Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

Screening data

Bioconcentration factor (BCF):

When measured BCF values are not available, a BCF may be predicted from the relationship between Pow and BCF. According to ECHA guidance, the most common and simplest QSAR models are based on correlations between BCF and chemical hydrophobicity (as modelled by logPow). The mechanistic basis for this relationship is the analogy of the partitioning process between lipid-rich tissues and water to that between n-octanol and water (whereby n-octanol acts as a lipid surrogate). In this model, uptake is considered to be a result of passive diffusion through gill membranes.

According to an experimental study (OECD 107/ EEC A.8; Bayer AG, Leverkusen, Germany), the logPow was determined as follows: < - 2.4

1.1 EPIWIN© Bioaccumulation estimates (BCFBAF v3.01)

The BCFBAF program estimates BCFs using the Kow (Meylanet al.1999). Data from a wide range of chemical classes (i.e., 466 non-ionic and 61 ionic substances) were used to calibrate the BCFBAF model used by EPIWIN©. For Log Kow < 1.0 a logBCF of 0.5 (3.2L/kg ww) can safely be assumed.


Biomagnification factor (BMF):

No experimental data are available. According to ECHA guidance,the availability of measured BMF data on predatory organisms is very limited at present and so the provided default values should be used as a screening approach designed to identify substances for which it may be necessary to obtain more detailed information. Accordingly, the default BMF value is 1 (BCFfish< 2,000) for organic substances with a logPow < 4.5. Therefore, biomagnification appears to be low.


Summary and discussion of bioaccumulation

According to ECHA “Guidance on information requirements and chemical safety assessment / Part C: PBT assessment” (May 2008), the criteria for bioaccumulation (B and vB) are not fulfilled, if the logPow is ≤ 4.5.

For organic substances with a log Kow value below 4.5 it is assumed that the affinity for the lipids of an organism is insufficient to exceed the B criterion, i.e. a BCF value of 2000 L/kg ww.

Furthermore, there is no convincing evidence that Neo Heliopan® AP can biomagnify in the food chain (BMF < 1). Therefore, the criteria for “bioaccumulating” and for “very bioaccumulating” are not fulfilled.