A study of the toxicity of five mineral hydrocarbon waxes and oils in the F344 rat, with histological examination and tissue-specific chemical characterisation of accumulated hydrocarbon material

Scotter, Michael J.; Castle, Laurence; Massey, Robert C.; Brantom, Paul; Cunninghame, Morag E.

doi:10.1016/s0278-6915(02)00279-x

Cited by 36 publications

(42 citation statements)

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“…4-7,12 These changes were not observed when these substances were given to rats of other strains or to dogs. 2,3,5 The effects appear to be associated with selective retention of aliphatic hydrocarbons with carbon numbers ranging from C 20 to C 35 in liver and MLN, 7,8,11,21 and the strain and species differences seem to be a consequence of a higher rate of absorption and lower rate of metabolism in F344 rats by comparison to other strains. 8 This imbalance between uptake and metabolism results in accumulation of these hydrocarbons in liver and MLN, leading to inflammatory processes, 12 and ultimately to the formation of microgranulomas.…”

Section: Discussionmentioning

confidence: 99%

“…In analyses of liver extracts from F344 rats, molecules with carbon numbers ranging from C 20 to C 30 are found at levels greater than those in the corresponding oils, suggesting selective accumulation as described above. Molecules with carbon numbers less than C 20 are found at levels below those in the corresponding mineral oils, 7,11 and, as hydrocarbons with carbon numbers in this range are relatively well absorbed, are presumed to be relatively rapidly excreted. However, molecules with carbon numbers <C 20 have been less well studied in this respect as research has focused on mineral oils and waxes with constituents primarily in the C 20 to C 30 range.…”

Section: Discussionmentioning

confidence: 99%

“…It was hypothesized that preferential accumulation of constituents in the C 20 -C 35 carbon number range by F344 rats led to the development of the characteristic effects of these substances. 7,8 Hydrocarbons with carbon numbers >C 35 are not well absorbed 9,10 and are unlikely to make substantial contributions to the development of these effects. These studies as well as other studies of white mineral oils and low melting point waxes 11,12 provided evidence that constituents with carbon numbers <C 20 were also not preferentially accumulated, but as these lower molecular weight constituents represented relatively small fractions of the tested oils, the relationship between the characteristic histological changes and low-molecular-weight hydrocarbons was less well defined.…”

Section: Introductionmentioning

confidence: 99%

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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: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2012

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“…The histological findings were limited to evidence of microgranuloma formation in the livers and mesenteric lymph nodes in the animals of the highdose group. The principal objective of this study was to examine the potential for mineral oils to accumulate in the liver and mesenteric lymph nodes, an effect previously reported to occur in F-344 rats but not in rats of other strains or animals of other species (Baldwin et al 1992, Bird et al 1990, Firriolo et al 1995, 1996, Scotter et al 2003. A principal finding was that the hydrocarbons that preferentially accumulated in the liver, leading to granuloma formation, had carbon numbers  C20.…”

Section: Repeated Dose Studiesmentioning

confidence: 94%

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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“…Urinary elimination (mean 0.16 % of the dose) and bile excretion (mean 0.01 % of the dose) were very low. Scotter et al, (2003) conducted detailed mineral MHC analysis of tissues following oral administration of various white oils, including P70, for 90 days. No histopathological evidence of MHC accumulation was detected in any tissues from F344 rats fed 2 % P70 oil (mean dose = 2116 mg/kg bw/day) for 90 days.…”

Section: Introductionmentioning

confidence: 99%

Scientific Opinion on the use of high viscosity white mineral oils as a food additive

Publication¹

2009

EFSA Journal

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The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on the safety of high viscosity white mineral oils (HVMO) (CAS Registry Number 8042-47-5) when used as food additives. HVMO have previously been evaluated by the EC Scientific Committee for Food (SCF) (1995) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) (1995, 2002). The SCF allocated a Temporary Group ADI of 0-4 mg/kg bw/day for white paraffinic oils which included white mineral oils with a viscosity higher than 8.5 cSt at 100°C. In 2002, JECFA recommended an ADI of 0 -20 mg/kg bw/day for HVMO. Dietary exposure to HVMO did not produce adverse effects in subchronic toxicity and chronic toxicity/carcinogenicity studies in rats. Infiltration of histiocytes (granulomas) in mesenteric lymph nodes and oil deposition in the liver were considered to be an indication of exposure to white mineral oils rather than an adverse effect. The NOAEL for HVMO was considered to be 1200 mg/kg bw/day, the highest dose tested. Using this NOAEL and applying an uncertainty factor of 100 the Panel established an ADI of 12 mg/kg bw/day for HVMO (kinematic viscosity ≥ 11 mm²/s (cSt) at 100 °C, a carbon number > 28 at 5 % distillation point and an average molecular weight > 500 g/mol). The Panel considered the dietary exposure to HVMO from current uses as well as proposed uses, and estimated that the potential dietary exposures for high level consumers (95 th /97.5 th ) would reach up to approximately 13 mg/kg bw/day for adults and 19 mg/kg bw/day for children. The Panel considers these estimates to be very conservative since high levels of exposure from different sources, in consumers only, have been added up. KEY WORDSHigh viscosity white mineral oils; CAS Number 8042-47-5; Liquid paraffin; Paraffinum Liquidum. SUMMARYFollowing a request from the European Commission to the European Food Safety Authority, the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to evaluate the safety-in-use of high viscosity white mineral oils as food additives.In 1995, the EC Scientific Committee for Food (SCF) (1995) evaluated the safety of mineral and synthetic hydrocarbon oils and waxes for use as food additives, in food processing and for use in food packaging materials. The SCF did not allocate an Acceptable Daily Intake (ADI) for those products which, in F344 rats, showed accumulation of hydrocarbons in the liver and lymph nodes associated with a granulomatous response, since it was felt that from the 90-day studies available at that time it was not possible to set a safe level for intake from food. These products included white mineral oils with a viscosity equal to or less than 8.5 cSt at 100°C. For the mineral hydrocarbon products which showed no or minimal accumulation and no toxicity within the duration of a 90-day study in rats the SCF allocated a Temporary Group ADI of 0-4 mg/kg bw for white paraffinic oils. These products included white mineral oils with a viscosity higher than 8.5 ...

show abstract

A study of the toxicity of five mineral hydrocarbon waxes and oils in the F344 rat, with histological examination and tissue-specific chemical characterisation of accumulated hydrocarbon material

Cited by 36 publications

References 10 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

Characterization of the toxicological hazards of hydrocarbon solvents

Scientific Opinion on the use of high viscosity white mineral oils as a food additive

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