Comparative Pharmacokinetic and Disposition Studies of [1-<sup>14</sup>C]1-Eicosanylcyclohexane, a Surrogate Mineral Hydrocarbon, in Female Fischer-344 and Sprague-Dawley Rats

Halladay, Jason; Mackerer, Carl R.; Twerdok, Lorraine E.; Sipes, I. G.

doi:10.1124/dmd.30.12.1470

Cited by 19 publications

(23 citation statements)

References 21 publications

(13 reference statements)

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“…Tulliez (1986) reported that ring hydroxylation may occur, resulting in the formation of cyclanols and subsequently to the production of free and conjugated hydroxylated cyclohexyl acids eliminated in urine (Figure 26). Halladay et al (2002) identified 12-cyclohexyldodecanoic acid and 10-cyclohexyldecanoic acid as the main metabolites in the urine of female Fischer 344 and Sprague Dawley rats administered a single dose of 1.8 g/kg b.w. eicosanylcyclohexane by gavage, confirming the ω-oxidation of the alkyl chain previous observed by Tulliez and Bories (1979) with dodecylcyclohexane.…”

Section: Moshmentioning

confidence: 99%

“…In order to study the rat strain differences in the toxicokinetics of mineral hydrocarbons, Halladay et al (2002) In particular, a triphasic absorption profile with two peak concentrations in blood (the first after 6 hours and the second after 16 hours after the administration) was observed in Fischer 344, but not in Sprague Dawley rats at the lower tested dose. The two concentration peaks observed in Fischer 344 females were attributed to two independent routes of absorption, the fastest one occurring through the hepatic portal system and the second through the lymphatic system.…”

Section: Individual Compoundsmentioning

confidence: 99%

“…The excretion profile of ([ 14 C]-EICO) was studied in female Fischer 344 and Sprague Dawley rats by Halladay et al (2002). Rats were administered a single dose of 0.18 or 1.8 g/kg b.w.…”

Section: Moshmentioning

confidence: 99%

“…The distribution of another radiolabelled cycloalkane, 14 C-eicosanylcyclohexane ( 14 C-EICO), was investigated by Halladay et al (2002) in Fischer 344 and Sprague Dawley female rats (see experimental conditions in Section 7.1.1). At the end of the experiment (96 hr postdose) approximately 3 % of administered radioactivity was present in the liver of Fischer 344 rats, whereas only 0.1 % remained in the liver of Sprague Dawley rats.…”

Section: Individual Compoundsmentioning

confidence: 99%

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Scientific Opinion on Mineral Oil Hydrocarbons in Food

2012

EFS2

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Consumers are exposed to a range of mineral oil hydrocarbons (MOH) via food. Mineral oil saturated hydrocarbons (MOSH) consist of linear and branched alkanes, and alkyl-substituted cyclo-alkanes, whilst mineral oil aromatic hydrocarbons (MOAH) include mainly alkyl-substituted polyaromatic hydrocarbons. Products, commonly specified according to their physico-chemical properties, may differ in chemical composition depending on the oil source. Technical grade MOH contain 15 -35 % MOAH, which is minimised in food grade MOSH (white oils). Major sources of MOH in food are food packaging and additives, processing aids, and lubricants. Estimated MOSH exposure ranged from 0.03 to 0.3 mg/kg b.w. per day, with higher exposure in children. Specific production practices of bread and grains may provide additional MOSH exposure. Except for white oils, exposure to MOAH is about 20 % of that of MOSH. Absorption of alkanes with carbon number above C 35 is negligible. Branched and cyclic alkanes are less efficiently oxidised than n-alkanes. MOSH from C 16 to C 35 may accumulate and cause microgranulomas in several tissues including lymph nodes, spleen and liver. Hepatic microgranulomas associated with inflammation in Fischer 344 rats were considered the critical effect. The no-observed-adverse-effect level for induction of liver microgranulomas by the most potent MOSH, 19 mg/kg b.w. per day, was used as a Reference Point for calculating margins of exposure (MOEs) for background MOSH exposure. MOEs ranged from 59 to 680. Hence, background exposure to MOSH via food in 1 On request from the European Commission, Question No EFSA-Q-2010-00170, adopted on 3 May 2012. 2 SUMMARYFollowing a request from the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) was asked to deliver a scientific opinion on mineral oil hydrocarbons (MOH) in Food. Mineral oil hydrocarbons occur in food both as a result of contamination and from various intentional uses in food production. In order to assess the need for possible regulatory measures as regards MOH in food, EFSA was requested to assess the risks related to their occurrence in food. More specifically, the opinion should evaluate whether new toxicity data are available and whether the current acceptable daily intakes (ADIs) are still applicable, explore whether certain classes (or subclasses) of MOH are more relevant due to their toxicity or to differences in the way they are metabolised by the human body, and identify the different background sources, other than from adulteration or misuse, of MOH occurrence in food. In addition a dietary exposure assessment was requested for the general population and for specific subgroups of the population (e.g. infants, children and people following specific diets), by taking into account the background occurrence of MOH in food. Included in the request was also to advise on MOH and food classes to be included if monitoring were to be set up for their presence in food.The scientific literature and other sources were s...

