Registration Dossier

Administrative data

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

Alcohols, C20-30 (even numbered), is a UVCB substance that comprises several linear long chain alcohols, predominantly tetracosan-1-ol (C24), hexacosan-1-ol (C26), and octacosan-1-ol (C28). Together, these substances make up approximately 75% of the composition of Alcohols, C20-30 (even numbered). 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 Alcohols, C20-30 (even numbered), 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 Alcohols, C20-30 (even numbered), has been documented within this dossier. Adequate reliable measured data exists for short-term toxicity to substances that are themselves constituents of as well as analogous to the primary components of the substance. 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 Alcohols, C20-30 (even numbered).

 

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 Alcohols, C20-30 (even numbered), 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 substance Alcohols, C20-30 (even numbered), characterised as comprising long chain alcohols including constituents tetracosan-1-ol, hexacosan-1-ol, and octacosan-1-ol, is of low acute toxicity to aquatic organisms with most LC50’s for aquatic organisms. Algal and daphnid studies, using a QSAR, predict EC50's of greater than the level of solubility for the shortest chain linear alcohol components of Alcohols C22 -30 (even numbered), branched and linear. In addition experimental short-term fish studies (Wetton, 1996 and 2000) determined LC50's of greater than the limit of solubility. As a result, Alcohols, C20-30 (even numbered), 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 Alcohols, C20-30 (even numbered), 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).