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EC number: 939-894-0 | CAS number: -
A full justification for the read across applied for this substance is contained within Section 1.4, reference " Explanation of NovaSpec Base Oil - FINAL". This document contains a full explanation of the manufacturing route for the substance and discussion on why this substance should be considered as a UVCB white oil. Physical properties of the crude reaction product and the different product grades (or distillate fractions) derive from the general chemical structure characteristics (linear-branched alkanes with characteristic branching length and position). Specific unique chemical structures are not isolated in any process step and due to the tens of thousands of isomers and the high degree and variable nature branching and chain length, the base oil bulk properties are the result of the average structure characteristics. The unique viscosity grades each contain all the same typical chemical structures and predominantly overlapping Molecular Weight distributions. The unique viscosity and volatility characteristics of each viscosity grade derive from the boiling point distribution, a result of the short-path distillation (wiped film evaporation). This is identical to the production of petroleum derived white oils.
In order to avoid the requirement to further test a substance that is a derived white oil on animals, a weight of evidence approach is utilised to provide evidence of lack of dermal toxicity. This is via the utilisation of various literature papers.
Conclusions on dermal absorption are based on the results of experiments with hydrocarbon surrogates. Rossmiller and Hoekstra (1966), reported that 48 hr after the application of [14C] hexadecane in mineral oil to the backs of guinea pigs only a very small amount, less than 0.1% of the applied dose, was found in the dermis. Following a single topical application (2.0 g/kg) of chlorinated paraffins to rats, Yang et al. (1987) reported that less than 1% of C18 paraffin and less than 0.1% of C28 paraffin was recovered in faeces, urine, expired air or tissues over 96 hr. In vitro human skin penetration studies with [14C] n-pentadecane and [14C] n-undecane in chlorinated paraffins have reported 0% and less than 0.01% of the applied dose, respectively, in the receptor fluid after 54 hr (Scott, 1989). The results of microscopic studies suggest that the depth of penetration of hydrocarbons such as octadecane is limited to the stratum corneum in mouse (Ghadially et al., 1992) and human skin (Zesch and Bauer, 1985). Collectively, these data support the view that mineral oil does not effectively penetrate the skin beyond the stratum corneum, resulting in minimal (<1%) absorption of white mineral oils after topical exposure.
More recently, the results of studies by Brown et al. (1995), Diembeck and Duesing (1993) and Diembeck and Grimmert (1993) investigating percutaneous absorption of [14C] hexadecane and [3H] docosane from petrolatum or mineral oil after topical application to excised pig skin have confirmed and extended earlier studies. The distribution of the test material between the skin surface, horny layer, epidermis, dermis and receptor fluid was determined. Percutaneous absorption and dermal penetration of [14C] hexadecane and [3H] docosane from petrolatum and Mineral Oil, USP was measured 24 hr after topical application to excised pig skin. Neither radiolabelled compound was measured in the receptor fluid and, in the dermis, 0.8% or less of the total radioactivity was measured 24 hr after application to the skin. These data are further evidence that topically applied mineral hydrocarbons penetrate the skin barrier very slowly and that less than 1% reaches the dermis.
On the basis of these findings and reports of negligible epidermal penetration of topically applied white mineral oils, there is no evidence of any hazard identified for topical exposure to white mineral oils at any dose in multiple species, and only minor deposition may occur in the stratum corneum.. This conclusion is supported by the long and uneventful human use of white mineral oils in drug and non-drug topically applied products.
All available evidence suggests that subchronic or chronic topical exposure to highly refined white mineral oils does not produce gross or histopathological changes in the internal organs or at the site of application in either C3H mice, F344/N rats or New Zealand White rabbits. Similarly, there is no evidence that chronic topical exposure to white mineral oils produces any adverse effects or shortens the lifespan of animals. On the basis of this review of the available literature, it seems unlikely that sufficient amounts of mineral hydrocarbons will be absorbed after topical administration to result in systemic concentrations high enough to cause deposition in the mesenteric lymph nodes and/or liver and thus lead to histiocytosis and granuloma formation. In this regard, following subchronic and chronic topical application there have been no reported effects on any internal organ system attributable to white mineral oils. Considering the long history of use of white mineral oils in topical applied products, the lack of any substantive toxicological findings in rodents and humans suggests the absence of any health risk.
A NOAEL was not reported, as no effects were noted but is proposed to be greater than or equal to 2000 mg/kg/day (the highest dose tested) based on the lack of treatment-related effects.
This study received a Klimisch score of two and is classified as reliable with restriction because it is an acceptable and well-documented literature study report following basic scientific principles.
No classification is applicable.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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