Comparative toxicokinetics of low-viscosity mineral oil in Fischer 344 rats, Sprague–Dawley rats, and humans – Implications for an Acceptable Daily Intake (ADI)

Boogaard, Peter J.; Goyak, Katy O.; Biles, Robert W.; Stee, L.L.P. van; Miller, Matthew S.; Miller, Mary J.

doi:10.1016/j.yrtph.2012.02.014

Cited by 16 publications

(19 citation statements)

References 12 publications

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“…The question of strain specificity has been recently investigated by a pharmacokinetic study 13,14 in which it was shown that F344 rats exhibited higher oral bioavailability of a P15H oil than did SD rats. Further, at dose levels associated with no adverse effects when administered repeatedly in subchronic oral toxicity studies (20 mg/kg in F344 rats and 1500 mg/kg in SD rats), the blood concentrations in both rat strains approximated 6 mg/mL.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2012

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Female F344 rats were fed diets containing 0.02%, 0.2%, or 2.0% white mineral oil for 90 days. There were no gross or microscopic differences in target organs at the 0.02% level. In the higher-dose groups, relative liver and mesenteric lymph node (MLN) weights were increased, and MLN inflammation was observed. At the 2% level, there was very limited evidence of microgranuloma formation in the liver but at a lower incidence and at lesser severity than has been reported in studies of C₂₂-C₂₅ oils. Analysis of liver extracts from treated rats revealed that C₁₅-C₂₀ constituents were underrepresented by comparison to their corresponding concentrations in the test oil. These results provide evidence that although hydrocarbons with carbon numbers < C₂₀ are absorbed, they are not preferentially retained and do not contribute to inflammatory processes in liver.

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Section: Introductionmentioning

confidence: 99%

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

et al. 2012

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“…In conclusion, mineral oils and waxes are hardly absorbed by the skin and do not therefore present a systemic health risk to the consumer even after repeated and long‐term cutaneous exposure . Considering oral route, intestinal absorption of MOSH in rats was found to be inversely proportional to the number of carbon atoms, and a negligible absorption has been shown in humans with a 1 mg/kg dose of a low viscosity white oil . MOSH are metabolized to fatty alcohols and fatty acids by the small intestine and the liver.…”

Section: Pharmacological Datamentioning

confidence: 99%

“…In nine healthy female subjects aged 20–31 years and receiving a single oral dose (1 mg/kg) of a low viscosity Class III mineral oil, blood concentration of hydrocarbons (C19–C24) was below the detection limit of 0.16 μg/mL at all time points (1–168 h) . This toxicokinetic study thus concluded to a negligible absorption of a low viscosity white mineral oil at a dietary exposure of 1 mg/kg, which can reflect daily oral exposure to lip care products (see below section Exposure estimation to MOSH/MOAH via lipstick use).…”

Section: Pharmacological Datamentioning

confidence: 99%

“…Based on MOSH contents up to 74% in lip balms, their contribution to MOSH exposure can be estimated up to 0.7 mg/kg/day for a 60 kg person, thus representing <10% of the ADI value of 12 mg/kg/day set for the highly refined mineral oils used in these products . As a reminder, a similar oral dose (1 mg/kg) of white mineral oils administered to volunteers led to undetectable hydrocarbons (C19–C24) in blood . Moreover, the presence of MOSH and MOAH in itself is not indicative of any carcinogenic potential and highly refined mineral oils are almost devoid of potentially harmful PAH.…”

Section: Exposure Estimation To Mosh/moah Via Lipstick Usementioning

confidence: 99%

“…8 Considering oral route, intestinal absorption of MOSH in rats was found to be inversely proportional to the number of carbon atoms, and a negligible absorption has been shown in humans with a 1 mg/kg dose of a low viscosity white oil. 16 MOSH are metabolized to fatty alcohols and fatty acids by the small intestine and the liver. MOAH are well absorbed and extensively metabolized by a similar route and do not bioaccumulate.…”

Section: Oral Absorptionmentioning

confidence: 99%

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Mineral oils and waxes in cosmetics: an overview mainly based on the current European regulations and the safety profile of these compounds

Chuberre

Araviiskaia

Bieber

et al. 2019

Acad Dermatol Venereol

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Mineral oils and waxes are mixtures of predominantly saturated hydrocarbons consisting of straight‐chain, branched and ring structures with carbon chain lengths greater than C14. They have been used for many decades in skin and lip care cosmetic products due to their excellent skin tolerance as well as their high protecting and cleansing performance and broad viscosity options. In contrast to vegetable oils, mineral oils are non‐allergenic since they are highly stable and not susceptible to oxidation or rancidity. They have a long history of safe use which is confirmed by clinical and epidemiological data. In Europe, mineral oils are only permitted in cosmetics if compliant with purity specifications on polycyclic aromatic hydrocarbons and safety requirements laid down in the European pharmacopoeia and the EU cosmetics regulation EC/1223/2009. The high quality of these mineral oils is assured by robust quality assurance and a refining/purification process designed to exclude substances with carcinogenic potential and to minimize the presence of mineral oil aromatic hydrocarbons. Given their highly lipophilic properties, mineral oils do not penetrate human skin and, thus, are not systemically bioavailable in the body. Moreover, no significant changes in the skin and no effects on any internal organ system have been reported and attributed to the topical application of refined mineral oils. Regarding potential oral exposure from cosmetic lip care products, Cosmetics Europe, the European trade association for the cosmetics and personal care industry, has advised cosmetic manufacturers to only use mineral oil fractions for which recognized food acceptable daily intake (ADI) values apply. The estimated dose of mineral oils ingested via lip care products contributes to <10% of the ADI value and should therefore be considered of no toxicological concern.

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Evolution of hyphenated techniques for mineral oil analysis in food

Sdrigotti

Collard

Purcaro

2020

J of Separation Science

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The occurrence of mineral oil in food is known since the early 1990s, and it was discovered by chance in one of the first applications using the hyphenated LC–GC system. Since then, the relationship between hyphenated techniques and mineral oil analysis has been tightly interrelated and successful. This review aims to show and explain how this mutual interaction has driven the development of the hyphenated techniques on one side and has supported the increase of knowledge on the other, supporting the complex task of mineral oil determination in food. The paper presents the background of the mineral oil problem in food (a brief history of its finding, toxicology, and occurrence), moving then toward the analytical determination. The development of different hyphenated techniques in relation to mineral oil determination is discussed, focusing mainly on 2D techniques, such as LC–GC. The necessity of additional dimensions, such as LC–LC–GC and comprehensive approaches, such as GC × GC and LC × GC, is also discussed. Finally, the role of the hyphenation with MS is presented.

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Comparative toxicokinetics of low-viscosity mineral oil in Fischer 344 rats, Sprague–Dawley rats, and humans – Implications for an Acceptable Daily Intake (ADI)

Cited by 16 publications

References 12 publications

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

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

Mineral oils and waxes in cosmetics: an overview mainly based on the current European regulations and the safety profile of these compounds

Evolution of hyphenated techniques for mineral oil analysis in food

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