Light White Oils Exhibit Low Tissue Accumulation Potential and Minimal Toxicity in F344 Rats

McKee, Richard H.; Drummond, J.; Freeman, James J.; Letinski, Daniel J.; Miller, Mary J.

doi:10.1177/1091581811432940

Cited by 13 publications

(25 citation statements)

References 14 publications

(47 reference statements)

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“…S-C25 ranged from n-C 16 to n-C 34 , but the MOSH recovered from the liver and spleen (400 mg/kg dose) only started at about n-C 20 (which is in agreement with McKee et al, 2012). The n-alkanes were not detectable in liver and spleen.…”

Section: Molecular Mass Distributionsupporting

confidence: 75%

“…This may be the result of a different MOSH composition humans are exposed to or (more likely) to more time for exhalation. However, the finding of McKee et al (2012) that no MOSH up to n-C 20 are accumulated in rat livers, and onto which the BfR based the migration limit of 4 mg/kg for the MOSH C 17 -C 20 (Bfr, 2012), is not confirmed (Bfr, 2012).…”

Section: Figurementioning

confidence: 93%

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Bioaccumulation and toxicity of mineral oil hydrocarbons in rats ‐ specificity of different subclasses of a broad mixture relevant for human dietary exposures

Cravedi¹,

Grob²,

Nygaard

et al. 2017

EFSA Supporting Publications

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The purpose of this study was to investigate the fate and effects of mineral oil saturated hydrocarbons (MOSH) in female Fischer 344 rats. Animals were fed control diet or diet containing various MOSH mixtures at concentrations ranging from 40 to 4000 mg/kg feed for up to 120 days. MOSH were analysed in liver, spleen, adipose tissue and remaining carcass at different sampling times. In addition to clinical effects, liver microgranulomas, hepatic inflammation, and disruption of the immune function were the main toxicological endpoints investigated. Arthritis symptoms were specifically studied in dark agouti rats. The results indicate that accumulation of MOSH depends on the mixture tested but always occurred predominantly in the liver and to a lesser extent in adipose tissue and spleen. Strong differences exist between liver and adipose tissue in terms of accumulated hydrocarbons: whereas in adipose tissue the accumulated fraction corresponds to the most volatile part of the administered mixture, in the liver, the most volatile as well as the highest boiling part of the mixture are almost absent. Also the types of hydrocarbons differ. When exposure ceases, a significant decrease of MOSH concentration was observed in the liver, but not in adipose tissue. MOSH exposure results in a significant increase in absolute and relative liver weights, the effect being dose-related, but also dependent on the mixture tested. There were large differences in the ability of the different mixtures to induce liver granulomas. The highest incidence was observed with the mixture containing the highest proportion of n-alkanes, suggesting that this fraction could play a significant role in the development of hepatic granulomas. No effects were found on the immune function, irrespective of the mixture or the dose tested.

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Section: Molecular Mass Distributionsupporting

confidence: 75%

Section: Figurementioning

confidence: 93%

Bioaccumulation and toxicity of mineral oil hydrocarbons in rats ‐ specificity of different subclasses of a broad mixture relevant for human dietary exposures

Cravedi¹,

Grob²,

Nygaard

et al. 2017

EFSA Supporting Publications

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“…Several studies exist in which female F-344 rats were exposed subchronically to diets of different concentrations ranging from 0.004% to 2% (Figures 6-8) (Firriolo et al 1995;Griffis et al 2010;McKee et al 2012;Barp et al 2017aBarp et al , 2017b. Here, the MOSH levels in liver increased less than proportional with dietary concentration.…”

Section: Mosh Levels In Animal Tissuesmentioning

confidence: 94%

“…methylated) derivatives. Adapted from Miller et al (1996), EFSA (2012), McKee et al (2012), Barp et al (2017b) and Cravedi et al (2017). Mineral-oil type abbreviation: N: naphthenic (crude oil source); P: paraffinic; H: hydro-treated (catalytic hydrogenation); A: acid-treated; number (15, 70, 100): approximate viscosity (mm 2 /s) at 40 C.…”

Section: Introductionmentioning

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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“…In a study of higher molecular weight aliphatic constituents, female F-344 rats were fed diets containing 0.02%, 0.2%, or 2% of a white mineral oil (equivalent to approximately 20, 200, or 2000 mg/kg/day) with an average carbon number of C20, on a daily basis for 90 days (McKee et al 2012). At the end of the scheduled treatment period, the rats were sacrificed and examined for evidence of toxicologically relevant findings.…”

Section: Repeated Dose Studiesmentioning

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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Light White Oils Exhibit Low Tissue Accumulation Potential and Minimal Toxicity in F344 Rats

Cited by 13 publications

References 14 publications

Bioaccumulation and toxicity of mineral oil hydrocarbons in rats ‐ specificity of different subclasses of a broad mixture relevant for human dietary exposures

Bioaccumulation and toxicity of mineral oil hydrocarbons in rats ‐ specificity of different subclasses of a broad mixture relevant for human dietary exposures

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

Characterization of the toxicological hazards of hydrocarbon solvents

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