Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 295-458-3
CAS number: 92045-76-6
A complex combination of hydrocarbons obtained from residual oils by solvent crystallisation and treated with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C25.
Discussion on methodology
In undertaking environmental risk assessments the best use of all available ecotoxicity data should be made. However, the assessment of ecotoxicity data for many petroleumproducts is complicated since several different test methods and procedures have been used. As petroleum products contain a mixture of substances with a range of solubilities a critical aspect with respect to interpreting the validity of ecotoxicity tests is how the test media is prepared. Although not always explicitly stated most of the data generated in the period up to the early 1990s originated from experiments in which a "water soluble fraction" (WSF) was tested. WSFs are prepared by mixing the petroleum product with the aqueous test medium (e. g. 25 to 50 mL product with 1 L of medium). After mixing the test solutions are then allowed to stand, the aqueous phase is separated and dilutions of this medium are used in testing the species under study. The results areexpressed either as (a) the dilution, or % WSF, or (b) the concentration of dissolved hydrocarbons expressed in mg/L (CONCAWE, 1992). A disadvantage with these WSF studies is that it is not possible to convert the quoted result to the amount of product that must be added to a given volume of aqueous medium to produce the effect.
The problems of preparing test media for oil products were recognised in the early 1990s. As a consequence the recommended method, which enables ecotoxicity assessments of petroleum products to be interpreted, was to determine the amount of test substance that must be equilibrated with the test medium to produce a specified level of effect. This is the so-called "loading rate" or Water Accommodated Fraction (WAF) methodology as developed by Girling et al. (1992) and reported in CONCAWE (1992). Even with these laboratory based studies there are doubts about their value in the context of risk assessment owing to the fact that once a petroleum product is released to the environment its constituent substances will partition to the various compartments (water, sediment, soil and air) in accordance with their physico-chemical properties. The assumption being that in the receiving environment the substances will be degraded and transformed in accordance with their individual susceptibilities to physical, chemical and biological degradation processes and will exhibit effects in accordance with their individual toxic potencies.
Discussion on mechanisms of toxicity and PNEC derivation
In an attempt to better understand the potential for adverse effects of a product, the effects of a product's constituent substances (hydrocarbon blocks) can be integrated in such a way that an overall assessment of their combined effects can be made. For the assessment of toxic effects it is important that the method of integration meets the assertion that effects can only be integrated for substances that share the same mode of toxic action. All components of petroleum products exhibit non-polar narcosis effects on organisms.
Under ideal circumstances a PNEC for a hydrocarbon block would be derived from ecotoxicological test data for one or more components that are representative of that block. The TGD sets out how this can be done either by applying an Assessment Factor to the lowest acute ecotoxicological effect or chronic no effect concentration or by applying statistical extrapolation methods to a number of data points. For petroleum products this was not a practical option since the majority of its mass is comprised of chemical components that cannot be accurately described by a chemical structure (and which may not have a unique CAS number) and for which there is an absence of ecotoxicological data. Under such circumstances the only practical option is to estimate a PNEC using a relationship between physico-chemical descriptors of a component or a hydrocarbon block and concentrations resulting in ecotoxicological effects or absence of an effect. This is the hypothesis encompassed by the Target Lipid Model (TLM) described by McCarthy et al. (1991).
The theory underpinning the TLM is that the concentration of a substance in a lipid that is responsible for the onset of a non-polar narcosis effect is the same when expressed on a molar basis for a range of taxonomic groups e. g. fish, invertebrates and algae. Consequently the toxic potency of a substance depends upon its capacity to achieve the threshold concentration within an organism. There are a number of variables that determine this capacity, key of which are the solubility of the substance in water and lipid and its molecular size. In an application of the theory, DiToro et al. (2000) have published a non-polar narcosis-based QSAR for predicting the aqueous concentration of a hydrocarbon substance that induces a specified level of biological effect. The QSAR relates biological effect to the log Kow of the substance. Log Kow is a function of the solubility of a substance in water and lipid (octanol) but is limited by molecular size because large molecules cannot pass through biological membranes.
In the absence of measured ecotoxicity data for a substance the TLM and associated QSARs provide a theoretical basis for predicting the ecotoxicity of a substance. By extension of the theory it should also be possible to evaluate the toxicity of a mixture of substances provided that they have the same mode of toxic action. McGrath et al. (2004) have validated the theory by characterising the aquatic toxicity of six gasoline blending streams and have showed that predicted and measured toxicity were in good agreement.
Having established procedures that enable the toxicity of a mixture of hydrocarbons to be predicted, McGrath et al. (2004) have also utilised statistical theory developed by a number of workers to define an acute species sensitivity distribution for narcotic chemicals. A relationship has been established enabling the concentration of a hydrocarbon substance to be determined that will affect a specified proportion of the species present in a community. By setting the proportion to a notional low level (e. g. 5%), a hazard concentration (HCx where x is the proportion that might be affected i. e. 5%) is obtained. The HCx has similarities with a hazard concentration derived by applying statistical extrapolation procedures described in the TGD to a set of test substance data. It can also be considered analogous to, and used for risk assessment in the same way as, a PNEC derived by applying an Assessment Factor (AF) specified in the TGD to a lowest acute EC50 or LC50 value in a data set.
Read across justification
Several criteria justify the use of the read across approach to fill data gaps for paraffin and hydrocarbon waxes using other lubricant base oil analogs. Primarily the basis for the read-across is the similar physical chemical properties shared by the paraffin and hydrocarbon waxes and other lubricant base oils. Other lubricant base oils are not highly soluble in water, therefore for aquatic toxicity tests; the Water-Accommodated Fraction (WAF) is used in the toxicity testing. The WAF is created by prolonged (usually 24 hours) water and oil mixing. Then it is allowed to settle and this aqueous phase is used in the toxicity tests. This aqueous phase may contain dissolved, emulsified, or dispersed other lubricant base oil.
