Fatty alcohols, C12-18 (even numbered), manuf. of, destn. residues

Sediment toxicity

Description of key information

In accordance with the Regulation (EC) No 1907/2006 REACH concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, determination of sediment toxicity is not a mandatory information requirement under Annex IX.

Additional information

The data requirement for sediment studies is waived as it is not mandatory for Annex IX. Furthermore, this endpoint can be waived if long-term toxic effects to sediment organisms are unlikely. Testing for sediment organisms is waived based on technical testing difficulties associated with conducting studies, the lack of evidence for persistence and the absence of toxicity in aquatic organisms as presented in more detail below:

Study not technically feasible

The requirement to conduct bioaccumulation studies for alcohol C18-22, distillation residues is waived due to the technical difficulties in performing such a test. The water solubility of the substance is below <1 mg/L.The low solubility of the substance means that it is technically unfeasible to undertake a guideline (standard) study of bioaccumulation in fish where the test substance would need to be maintained in solution for 56 days to be available for uptake by fish.

Persistence

Results of the ready biodegradability tests with Behenyl Bottoms, which are used in a read-across approach in the registration of Alcohols, C12 -18, distn.residues, demonstrate that it is inherently biodegradable in fresh water (Schaefer & Matthews, 2010). The test substance biodegraded to an extent of 84.1% after 60 days and can be regarded as inherently biodegradable. According to ECHA Guidance, when the half-life is greater than 40 days in freshwater, the substance is considered to be persistent. Based on an average of three replicates and the steady rate of biodegradation, it can be assumed that the half-life of the substance is below the persistence (P) criterion when 50.3% of the substance biodegraded in a freshwater environment by day 37 of the test (Schaefer & Matthews, 2010). In accordance with ECHA Guidance (Chapter R.11, PBT Assessment), Behenyl Bottoms does not fulfil the PBT or vPvB criteria for Persistence (P) and is considered to be unavailable for uptake by sediment organisms.

The result is used in a read-across approach in the REACH Registration of Alcohols, C12 -18, distn. residues.

Toxicity to Aquatic Organisms

Results of Behenyl Bottoms (alcohol C18-C22 distillation residues) are used in a read-across approach in the REACH registration of Alcohols, C12 -18, distn. residues.

Generally the short-term aquatic toxicity of Behenyl Bottoms (alcohol C18-C22 distillation residues) is low based on experimental evidence presented in this dossier. The short-term toxicity of Behenyl Bottoms to invertebrates and fish was reported by Palmer et al., (2009) in OECD guideline and GLP compliant studies resulting in LC50’s of >100 mg/L. In addition, long-term toxicity is considered to be below the limit of solubility (LoS) for alcohols > C15 in chain length based on evidence presented in the Long Chain Alcohols SIDS report (2006). It is unlikely that the substance would be available for uptake from the aquatic compartment. Therefore, long-term toxicity to sediment organisms is waived based on technical testing difficulties due to low solubility of the test substance and the absence of short-term toxicity to aquatic organisms at the limit of solubility. In summary, the data requirement for studies for sediment organisms is waived on the evidence of testing technical difficulties, lack of persistence in the environment and the absence of toxicity in aquatic organisms.