Registration Dossier

Environmental fate & pathways

Bioaccumulation: aquatic / sediment

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

ITC 288/S has a low potential for bioaccumulation.

Key value for chemical safety assessment

BCF (aquatic species):
41 dimensionless

Additional information

One reliable key study is available on the assessment of the bioconcentration factor of the test material ITC 288/S in fish (Cyprinus carpio). The method was equivalent to that described in the OECD Guidelines for Testing of Chemicals (1996) No. 305. The test was performed according to the GLP.

The fish were exposed to 5 mg/L (named level 1) and 0.5 mg/L (named level 2) of test substance during 28 days in a flow through system. The nominal concentrations were selected after a preliminary toxicity test toOryzias latipesshowing a 96 -hours LC50 = 623 mg/L. The concentrations of test substance in test water were measured at 1, 6, 13, 20, 23 and 28 days after test initiation. The concentrations of test substance in test fish were measured at 6, 13, 20, 23 and 28 days after test initiation. As 2 peaks were detected with LC-MS analysis of the test substance, the concentration of each peak was described using the test substance concentration without consideration of the constituent ratio. The each peak was named peak 1 (comp. n=1) and peak 2 (comp. n=2) in the elution order.

No abnormality in behavior or appearance was noted during the test.

The measurements of the test substance in test water showed that the test substance was maintained at more than 94% (comp. n=1) and 83% (comp. n=2) of each nominated concentration. The variation of the concentrations of the test substance was within +/- 20% each other.

The analysis of test substance in test fish showed that at day 23 for level 1, in one replicate the concentration was found to be 24.2 µg/g for comp. n=1 and 37.6 µg/g for comp. n=2. For all other measurements, no test substance was detected and the determination limits of 15µg/g (comp. n=1) and 18 µg/g (comp. n=2) were used for the calculation of the BCF values.

In the study, as all BCFs were less than 100, it was considered that a steady-state was reached at 28th day. However, this consideration is not stated in the OECD GL, therefore the steady state assumption should be considered with caution. However, the determination limits of the analytical method are sufficiently low to conclude that the test substance has a low potential for bioaccumulation.

The BCF values calculated on the basis of the results of analysis after 20, 23 and 28 days from the initiation of exposure, are considered as follows:

Level 1 (i.e. 5 mg/L) :       comp. n=1       BCF = 4.9

Level 1 (i.e. 5 mg/L) :       comp. n=2      BCF = 7.6

Level 2 (i.e. 0.5 mg/L) :    comp. n=1       BCF =< 28

Level 2 (i.e. 0.5 mg/L) :     comp. n=2       BCF =< 41

Due to the uncertainties on the steady state and lack of details (e.g. loading rate), this study is considered as reliable with restrictions.