Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
Only few experimental data on toxicokinetic are available for GTL substances. To support the evaluation of the toxicokinetic profile of the registration substances, complementary experimental toxicological data of petroleum-derived hydrocarbons of similar structures and chain lengths in the relevant range are used. Additionally, a qualitative judgement on the toxicokinetic behaviour based on physico-chemical characteristics is done.
Absorption
Absorption through the gastro-intestinal tract is the most relevant exposure route. Generally, oral absorption of alkanes decreases with increasing carbon chain length. It was shown that constituents with a carbon number of above C32-C35 are not absorbed to a significant extent (Freeman et al., 1993). Due to the high carbon number constituents of the registration substance (~C25-150), it is expected that only a minor proportion of components in the lower carbon number range of the registration substance can be potentially orally absorbed.
Dermal absorption and absorption via inhalation are negligible for registration substances for the following reasons: the registration substance is a waxy solid, highly viscous, and hydrophobic with a low vapour pressure (< 1 Pa). The current regulatory consensus is that hydrocarbons with carbon chain lengths of >C20 are not considered systemically available via the cutaneous exposure route (Petry et al., 2017). For the registration substance with carbon numbers of C25 and above, dermal exposure is not considered relevant.
Distribution and accumulation
If absobed, based on physico-chemical parameter, the registration substance is not expected to be distributed extensively due to the low water solubility. The substance is likely to distribute into the cells and the intracellular concentration may be higher than extracellular concentration particularly in fatty tissues. The substances do indicate a significant potential for accumulation based on the high LogKow (ECHA Guidance R. 7c, ECHA 2017c).
Metabolism and excretion
Absorbed fractions, consisting of normal, iso- and cycloalkanes undergo hepatic elimination by different alkyl chain oxidation pathways. Depending on the water solubility of the alcohols created by metabolism via CYP enzymes, metabolites of alkanes are either excreted via urine, further metabolised and degraded followed by excretion of the fragments via the urine if appropriate water solubility is achieved or ultimately degraded to CO2, or incorporated into standard cellular structures.
For more information on toxicokinetic, please refer to the read-across statement attached in section 13.
References:
Freeman, J., Simpson, B.J., Tietze, P., White oil and waxes – summary of 90-day studies, CONCAWE Report 93/56, CONCAWE, Brussels, 1993
Petry, T., Bury, D., Fautz, R., Hauser, M., Huber, B., Markowetz, A., ... & Teichert, T. (2017). Review of data on the dermal penetration of mineral oils and waxes used in cosmetic applications. Toxicology letters, 280, 70-78.
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.
