A GHS-consistent approach to health hazard classification of petroleum substances, a class of UVCB substances

Clark, Charles R.; McKee, Richard H.; Freeman, James J.; Swick, Derek; Mahagaokar, Suneeta; Pigram, Glenda; Roberts, Linda G.; Smulders, Chantal; Beatty, Patrick W.

doi:10.1016/j.yrtph.2013.08.020

Cited by 26 publications

(29 citation statements)

References 56 publications

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“…Mineral oils (C 15 -C 50 ) were mostly tested in chronic bioassays (see below), with the exception of one highly solvent-refined mineral oil stream, which was tested in both kinds of protocols (Skisak et al 1994). Substances of other petroleum-derived categories with lower carbon number ranges were tested as well, including kerosenes (C 9 -C 16 ) such as jet fuel, gas oils (C 9 -C 30 ) such as diesel fuel, and hydrocarbon solvents (C 5 -C 20 ) (Clark et al 2013;McKee and White 2014;McKee et al 2015). These substance mixtures represent, together with mineral oils, relevant sources of food contamination (see Chapter "Evaluation of mineral oil hydrocarbons in food by the EFSA CONTAM Panel") so that they are briefly discussed below with respect to their carcinogenic properties.…”

Section: Carcinogenicity Of Pahs and Moahmentioning

confidence: 99%

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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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Section: Carcinogenicity Of Pahs and Moahmentioning

confidence: 99%

“…Some gas oils contain aromatic constituents with more than three rings in toxicologically relevant concentrations which induce skin tumors in mice via genotoxicity (Clark et al 2013;McKee and White 2014). In addition, kerosenes, gas oils, and hydrocarbon solvents can produce skin tumors.…”

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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“…Hydrocarbon solvent toxicology 299 DOI 10.3109/10408444.2015.1016216 As a means of grouping those substances that are "similar", the hydrocarbon solvent industry has utilized the concepts of substance categories and "reasonable worst case" examples. A category is a group of substances with similar properties, such that the results of a study of any category member would be broadly applicable to all other category members (see Clark et al 2013, for an example of a similar approach for petroleum products). According to the Organization for Economic Cooperation and Development (OECD), a chemical category is a group of substances with physiochemical and toxicological properties that follow a regular pattern as a result of structural similarities, that is, the structural similarities create a predictable pattern in biological response (OECD 2007).…”

Section: Hydrocarbon Solvent Categoriesmentioning

confidence: 99%

“…However, the guidance on GHS classification does not define UVCB substances, nor does it explain how the GHS framework should be applied to complex substances. Recognizing this limitation, an approach that could be used as a means to classify UVCB substances was proposed, using petroleum substances as an example (Clark et al 2013). The guidance provided was essentially to divide the substances into categories, to use generic information on representative substances as the basis for classification, and to take specific constituents with unique properties into account, and can be directly applied to hydrocarbon solvents.…”

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confidence: 99%

Characterization of the toxicological hazards of hydrocarbon solvents

McKee

Adenuga

Carrillo

2015

Critical Reviews in Toxicology

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Hydrocarbon solvents are liquid hydrocarbon fractions derived from petroleum processing streams, containing only carbon and hydrogen atoms, with carbon numbers ranging from approximately C5-C20 and boiling between approximately 35-370°C. Many of the hydrocarbon solvents have complex and variable compositions with constituents of 4 types, alkanes (normal paraffins, isoparaffins, and cycloparaffins) and aromatics (primarily alkylated one-and tworing species). Because of the compositional complexity, hydrocarbon solvents are now identified by a nomenclature ("the naming convention") that describes them in terms of physical/ chemical properties and compositional elements. Despite the compositional complexity, most hydrocarbon solvent constituents have similar toxicological properties, and the overall toxicological hazards can be characterized in generic terms. To facilitate hazard characterization, the solvents were divided into 9 groups (categories) of substances with similar physical and chemical properties. Hydrocarbon solvents can cause chemical pneumonitis if aspirated into the lung, and those that are volatile can cause acute CNS effects and/or ocular and respiratory irritation at exposure levels exceeding occupational recommendations. Otherwise, there are few toxicologically important effects. The exceptions, n-hexane and naphthalene, have unique toxicological properties, and those solvents containing constituents for which classification is required under the Globally Harmonized System (GHS) are differentiated by the substance names. Toxicological information from studies of representative substances was used to fulfill REACH registration requirements and to satisfy the needs of the OECD High Production Volume (HPV) initiative. As shown in the examples provided, the hazard characterization data can be used for hazard classification and for occupational exposure limit recommendations. Introduction Scope and purpose of the documentThe present document summarizes information on the physical/ chemical properties and toxicological hazards of hydrocarbon solvents and provides examples of the ways in which the information on hazard characterization can be used for hazard classification and to set occupational exposure limits. Many of the toxicological studies were published separately, but the results are summarized herein and referenced in the appendices.Hydrocarbon solvents are liquid hydrocarbon fractions that are primarily produced by the distillation of petroleum feed stocks or their synthetic analogs (e.g., Fischer-Tropsch derived materials), sometimes followed by additional processing steps such as solvent extraction, hydrodesulfurization, or hydrogenation. 1 Most hydrocarbon solvents are complex substances with variable compositions and are best described as UVCB 2 (unknown and variable composition) substances, but some are single constituent (mono-constituent) substances. The complex and variable nature of these solvents is the consequence of their manufacturing processes. In short, most hydroca...

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“…32,33 The first version of the document, called Guidance on the application of GHS criteria to petroleum substances, identifies the constituents of concern for crude oil as hydrogen sulfide, benzene, and PACs. It guides the user through the GHS criteria to meet national and international standards for classification and labeling.…”

Section: Smentioning

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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A GHS-consistent approach to health hazard classification of petroleum substances, a class of UVCB substances

Cited by 26 publications

References 56 publications

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

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

Characterization of the toxicological hazards of hydrocarbon solvents

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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