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Section: Moshmentioning

confidence: 99%

Section: Individual Compoundsmentioning

confidence: 99%

“…The excretion profile of ([ 14 C]-EICO) was studied in female Fischer 344 and Sprague Dawley rats by Halladay et al (2002). Rats were administered a single dose of 0.18 or 1.8 g/kg b.w.…”

Section: Moshmentioning

confidence: 99%

Section: Individual Compoundsmentioning

confidence: 99%

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Scientific Opinion on Mineral Oil Hydrocarbons in Food

2012

EFS2

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“…In studies of the metabolism of hydrocarbons with even longer chains, Halladay et al (2002) gave 1.8 g/kg bw of eicosanylcyclohexane (cyclic C26 aliphatic hydrocarbon) to Sprague-Dawley rats as single oral doses. The major metabolites identified (12-cyclohexyldodecanoic acid and 10-cyclohexyldecanoic acid) appeared to be products of w-oxidation of alkyl side chains.…”

Section: C14-c20 Hydrocarbon Solvent Constituentsmentioning

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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Weißöl, pharmazeutisch [MAK Value Documentation in German Language, 2015]

2015

The MAK‐Collection for Occupational Health and Safety

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Veröffentlicht in der Reihe Gesundheitsschädliche Arbeitsstoffe , 59. Lieferung, Ausgabe 2015 Der Artikel enthält folgende Kapitel: Allgemeiner Wirkungscharakter Wirkungsmechanismus Toxikokinetik und Metabolismus Aufnahme, Verteilung, Ausscheidung Metabolismus Erfahrungen beim Menschen Tierexperimentelle Befunde und In‐vitro‐Untersuchungen Akute Toxizität Subakute, subchronische und chronische Toxizität Wirkung auf Haut und Schleimhäute Allergene Wirkung Reproduktionstoxizität Genotoxizität Kanzerogenität Bewertung

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Comparative Pharmacokinetic and Disposition Studies of [1-¹⁴C]1-Eicosanylcyclohexane, a Surrogate Mineral Hydrocarbon, in Female Fischer-344 and Sprague-Dawley Rats

Cited by 19 publications

References 21 publications

Scientific Opinion on Mineral Oil Hydrocarbons in Food

Scientific Opinion on Mineral Oil Hydrocarbons in Food

Characterization of the toxicological hazards of hydrocarbon solvents

Weißöl, pharmazeutisch [MAK Value Documentation in German Language, 2015]

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Comparative Pharmacokinetic and Disposition Studies of [1-14C]1-Eicosanylcyclohexane, a Surrogate Mineral Hydrocarbon, in Female Fischer-344 and Sprague-Dawley Rats

Cited by 19 publications

References 21 publications

Scientific Opinion on Mineral Oil Hydrocarbons in Food

Scientific Opinion on Mineral Oil Hydrocarbons in Food

Characterization of the toxicological hazards of hydrocarbon solvents

Weißöl, pharmazeutisch [MAK Value Documentation in German Language, 2015]

Contact Info

Product

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Comparative Pharmacokinetic and Disposition Studies of [1-¹⁴C]1-Eicosanylcyclohexane, a Surrogate Mineral Hydrocarbon, in Female Fischer-344 and Sprague-Dawley Rats