Registration Dossier

Environmental fate & pathways

Bioaccumulation: aquatic / sediment

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

Component A (the major component of Y-513) has been tested. Component B where one methyl group located in the ortho position in the benzene ring is replaced by a sulphonate group in the para position, is present both as a calcium salt and an aluminium salt. Components C and D each lack, compared to Component B, one of the two methyl carbonyl groups. Considering the large molecular size of this molecule, the structural differences of component B, C and D relative to Component A are not considered to result in a significant different bioaccumulative potential. T, therefore an estimation of the bioaccumulation potential can be made based on the available study with Component A:
BCF at 1.0 mg/L: ≤ 0.5 L/kg
BCF at 0.1 mg/L: ≤ 5 L/kg
Based on these results, Y-513 is considered to have no potential for bioaccumulation.

Key value for chemical safety assessment

Additional information

The bioaccumulation of Component A (the major component of Y-513) in fish was determined under flow-through conditions in a study carried out according to the Japanese guideline "Test of Concentration Level of Chemical Substances in Fish and Shellfish“ regulated in "Methods of Testing New Chemical Substances“ (Notifications of Kanpogyo No. 5 Yakuhatsu No. 615 and Kikyaku No. 49 (392) dated July 13, 1974,as well as OECD305C (1981) and GLP.

Test substance and crystal sugar in an amount of 20-fold as much as the test substance were ground. Subsequently, HCO-40 in an amount of 50-fold as much as the test substance was added and ground. Then polyvinyl alcohol (degree of polymerization: approx. 500) in the same amount as the test substance was added and the mixture was dissolved in deionized water to prepare a 2000 mg/L stock dispersion.

This stock dispersion was aliquoted and diluted with ion exchanged water to 320 mg/L and 32 mg/L in the glass tank of dosing dispersion for the 1.0 mg/L and 0.1 mg/L test concentrations, respectively.

Per test concentration 12 fish were exposed in a 100L test vessel.

Water samples were taken twice a week. From each test concentration two fish were taken for analysis at t = 2, 3, 4 and 6 weeks, From the control, two fish were extracted and analysed by a HPLC-UV method

The measured concentration in water was ≥85% of the nominal concentration.

The measured concentration in fish was below the LOQ of 0.42 µg/g (assuming a fish weight of 30 g). Therefore the BCF values were calculated based on LOQ:

 

BCF at 1.0 mg/L:≤ 0.5 L/kg

BCF at 0.1 mg/L:≤ 5 L/kg

 

Y-513 consists of four major components (component A, B, C and D). Component A is the major component of Y-513. The other components (B, C and D) are the analogues of component A. Component B where one methyl group located in the ortho position in the benzene ring is replaced by a sulphonate group in the para position, is present both as a calcium salt and an aluminium salt. Components C and D each lack, compared to Component B, one of the two methyl carbonyl groups. Considering the large molecular size of this molecule, the structural differences of Component B, C and D relative to Component A are not considered to result in a significant different bioaccumulative potential. 

The National Institute of Technology and Evaluation (NITE), Japan has performed bioaccumulation studies on Component A. On the basis of the results, the BCF of Y-513 is expected to have a similar value to those of the Component A. A possible explanation for the fact that the BCF value is low, although the Log Kow > 6.5 (the highest Log Kow of the reference substances of the OECD121 study), may be caused by a low bioavailability and/or steric hindrance due to the size of the substances.

In conclusion, Y-513 is considered to have no potential for bioaccumulation.

The validity criteria were fulfilled.

The study is rated Klimisch 2 (reliable with restrictions) because the study is carried out for component A only, whereas the results are used for Y-513, which is a mixture of component A and analogues.