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Link to original content: http://pubmed.ncbi.nlm.nih.gov/37711880/
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Update of the risk assessment of mineral oil hydrocarbons in food

EFSA Panel on Contaminants in the Food Chain (CONTAM) et al. EFSA J. .

Abstract

Mineral oil hydrocarbons (MOH) are composed of saturated hydrocarbons (MOSH) and aromatic hydrocarbons (MOAH). Due to the complexity of the MOH composition, their complete chemical characterisation is not possible. MOSH accumulation is observed in various tissues, with species-specific differences. Formation of liver epithelioid lipogranulomas and inflammation, as well as increased liver and spleen weights, are observed in Fischer 344 (F344) rats, but not in Sprague-Dawley (SD) rats. These effects are related to specific accumulation of wax components in the liver of F344 rats, which is not observed in SD rats or humans. The CONTAM Panel concluded that F344 rats are not an appropriate model for effects of MOSH with wax components. A NOAEL of 236 mg/kg body weight (bw) per day, corresponding to the highest tested dose in F344 rats of a white mineral oil product virtually free of wax components, was selected as relevant reference point (RP). The highest dietary exposure to MOSH was estimated for the young population, with lower bound-upper bound (LB-UB) means and 95th percentiles of 0.085-0.126 and 0.157-0.212 mg/kg bw per day, respectively. Considering a margin of exposure approach, the Panel concluded that the present dietary exposure to MOSH does not raise concern for human health for all age classes. Genotoxicity and carcinogenicity are associated with MOAH with three or more aromatic rings. For this subfraction, a surrogate RP of 0.49 mg/kg bw per day, calculated from data on eight polycyclic aromatic hydrocarbons, was considered. The highest dietary exposure to MOAH was also in the young population, with LB-UB mean and 95th percentile estimations of 0.003-0.031 and 0.011-0.059 mg/kg bw per day, respectively. Based on two scenarios on three or more ring MOAH contents in the diet and lacking toxicological information on effects of 1 and 2 ring MOAH, a possible concern for human health was raised.

Keywords: MOAH; MOSH; Mineral oil hydrocarbons (MOH); alkanes; aromatic hydrocarbons; human dietary exposure; toxicity.

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Figures

Figure 1
Figure 1
Examples of hydrocarbons for the different classes found in crude mineral oil, whereby the low molecular mass species are outside the definition of MOH used for this opinion. Figure adapted from the EFSA opinion 2012
Figure 2
Figure 2
Number of samples with data on MOAH and/or MOSH
Figure 3
Figure 3
Number of samples by sampling country

  1. (a): Samples reported by European food associations without specifying the sampling country.

Figure 4
Figure 4
Number of samples by sampling year
Figure 5
Figure 5
Percentage of quantified, non‐quantified and non‐detected analytical results across the different C‐fractions
Figure B.1
Figure B.1
Relative retention of MOSH in liver, spleen and adipose tissue (40 mg/kg dose; 90 + 30 days exposure). Adapted from Cravedi et al. (2017) © INRA, KLZ, NIPH. Barp et al. (2017a)
Figure B.2
Figure B.2
GC × GC /FID of the MOSH added to the feed (upper left) and in the extracts of adipose tissue, liver and spleen from F344 rats exposed to the 400 mg/kg dose during 120 days. Cycy and Cho, internal standards. Attenuation adjusted to result in similar intensity. Adapted from Cravedi et al. (2017) © INRA, KLZ, NIPH. Barp et al. (2017a)
Figure B.3
Figure B.3
HPLC‐GC‐FID chromatograms of the three MOSH mixtures tested in the second part of the EFSA‐sponsored study. Internal standards in Italics: n‐alkanes C11, C13 and C17, cyclohexyl cyclohexane (Cycy) and cholestane (Cho). Adapted from Cravedi et al. (2017) © INRA, KLZ, NIPH. Barp et al. (2017b)
Figure B.4
Figure B.4
Comparison of HPLC‐GC‐FID chromatograms of extracts from the tissues (upper chromatograms in red) with the corresponding MOSH mixtures applied (lower chromatograms in black). 400 mg/kg doses; 90 days. Adapted from Cravedi et al. (2017) © INRA, KLZ, NIPH. Barp et al. (2017b).
Figure B.5
Figure B.5
Extract from Figure B.4 focusing on the S‐C25 oil and the adipose tissue, showing that the n‐alkanes ranging up to about C22 (green arrows), then disappeared in other signals, particularly the little branched alkanes
Figure B.6
Figure B.6
Extract from Figure B.4 focusing on the S‐C25 oil and the MOSH in the spleen, showing the almost complete absence of n‐alkanes in the spleen
Figure B.7
Figure B.7
Extract from Figure B.4 focusing on the S‐C25 oil and the MOSH in the liver, showing the almost complete absence of peaks related to n‐alkanes
Figure B.8
Figure B.8
Extract from Figure B.4 focusing on the L‐C25 oil and the MOSH in the adipose tissue and the spleen, analogous to Figures B.5 and B.6. The concentration of the n‐alkanes was lower than after administration of S‐C25, but they were still present
Figure B.9
Figure B.9
Sections of the GC × GC‐FID plots of the S‐C25 oil (top) and its residues in the tissues (400 mg/kg dose). Green lines point out the n‐alkanes that are barely visible. Axes as in Figure B.2. Adapted from Cravedi et al. (2017) © INRA, KLZ, NIPH. Barp et al. (2017b)
Figure B.10
Figure B.10
Sections of the GC × GC‐FID plots of L‐C25 and its residues in the tissues (400 mg/kg dose). Green lines point out the n‐alkanes, which produced small, but visible signals. Axes as in Figure B.2. Adapted from Cravedi et al. (2017) © INRA, KLZ, NIPH. Barp et al. (2017b)
Figure B.11
Figure B.11
Sections of the GC × GC‐FID plots of L‐C25W and its residues in the tissues (400 mg/kg dose). Axes as in Figure B.2. Adapted from Cravedi et al. (2017) © INRA, KLZ, NIPH. Barp et al. (2017b)
Figure C.1
Figure C.1
Subjects sorted by age, with females in grey and males in black (modified from Barp et al., . © Elsevier Ltd)
Figure C.2
Figure C.2
MOSH concentrations in five human tissues sorted by increasing values (from Barp et al., 2014). © Elsevier Ltd
Figure C.3
Figure C.3
HPLC‐GC‐FID chromatograms from the various investigated tissues from the same subject. From Barp et al. (2014). © Elsevier Ltd
Figure C.4
Figure C.4
MOSH in human body (g) sorted by increasing values. © Elsevier Ltd
Figure C.5
Figure C.5
GC × GC‐FID plots of HPLC fractions of the saturated hydrocarbons from four tissues of the same male subject. Concentrations refer to total MOSH determined by HPLC‐GC. Horizonal axes: first dimension chromatography from polar column; vertical axes: second dimension chromatography on non‐polar stationary phase. From Biedermann et al. (2015). © 2014 Elsevier B.V.
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