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Long-term toxicity to fish

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Description of key information

There are no long-term test data for fish. Testing is not considered necessary because:

  • Short-term toxicity to aquatic organisms is low.
  • The substance is naturally occurring in aquatic organisms.
  • The substance is readily biodegradable, soluble and unlikely to bioaccumulate.

  

In accordance with Column 2 of REACH Annex IX, the requirement for long-term toxicity data for aquatic invertebrates (required in Section 9.1.3) is waived on the grounds that the chemical safety assessment indicates that it is not necessary.

Key value for chemical safety assessment

Additional information

In accordance with Column 2 of REACH Annex IX, the study does not need to be conducted because the registrant has concluded based on the following assessment of the chemical that long-term toxicity to fish is unlikely to be observed:

- citric acid is essential in the Krebs cycle (or TCA cycle), which in turn is an essential chemical cycle that takes place in all living organisms to generate energy, via the generation of adenosine triphosphate (ATP). This means that citric acid is naturally present inside all living organisms and it is very unlikely that it will be found in the environment at concentrations high enough to exert hazards to organisms (see attached report);

- the short-term aquatic toxicity data indicate that citric acid is of low toxicity, with EC50 and LC50 values >100 mg/L for fish and invertebrates and a NOEC of 425 mg/L for algae. In addition, citric acid has been used as a supplement in fish feed to improve growth, mineral bioavailability and feed performance (Shah et al. 2015). Therefore, long-term effects in studies conducted at standard doses are considered to be unlikely;

- the substance is readily biodegradable, has a log Kow <3 and is highly soluble. Therefore, it is very unlikely to persist in the environment long enough to cause long-term effects.

Overall, it is concluded that the risk characterisation conclusion is sufficiently conservative in respect of any uncertainties and therefore further testing is not considered necessary.

Reference:

Shah, Syed Zakir & Afzal, Muhammad & Khan, Shafaat & Hussain, Syed & Zeeshan, Rana. (2015). Prospects of Using Citric Acid as Fish Feed Supplement. International Journal of Agriculture and Biology. 17. 1-8.