Alkenes, C13-14, hydroformylation products, distn. residues

Endpoint summary

Additional information

Alchisor CAL 145 comprises alkenes C13-14 hydroformylation products with read-across from the chemically-similar Alchisor CAL 123 as defined in the `Read-Across Justification Document'. Where environmental toxicity data exist for Alchisor CAL 123, these are representative of the Alchisor CAL 145 substance. In accordance with REACH Annex IX, the requirement for studies of the effects on terrestrial organisms is waived on the basis of unlikely direct and indirect exposure of the soil compartment. In addition, other evidence presented in this dossier on the substance's ready biodegradability, low toxicity to aquatic organisms and the absence of toxicity to mammals further support the waiver. No reliable measured terrestrial ecotoxicity data are available for Alchisor CAL 145.

Exposure to Soils

It is unlikely that soil organisms will be exposed to Alchisor CAL 145 as there is no intended use involving the direct application of Alchisor CAL 145 to soil. In addition, it is unlikely that indirect exposure will occur, via the application of sewage sludge to land, as Alchisor CAL 145 is expected to biodegrade through the sewage treatment process.

Biodegradation

The chemically-similar Alchisor CAL 123 has been shown in the reliable (Klimisch 1; Klimisch 2 when used for read-across) study by Schaefer and Matthews (2010) to be readily biodegradable in water. The test substance biodegraded to an extent of 87.7% after 28 days and although the biodegradation rate just missed the 10-day window threshold, this aspect of the test is not applicable to mixtures where different components of the mixture can biodegrade preferentially (reference TG 103C). It is assumed that Alchisor CAL 145 will readily biodegrade in the environment and sewage treatment processes and be unavailable for uptake by soil organisms.

Toxicity to Aquatic Organisms

The toxicity of the chemically-similar Alchisor CAL 123 to aquatic organisms is very low based on the evidence presented in this dossier. The lowest measured toxicity was based on an algal test where the NOEL based on algal growth was 25 mg/L. Acute toxicity to invertebrates and fish was >100 mg/L based on 50% mortality. It is reasonable to assume that Alchisor CAL 145 will also exhibit similar toxicities to soil organisms resulting in a low hazard, which is not considered to be toxic (in PBT terms) to terrestrial life.

Toxicity to Mammals

Alchisor CAL 123 is not considered to be toxic to mammals based on the evidence presented in this dossier. Acute oral and acute dermal toxicities in rat were > 2000 and >2020 mg/kg, respectively based on the study by Kuhn (2010). Using this evidence it is assumed that Alchisor CAL 145 is not considered to be toxic (in PBT terms) to mammals and secondary poisoning is unlikely to occur in the environment.

In summary, the data requirement for terrestrial ecotoxicity testing is waived on the evidence of lack of direct or indirect exposure to soil organisms, ready biodegradability in the environment and the absence of toxicity in aquatic organisms and mammals.