Decene, hydroformylation products

Toxicity to terrestrial arthropods

Description of key information

  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. No reliable measured terrestrial ecotoxicity data are available for Alchisor CAL 111.

Additional information

Alchisor CAL 111 is thetrade name for decene, hydroformylation products, high boiling. As defined in the ‘Read-Across Justification Document’, data provided for the analogue substance Alchisor CAL 123 is representative of Alchisor CAL 111 and suitable for assessment purpose.

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 analogue 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 123.

Exposure to Soils

It is unlikely that soil organisms will be exposed to Alchisor CAL 111 as there is no intended use involving the direct application of Alchisor CAL 111 to soil. In addition, it is unlikely that indirect exposure will occur, via the application of sewage sludge to land, as Alchisor CAL 111 is expected to biodegrade through the sewage treatment process.

Biodegradation

Alchisor CAL 123 has been shown in the reliable (Klimisch 1) 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 123 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 test substance analogue, 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 123 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 123 is not considered to be toxic (in PBT terms) to mammals and it is reasonable to assume that it is unlikely to be hazardous to birds.

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 of the analogue, Alchisor CAL 123.