1,2-Cyclohexanedicarboxylic Acid, 1-(phenylmethyl) ester, ester with 2,2,4-trimethyl, 1,3-petanediol mono(2-methyl propanoate)

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 evidence suggests that exposure of structural analogue Sancticizer® 278 to water dwelling organisms is expected to be minimal and chronic exposure unlikely. Any acute effects in aquatic organisms that have been detected, occur at concentrations in excess of the water solubility limit and no effects at the limit of water solubility have been detected in chronic tests. It is therefore unlikely that measurable effects are going to occur in a chronic fish test. A chronic fish study is unlikely to offer any further information on the toxicity of Sancticizer® 278 to organisms in the aquatic environment and therefore this endpoint has been adapted in favour of animal protection.

The measurable effects on soil microorganisms indicate that further data on effects on soil dwelling organisms are required for the environmental assessment. To support the terrestrial environmental assessment an OECD 222 and OECD 208 study have been conducted.

Further justification is provided in Section 13 'Chronic Fish Endpoint Adaptation and Testing Strategy.'

Additional information

This endpoint has been adapted based on the following information and for the purposes of reducing testing on vertebrates:

• Three acute and two chronic aquatic toxicity tests have shown no toxicity up to the limit of water solubility. Therefore, exposure in the natural environment is not expected to cause adverse effects.
• The substance has a very low water solubility and high log Kow and so the substance is likely to partition to the soil and sediment in the environment. It is unlikely that the water compartment will be a cause for concern and concentrations will be very low. This is supported by fugacity modelling performed in the EPISUITE model.
• The substance is readily biodegradable and therefore chronic exposures in the (aquatic) environment are not expected to occur.
• Organisms in the soil are more likely to be exposed to this substance at higher concentrations as it is expected to partition to soil and sediment. As such, tests on soil dwelling organisms will provide more meaningful data compared to a chronic fish study. Corresponding studies had either been performed or were commissioned.

Further justification is provided in Section 13 'Chronic Fish Endpoint Adaptation and Testing Strategy.'