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Long-term toxicity to aquatic invertebrates

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Description of key information

In accordance with REACH Annex IX, the requirement for long-term toxicity to invertebrates is waived on the basis that the substance is readily biodegradable and has low toxicity to aquatic life. No reliable predicted or measured long-term toxicity to invertebrates data are available for Alchisor CAL 145 (or Alchisor CAL 123).

Key value for chemical safety assessment

Additional information

Alchisor CAL 145 comprises alkenes C13-14 hydroformylation products and read-across from the chemically-similar Alchisor CAL 123 has been used in this hazard assessment as defined in the `Read-Across Justification Document'. In accordance with Column 2 of REACH Annex IX, the long-term aquatic toxicity to invertebrates study (required in Section 9.1.6) does not need to be conducted for Alchisor CAL 145 as the chemical safety assessment according to Annex I indicates that this is not necessary. Adequate evidence exists for a waiver. It can be concluded in read-across from the chemically-similar Alchisor CAL 123, that it is unlikely that chronic toxicity to invertebrates will be exhibited in the environment following exposure to Alchisor CAL 145 as the substance is readily biodegradable and low toxicity to aquatic life. Therefore, the data requirement for long-term toxicity to invertebrates is waived. Below is a summary of the supporting evidence that Alchisor CAL 145 would be unlikely to cause long-term toxicity to invertebrates based on rapid biodegradation and low acute toxicity. There are no reliable measured or predicted data for chronic invertebrate studies relating to Alchisor CAL 145 (or Alchisor CAL 123).

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 water and be unavailable for long-term uptake by fish.

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. In addition, because the substance has been deemed readily biodegradable, it is unlikely that invertebrates would encounter long-term exposure to the substance. Using this evidence it is assumed that Alchisor CAL 145 represents a low hazard and is not considered to be toxic (in PBT terms) to aquatic life.

In summary, the data requirement for long-term toxicity to invertebrates is being waived based on the evidence that the substance is readily biodegradable and has low toxicity to aquatic life.