Short- term toxicity to fish, short- and long- term toxicity to aquatic invertebrates, toxicity to aquatic algae and cyanobacteria, and toxicity to microorganisms have been filled by read-across of measured data from the other lubricant base oils category. They are supported in a weight of evidence approach by a calculated value using composition information derived from two dimensional gas chromatography in conjunction with the PETROTOX model.
Short-term toxicity to fish:
In a read-across key static 96-hour short-term fathead minnow (Pimephales promelas) limit test (OECD 203; KS=1), 10 animals/loading were exposed to the WAF of an other lubricant base oil, Basestock Solvent Neutral 600 (MRD-94 -981) at a nominal concentration of 100 mg/L. The LL50 was > 100 mg/L and the NOEL was ≥100 mg/L (Exxon, 1995b).
Supporting data estimated from the PETROTOX computer model show no acute toxicity of paraffin and hydrocarbon wax to freshwater fish at or below its maximum attainable water solubility (Redman et al., 2010b). These data support the applied read across.
Long-term toxicity to fish:
The long-term toxicity for fish endpoint is addressed by read across to long-term toxicity for aquatic invertebrates (Daphnia magna). Read across to OLBOs has been applied for the long-term toxicity to aquatic invertebrates endpoint, which is justified based on similarities in composition and physical/chemical properties between paraffin and hydrocarbon waxes and OLBOs. Toxic effects of hydrocarbons are primarily caused by narcosis, and occur in a narrow range of molar concentrations across aquatic taxa; hence, read across between species is justified.
Results of computer modelling to estimate aquatic chronic toxicity in a 28-day freshwater fish study show no chronic toxicity of paraffin and hydrocarbon wax to freshwater fish at or below its maximum attainable water solubility (Redman et al., 2010b). This supports the applied interspecies read across.
Short-term toxicity to aquatic invertebrates:
In a read-across key static 48-hour short-term Daphnia magna toxicity test (OECD 202; KS = 2), 10 animals/loading were exposed to the WAF of an other lubricant base oil, MVI(N) 40 base oil (CAS # 64742-53-6 or 64741-97-5), at nominal concentrations of 0, 10, 100, 1000, and 10,000 mg/L. The EL50 was >10,000 mg/L and the NOEL was ≥ 1000 mg/L (Shell, 1988).
In a read-across key semi-static 96-hour short-term freshwater shrimp (Gammarus pulex) toxicity test (OECD 202; KS = 2) to other lubricant base oils, 10 animals/loading were exposed to the WAF of an other lubricant base oil, MVI(N) 40 base oil (CAS # 64742-53-6 or 64741-97-5), at nominal concentrations 0, 10, 100, 1000, and 10,000 mg/L. The LL50 was >10,000 mg/L and the NOEL was ≥ 10,000 mg/L (Shell, 1988).
Supporting data estimated from the PETROTOX computer model show no acute toxicity of paraffin and hydrocarbon waxes to freshwater fish at or below its maximum attainable water solubility (Redman et al., 2010b). These data support the applied read across.
Long-term toxicity to aquatic invertebrates:
In a read-across key semi-static 21-day long-term Daphnia magna toxicity test (OECD 211; KS = 2), 10 animals/loading were exposed to the WAF of other lubricant base oil LVIN 38 (CAS #64742-53-6) at nominal concentrations of 1, 10, 100 and 1000 mg/L. The NOEL was 10 mg/L based on reproduction. The loss of all daphnids in the 100 mg/L WAF was attributed to a non-treatment related effect, the cause of which was unknown. Further testing would be required to clarify the consequences of exposure to a 100 mg/L WAF of the base oil (Shell, 1995).
Supporting data estimated from the PETROTOX computer model show no acute toxicity of paraffin and hydrocarbon wax to freshwater invertebrates at or below its maximum attainable water solubility (Redman et al., 2010b). These data support the applied read across.
Toxicity to aquatic algae:
In a read-across key static 72-hour algal (Pseudokirchneriella subcapitata) limit test (OECD 201; KS = 2), the freshwater alga was exposed to the WAF of an other lubricant base oil (N100DW), at a nominal concentration of 100 mg/L. The NOEL was ≥ 100 mg/L based upon average specific growth rate and cell yield (Petro-Canada, 2008).
Supporting data estimated from the PETROTOX computer model show no acute toxicity of paraffin and hydrocarbon wax to algae at or below its maximum attainable water solubility (Redman et al. 2010b). These data support the applied read across.
Toxicity to microorganisms:
In a read-across key static 4-day Photobacterium phosphoreum luminescence inhibition study (KS=2) using other lubricant base oils as control substances, no significant luminescence inhibition was observed for Spindle oil (BP 320-400 ºC) and Neutral oil Ro NIII (BP 400-450 ºC), as well as for the n-paraffin dodecane. The NOEL for Spindle oil was > 1.93 mg/L and the NOEL for Neutral oil Ro NIII was > 2.17 mg/L (Riis et al., 1996).
Results of computer modelling to estimate aquatic toxicity show no acute toxicity of paraffin and hydrocarbon wax to aquatic microorganisms at or below its maximum attainable water solubility (Redman et al., 2010b). This supports the Riis et al. 1996 experimental results mentioned in the previous paragraph.
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.
Sellel veebilehel kasutatakse küpsiseid, et tagada lehe parim kasutus.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again