For P70(H) oil, the NOEL was based on an increased incidence of pigmented macrophages in male rats at a dietary concentration of 2%, a minor effect considered of doubtful biological significance. class II and III medium- and low-viscosity oils and low-melting-point wax) were based on an increased incidence of histiocytosis in the lymph nodes at the next highest dose. The NOELs for all the other materials except P70(H) oil (i.e. The ADI of 0–20 mg/kg bw for mineral oils with the specifications of high-viscosity oils and of high-melting-point and high-sulfur waxes was based on NOELs at the highest dose tested (2% in the diet) in 90-day studies in Fischer 344 rats. The types of effects seen were similar and included focal histiocytosis, increased weights of liver, lymph nodes, spleen and kidneys, granulomas or microgranulomas of the liver, haematological changes typical of a mild, chronic inflammatory reaction and biochemical changes indicative of mild hepatic damage. Except for P70(H) and P100(H) oils, there was evidence of accumulation of the mineral hydrocarbons and effects indicative of a reaction to a foreign body at one or more doses. All the substances, with the exception of the microcrystalline waxes, appeared to accumulate in the tissues of the animals to varying degrees, depending on the material and dose. The materials tested included low-, medium- and high-viscosity mineral oils (N10(A), N15(H), P15(H), N70(A), N70(H), P70(H) and P100(H)) paraffin waxes (low-melting-point wax and intermediate-melting-point wax) and microcrystalline waxes (high-melting-point wax and high-sulfur wax). Temporary group ADI, extended at the present meetingįood-grade mineral oils were last evaluated by the Committee at its forty-fourth meeting (Annex 1, reference 116), when four 90-day studies conducted in Fischer 344 rats with a range of mineral oils and waxes representative of materials in commercial use were reviewed. N15(H) oil, crude: naphthenic, viscosity (40 ☌): 15 mm 2/s, hydrotreated (catalytic hydrogenation)Įstablished by the Committee at its forty-fourth meeting P15(H) oil, crude: paraffinic, viscosity (40 ☌): 15 mm 2/s, hydrotreated (catalytic hydrogenation N70(H) oil, crude: naphthenic, viscosity (40 ☌): 70 mm 2/s, hydrotreated (catalytic hydrogenation P70(H) oil, crude: paraffinic, viscosity (40 ☌): 70 mm 2/s, hydrotreated (catalytic hydrogenation) P70 oil, crude: paraffinic, viscosity (40 ☌): 70 mm 2/s P100 oil, crude: paraffinic, viscosity (40 ☌): 100 mm 2/s For the purpose of characterization of the different types of oils and waxes, the criteria viscosity, average relative molecular mass and carbon number at 5% distillation-point were used in the specifications (see Table 1). The latter group was furthermore divided into three classes. In order to define the materials more clearly, the Committee at its forty-fourth meeting (Annex 1, reference 116) prepared individual specifications for micro-crystalline wax and for two groups of mineral oils: mineral oils (high-viscosity) and mineral oils (medium- and low-viscosity). Mineral oils (medium- and low-viscosity) are mixtures of highly refined paraffinic and naphthenic liquid hydrocarbons with boiling-points greater than 200 ☌. They are manufactured from crude mineral oils in various refining steps, such as distillation, extraction and crystallization, and are subsequently purified by acid treatment (oleum method) and/or hydrotreatment (catalytic hydrogenation). Mineral oils (medium- and low-viscosity) comprise a subgroup of the family of mineral oils and waxes. Intake due to migration from coating and packaging materials Long-term studies of toxicity and carcinogenicityĬontribution from added mineral hydrocarbons and naturally occurring hydrocarbons Mineral Oils (Medium- and Low-Viscosity) and Paraffin Waxes (JECFA Food Additives Series) WHO FOOD ADDITIVES SERIES: 50 MINERAL OILS (MEDIUM- AND LOW-VISCOSITY) AND PARAFFIN WAXESĬhinese Centers for Disease Control and Prevention, Beijing, China

Lilac mineral oil viscosity