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Long-term toxicity to fish

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Reference
Endpoint:
adult fish: sub(lethal) effects
Data waiving:
other justification
Justification for data waiving:
other:

Description of key information

The chemical safety assessment according to Annex I of Regulation (EC) No 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish.

Key value for chemical safety assessment

Additional information

There are no long-term fish studies available for Neopentyl glycol dicaprate (CAS No. 27841-06-1). The chemical safety assessment according to Annex I of Regulation (EC) No 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish. Thus, in accordance with Annex IX, column 2, no further long-term toxicity test to fish is proposed.

According to Regulation (EC) No. 1907/2006, Annex IX, Column 2, 9.1.6, long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. The substance is readily biodegradable; according to the Guidance on information requirements and chemical safety assessment, Chapter R.7b, readily biodegradable substances can be expected to undergo rapid and ultimate degradation in most environments, including biological Sewage Treatment Plants (STPs) (ECHA, 2017). Therefore, the release of the substance to the environment after passing through conventional Sewage Treatment Plants (STPs) is expected to be low. Furthermore, the Guidance (Chapter R7.b (ECHA, 2017)) states that once poorly soluble chemicals enter a standard STP, they will be extensively removed in the primary settling tank and fat trap and thus, only limited amounts will get in contact with activated sludge organisms. Nevertheless, once this contact takes place, these substances are expected to be removed from the water column to a significant degree by adsorption to sewage sludge. Thus, discharged concentrations of this substance into the aqueous/sediment compartment are likely to be low. Available short-term studies from structurally related read-across substances for fish, aquatic invertebrates and algae all indicate no potential for aquatic toxicity. Moreover, no chronic effects on invertebrates up to the limit of water solubility were recorded in a long-term toxicity study using structurally related read-across substances. As there was no sign that fish are more sensitive compared to aquatic invertebrates in the available short- and long-term tests, it cannot be expected that a long-term test with fish will generate different results. Thus, based on the above mentioned results, it can be excluded that the target substance Neopentyl glycol dicaprate (CAS No. 27841-06-1) will exhibit chronic toxicity to fish up to the limit of water solubility. Hence due to animal welfare reasons and to avoid unnecessary vertebrate tests, no further long-term test with fish was proposed.

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