GTL synthetic paraffin oil shows low liver and tissue retention compared to mineral oil

Carrillo, Juan-Carlos; Shen, Hua; Momin, Fayaz; Kral, Olaf; Schnieder, Holger; Kühn, Susanne

doi:10.1016/j.fct.2021.112701

Cited by 5 publications

(5 citation statements)

References 22 publications

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“…The authors concluded that this was consistent with a lack of evidence for formation of epithelioid granulomas in humans. This conclusion is supported by a proposed adverse outcome pathway (AOP) analysis (Carrillo et al., 2021a,b). In humans, liver lesions consisted of accumulation of saturated hydrocarbons and lipoid granulomas of no clinical relevance.…”

Section: Assessmentmentioning

confidence: 99%

“…Carrillo et al. ( 2021a , b ) compared the tissue accumulation and retention of a white mineral oil product (N70H, CAS 8042‐47‐5) with a gas to liquid (GTL) synthetic oil product (CAS 1262661‐88‐0) of similar carbon range distribution. The N70H oil was a medicinal grade naphthenic oil with carbon numbers in the range of n‐C18 to n‐C48 and consisting of approximately 84% naphthenes, 3% linear alkanes, 7% mono/dimethyl alkanes and 4% more branched alkanes, whereas the GTL oil consisted of ∼ 99% iso‐alkanes, with 3% mono/dimethyl alkanes and the rest multibranched iso‐alkanes in the n‐C20 to n‐C42 range.…”

Section: Assessmentmentioning

confidence: 99%

“…This is based on studies described above for SD rats given GTL oil (mainly isoalkanes) and N70H oil (mainly cycloalkanes) by Carrillo et al. ( 2021a , b ) and F344 rats given L‐C25 (virtually free of wax components, containing iso‐and cycloalkanes above n‐C‐25) by Barp et al. ( 2017a , b ).…”

Section: Assessmentmentioning

confidence: 99%

“…In a recent study, Carrillo et al. ( 2021a , b ) compared the tissue accumulation and retention of a naphthenic white mineral oil product with a GTL oil product of similar carbon range distribution (for details, see Section 3.1.1 ). Groups of female SD rats received a diet spiked with 3,000 mg/kg (∼ 200 mg/kg bw per day) of either of the two oils for 134 or 90 days followed by 44 days on a control diet.…”

Section: Assessmentmentioning

confidence: 99%

“…Animal studies from 1980 onwards were screened for evidence on possible MoA for reported spleen effects. Six studies were found for F‐344 rats only (Baldwin et al., 1992 ; Smith et al., 1996 ; Trimmer et al., 2004 ; McKee et al., 2012 ; Barp et al., 2017 a , b ; Cravedi et al., 2017 ; Nygaard et al., 2023 ), three studies comparing F‐344 and SD rats (Firriolo et al., 1995 ; Griffis et al., 2010a , b ; Boogaard et al., 2017 ) and one study on SD rats only (Carrillo et al., 2021a , b ), respectively.…”

Section: Assessmentmentioning

confidence: 99%

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Update of the risk assessment of mineral oil hydrocarbons in food

Schrenk,

Bignami,

Bodin

et al. 2023

EFS2

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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 speciesspecific 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.

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Section: Assessmentmentioning

confidence: 99%

Section: Assessmentmentioning

confidence: 99%