Olefines polymer, oxidized, hydrolyzed, distn. residues, from C20 alcohols manuf.

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

no hazard identified

Marine water

Hazard assessment conclusion:

no hazard identified

STP

Hazard assessment conclusion:

no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:

no hazard identified

Sediment (marine water)

Hazard assessment conclusion:

no exposure of sediment expected

Hazard for air

Air

Hazard assessment conclusion:

no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:

no exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Additional information

Olefines polymer, oxidized, hydrolyzed, distillation residues is a by-product of the C20 alcohols manufacturing process. It is a UVCB substance that comprises several linear long chain alcohols, predominantly docosan-1-ol (C22), tetracosan-1-ol (C24), hexacosan-1-ol (C26) and eicosan-1-ol (C20). Together, these substances make up over 80% of the composition of olefines polymer, oxidized, hydrolyzed, distillation residues. Other constituents include, to a much lesser extent, secondary long chain alcohols and complex mixtures of long chain carboxylate esters. On this basis, study data, where available, for each of the long chain alcohol constituents has been evaluated and considered together; this is consistent with the Category approach applied for Long Chain Alcohols (LCA) under REACH.  In a conservative approach the most sensitive study result from the constituents of the LCA category have been identified and used to address the endpoint in question. The Key study for each endpoint, which is the most sensitive study result from across the main olefines polymer, oxidized, hydrolyzed, distillation residues constituents, is summarised below. There was no reliable toxicity data for aquatic plants therefore a waiver is applied for that endpoint.

The short-term toxicity in fish, invertebrates and algae of components of olefines polymer, oxidized, hydrolyzed, distillation residues has been documented within this dossier. Adequate reliable measured data exists for short-term toxicity to components of the substance (namely, icosan-1-ol and docosan-1-ol). In a conservative approach the most sensitive study result from across these main constituents has been identified and used to address the hazard endpoint in question. The most sensitive study results from across the substances has been identified for each endpoint in which reports of LC50 (or equivalent) are at, or greater than, the limit of solubility (LoS). As the toxicity data are greater than the LoS, this limit is taken as the short-term toxicity endpoint for olefines polymer, oxidized, hydrolyzed, distillation residues.

 

For long-term toxicity, sufficient information is available to predict an absence of toxicity at the limit of solubility for linear alcohols with carbon chain lengths ≥C15. Moreover, from experience gained in tests that have been conducted with substances in this category, considerable technical difficulties would be expected in conducting such a test, due to the low solubility of the test substance and its very rapid biotic removal from the test system. Therefore, long-term toxicity to aquatic organism requirements are waived based on technical testing difficulties, ready biodegradation and low to no short-term toxicity to aquatic organisms at the limit of solubility.

Similarly, the toxicity to microorganisms does not need to be conducted as the substance is readily biodegradable and the applied test concentrations are in the range that can be expected in the influent to a sewage treatment plant. Since the most sensitive study result across the two olefines polymer, oxidized, hydrolyzed, distillation residues constituents was used to represent the toxicity of the test substance, it is deemed that this approach would be protective of the environment.

No terrestrial studies were available for the test substance, the REACH requirement in Annexes IX and X for studies on terrestrial organisms is waived if direct or indirect exposure of the soil compartment is unlikely. In particular, substances that are unlikely to be persistent in the environment do not require long-term terrestrial testing. Terrestrial testing is waived based on the unlikely direct or indirect exposure to soils, technical difficulties associated with conducting studies, the ready biodegradability of the test substance, the low toxicity in aquatic organisms and the low toxicity in mammals resulting in the unlikely direct or indirect exposure of terrestrial organisms to the test substance.

Conclusion on classification

The test substance olefines polymer, oxidized, hydrolyzed, distillation residues, characterised as comprising long chain alcohols of primary constituents icosan-1-ol and docosan-1-ol, is of low acute toxicity to aquatic organisms with most LC50’s for aquatic organisms being reported as greater than 100 or 1000 mg/L. Algal studies, using QSAR, report EC50 of >0.001 and a short-term fish study (Wetton, 1996) has a LC50 of greater than 0.4 mg//L. However, these toxicity values are greater than the limit of solubility (predicted value of 0.0011 mg/L) and olefines polymer, oxidized, hydrolyzed, distillation residues is not considered to show toxic effects to aquatic organisms below its limit of solubility. As a consequence, these findings do not warrant classification of olefines polymer, oxidized, hydrolyzed, distillation residues under the new Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) do not warrant classification under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations (DSD/DPD).