[No public or meaningful name is available]

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

fish early-life stage toxicity

Data waiving:

study scientifically not necessary / other information available

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.

Additional information

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 release of the substance to the environment after passing through conventional Sewage Treatment Plants (STPs) is expected to be low. The Guidance on information requirements and chemical safety assessment, 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 (Guidance on information requirements and chemical safety assessment, Chapter R.7a, (ECHA, 2017). Thus, discharged concentrations of Fatty acids, C16-18 (even numbered), esters with glycerol oligomers into the aqueous/sediment compartment are likely to be low.

Furthermore, the acute fish test showed no mortality or sub-lethal effects after 96 hours of exposure. The reports evaluating the acute toxicity of the target substance to Daphnia magna reported no effects after 48 h (EC50 (48 h) of > 0.08 mg/L, measured geom. mean).In addition, for chronic toxicity of a structurally related substance to Daphnia magna no effects up to the limit of water solubility were determined (NOELR (21d) ≥ 10 mg/L (nominal)). The studies conducted with algae for the target and the source substance concluded that the target substance is not expected to show toxicity to algae up to the limit of its water solubility (91.9 µg/L). Furthermore, one study with Lemna gibba for the target substance observed no inhibition after 7 days for the tested concentration (EL50 (7d) of > 100 mg/L (nominal), NOEC (7 d) of ≥ 100 mg/L (nominal)). The observed effects for all trophic levels are well above the water solubility of the substance (91.9 µg/L). 

Based on the short-term values, fish cannot be identified as the most sensitive organism. According to the Guidance on information requirements and chemical safety assessment Chapter R.7b: Endpoint specific guidance, R.7.8.5.3 (ECHA, 2017), long-term testing with fish should only be conducted if it represents the most sensitive taxonomic group.Thus and for reasons of animal welfare, long-term testing on fish is not proposed.