Leucophor 1111X

Bioaccumulation: aquatic / sediment

Description of key information

Log BCF from regression-based method: 0.500 (BCF: 3.162 l/kg wet-wt) 

Key value for chemical safety assessment

BCF (aquatic species):

0.5 dimensionless

Additional information

According to the REACH Regulation, Annex IX, Column 2, the substance does not need to be tested due to the low potential for bioaccumulation (log Kow < 3) and a low potential to cross biological membranes (high molecular weight, high polarity); furthermore direct and indirect exposure of the aquatic compartment is unsuitable.

Literature bioaccumulation studies are available on the analogous substance 04 and 08 and they demonstrated no bioaccumulation in fish. Bluegills (Lepomis machrochirus) was exposed to the test item in dynamic flowthrough tankwater systems, in order to determine at what degree this product accumulate in portions of the fish, which may be consumed by humans. The concentrations tested were 1 mg/l in the case of analogous substance 04 and 0.1 mg/l in the case of analogous substance 08. The exposure period was 70 day for analogous substance 04 and 35 days for analogous substance 08; the elimination phase was from 7 to 14 days for both the analogous.

During the tests, fish and water were periodically sampled and analysed. A further accumulation study using ¹⁴C-labeled analogous substance 08 was performed at concentrations of 0.01 and 0.001 mg/l; exposure phase was of 30 days, while elimination phase of 14 days.

Only sporadic trace concentrations (less than 0.05 mg/kg) of analogous substances 04 and 08 were present in the fish at exposure levels of 0.1 and 1 mg/l. In most instances, no detectable substances were found. The data indicates that there is no tendency for both the substances to be taken up and stored in the fish. In the case of the ¹⁴C-analogous substance 08, at both the concentrations tested, the levels of radioactivity found in the fish were approximately equal to those found in the tankwater throughout study. Furthermore the absence of accumulated radioactivity demonstrated that neither parent compound, nor possible metabolites of the substance are accumulated in fish (Ganz, 1975).

For completeness sake, the estimation of biodegradation using the BCFBAF v3.01^[1] tool was performed for each one of the Leucophor 1111X constituents. The Log BCF (from regression-based method) has been found to be 0.500 (BCF: 3.162 l/kg wet-wt) in all cases.

All the substances used in a read across approach are Stilbene derivatives Fluorescent Whitening Agents salts. They display similar structural and physicochemical properties: all of them exhibit high degree of dissociation in water and very low octanol/water partition coefficients because to a higher affinity with water phase than the octanol one. They are all very soluble in water, due to the presence of sulphonated groups in the molecules; all of them are expected to undergo to the same environmental fate.

The read across approach can be considered as reliable and representative. Further details about the justification for read across approach are given in the report attached to the Section 13 of this dossier.

^[1]BCFBAF v.3.01 is an application contained in the EpiSuite 4.1, the suite of physical/chemical property and environmental fate estimation programs developed by the EPA’s Office of Pollution Prevention Toxics and Syracuse Research Corporation (SRC).