substances as Example UVCBs by Ion Mobility-Mass Spectrometry to Enable Chemical Composition-Based Read-Across

Grimm

Russell

Luo

et al. 2017

Environ. Sci. Technol.

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Substances of Unknown or Variable composition, Complex reaction products, and Biological materials (UVCBs), including many refined petroleum products, present a major challenge in regulatory submissions under the EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and US High Production Volume regulatory regimes. The inherent complexity of these substances, as well as variability in composition obfuscates detailed chemical characterization of each individual substance and their grouping for human and environmental health evaluation through read-across. In this study, we applied ion mobility mass spectrometry in conjunction with cheminformatics-based data integration and visualization to derive substance-specific signatures based on the distribution and abundance of various heteroatom classes. We used petroleum substances from four petroleum substance manufacturing streams and evaluated their chemical composition similarity based on high-dimensional substance-specific quantitative parameters including m/z distribution, drift time, carbon number range, and associated double bond equivalents and hydrogen-to-carbon ratios. Data integration and visualization revealed group-specific similarities for petroleum substances. Observed differences within a product group were indicative of batch- or manufacturer-dependent variation. We demonstrate how high-resolution analytical chemistry approaches can be used effectively to support categorization of UVCBs based on their heteroatom composition and how such data can be used in regulatory decision-making.

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Section: Resultsmentioning

confidence: 99%

Grouping of Petroleum Substances as Example UVCBs by Ion Mobility-Mass Spectrometry to Enable Chemical Composition-Based Read-Across

Grimm

Russell

Luo

et al. 2017

Environ. Sci. Technol.

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“…For mineral oils, products with a high concentration of polycyclic aromatic compounds (PAC) with 3-7 rings (parent PAHs, short-alkylated MOAH, compounds containing heteroatoms), such as unrefined and poorly refined base oils, were carcinogenic in mouse skin painting assays (Roy et al 1988;McKee, Daughtrey, et al 1989;Blackburn et al 1996;Mackerer et al 2003). The aromatics concentration was determined by target analytics for specific parent PAHs (McKee, Daughtrey, et al 1989;Concawe 1994) and by solvent extraction with dimethyl sulfoxide (DMSO) followed by GC separation according to the ring number using two to seven ring unsubstituted PAHs as internal standards (Roy et al 1988;Mackerer et al 2003;Gray et al 2013). The latter technique is used by the Mobil PAC Method for predicting dermal carcinogenicity (see below).…”

Section: Carcinogenicity Of Pahs and Moahmentioning

confidence: 99%

Mineral oil in food, cosmetic products, and in products regulated by other legislations

Pirow

Blume

Hellwig

et al. 2019

Critical Reviews in Toxicology

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For a few years, mineral oils and their potential adverse health effects have been a constant issue of concern in many regulatory areas such as food, cosmetics, other consumer products, and industrial chemicals. Analytically, two fractions can be distinguished: mineral oil saturated hydrocarbons (MOSH) and mineral oil aromatic hydrocarbons (MOAH). This paper aims at assessing the bioaccumulative potential and associated histopathological effects of MOSH as well as the carcinogenic potential of MOAH for consumer-relevant mineral oils. It also covers the absorption, distribution, metabolism, and excretion of MOSH and MOAH upon oral and dermal exposures. The use and occurrence of consumerrelevant, highly refined mineral oils in food, cosmetics and medicinal products are summarized, and estimates for the exposure of consumers are provided. Also addressed are the challenges in characterizing the substance identity of mineral oil products under REACH. Evidence from more recent autopsy and biopsy studies, along with information on decreasing food contamination levels, indicates a low risk for adverse hepatic lesions that may arise from the retention of MOSH in the liver. With respect to MOAH, at present there is no indication of any carcinogenic effects in animals dermally or orally exposed to highly refined mineral oils and waxes. Such products are used not only in cosmetics but also in medicinal products and as additives in food contact materials. The safety of these mineral oilcontaining products is thus indirectly documented by their prevalent and long-term use, with a simultaneous lack of clinical and epidemiological evidence for adverse health effects.

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“… Abbreviations: DMSO, dimethyl sulfoxide; PAC, polycyclic aromatic compound. a As determined by PAC-2 method. 20–22 b “ARC 1%” is the weight percent (wt%) of PACs that have 1 aromatic ring within the total sample. “ARC 2%” is the percent of PACs with 2 aromatic rings, and so forth to 7 aromatic rings. …”

Section: Resultsmentioning

confidence: 99%

“… Abbreviations: BMD, benchmark dose; [Hb], hemoglobin content; NP, not predicted; PAC, polycyclic aromatic compound; PDR 10 , predicted dose for 10% change. a As determined by PAC-2 method. 20–22 b In those situations in which the test material has a dose–response curve that is relatively flat, the model may either predict a slightly increasing or slightly decreasing dose response (random variation problem). If the model predicts a dose response that is contrary to what is expected for the end point (say a slope of 0.01 where a negative slope is expected), then no model prediction is presented.…”

Section: Resultsmentioning

confidence: 99%

Use of a Statistical Model to Predict the Potential for Repeated Dose and Developmental Toxicity of Dermally Administered Crude Oil and Relation to Reproductive Toxicity

McKee

Nicolich²,

Roy

et al. 2013

Int J Toxicol

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Petroleum (commonly called crude oil) is a complex substance primarily composed of hydrocarbon constituents. Based on the results of previous toxicological studies as well as occupational experience, the principal acute toxicological hazards are those associated with exposure by inhalation to volatile hydrocarbon constituents and hydrogen sulfide, and chronic hazards are associated with inhalation exposure to benzene and dermal exposure to polycyclic aromatic compounds. The current assessment was an attempt to characterize the potential for repeated dose and/or developmental effects of crude oils following dermal exposures and to generalize the conclusions across a broad range of crude oils from different sources. Statistical models were used to predict the potential for repeated dose and developmental toxicity from compositional information. The model predictions indicated that the empirical data from previously tested crude oils approximated a ''worst case'' situation, and that the data from previously tested crude oils could be used as a reasonable basis for characterizing the repeated dose and developmental toxicological hazards of crude oils in general.

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Assessing the mammalian toxicity of high-boiling petroleum substances under the rubric of the HPV program

Cited by 30 publications

References 18 publications

Grouping of Petroleum Substances as Example UVCBs by Ion Mobility-Mass Spectrometry to Enable Chemical Composition-Based Read-Across

Grouping of Petroleum Substances as Example UVCBs by Ion Mobility-Mass Spectrometry to Enable Chemical Composition-Based Read-Across

Mineral oil in food, cosmetic products, and in products regulated by other legislations

Use of a Statistical Model to Predict the Potential for Repeated Dose and Developmental Toxicity of Dermally Administered Crude Oil and Relation to Reproductive Toxicity

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