Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

Vegeflux Soy is a UVCB. Standard tests for this endpoint are intended for single substances and are not appropriate for this complex substance.

At the base-set level, the potential for bioaccumulation can be estimated from the value of the n-octanol/water partition coefficient, log Kow. It is accepted that values of log Kow greater than or equal to 3 indicate that the substance may bioaccumulate. As the log Kow of Vegeflux Soy is estimated to be higher than 6.5, it can be estimated that this substance may biaccumulate to a significant degree.

There are, however, a number of factors that are not taken into consideration when BCF is estimated only on the basis of log Kow values:

- Adsorption: adsorption onto biological surfaces, such as gills or skin, may also lead to bioaccumulation and an uptake via the food chain. Hence, high adsorptive properties may indicate a potential for both bioaccumulation and biomagnification.

Vegeflux Soy is considered as immobile in soils and as adsorbed to suspended solids and sediment in water based upon estimated Koc of its main constituents.

- Hydrolysis: the effect of hydrolysis may be a significant factor for substances discharged mainly to the aquatic environment: the concentration of a substance in water is reduced by hydrolysis so the extent of bioconcentration in aquatic organisms would also be reduced.

Hydrolysis is not expected to be an important degradation process of Vegeflux Soy in the environment due to a very low water solubility.

- Degradation: both biotic and abiotic degradation may lead to relatively low concentrations of a substance in the aquatic environment and thus to low concentrations in aquatic organisms. However, the uptake rate may still be greater than the rate of the degradation processes, leading to high BCF values even for readily biodegradable substances. Therefore ready biodegradability does not preclude a bioaccumulation potential, but for most substances concentrations will be low in aquatic organisms.

As Vegeflux Soy is considered as readily or rapidly biodegradable, it suggests that biodegradation may be an important environmental fate process.

- Molecular mass: certain classes of substances with a molecular mass greater than 700 are not readily taken up by fish, because of possible steric hindrance at passage of gill membranes or cell membranes of respiratory organs. These substances are unlikely to bioaccumulate significantly (regardless of the log Kow-value). However it is not the case for Vegeflux Soy.

- Metabolism: fatty acids occurs naturally in animal, fish and vegetable fats. Fatty acids are widely distributed in nature as components of animal and vegetable fats and are an important part of the normal daily diet of mammals, birds and invertebrates.

If taken up by fish, these carboxylate ester-containing substances are expected to be readily metabolized and excreted.

Fatty acids, stored as triglycerides in an organism, are an important source of energy for many cellular organisms. All cell membranes are built up of phospholipids, each of which contains two fatty acids. Fatty acids are also used for protein modification.

Thus Vegeflux Soy will probably be readily metabolised and excreted, reducing the potential of bioaccumulation.

- Potential to cause toxic effects if accumulated in higher organisms: the assessment is based on classifications on the basis of mammalian toxicity data, i.e. the classification as Specific Target Organ Toxicity after repeated exposure (STOT RE category 1 or 2), as toxic for reproduction (category 1A, 1B, or 2) according to Regulation EC No 1272/2008. Here it is assumed that the available mammalian toxicity data can give an indication on the possible risks of the chemical to higher organisms in the environment. If a substance is classified accordingly or if there are other indications (e.g. endocrine disruption), an assessment of secondary poisoning is performed.

Vegeflux Soy is not classified as STOT RE or Repr. Cat. 1A/1B/2.

Calculation of BCF of main constituents with BCFBAF v3.01:

- Methyl linoleate: BCF = 620 L/kg wet wt

- Methyl elaidate: BCF = 2030 L/kg wet-wt

- Linoleic acid: BCF = 56.2 L/kg wet-wt

Thus, the bioaccumulation potential is expected to be much lower than predicted from log Kow alone, and probably not fulfilling the criteria of Annex XIII of REACH.