Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

Hydrolysis

Thehydrolysisof the substance was determined by EEC Directive 92/69 (1992) - Method C7. At pH 4, 7 and 9, less than 10 % hydrolysis is observed after 5 days.

 

Biodegradation

301B From the results obtained under the experimental conditions employed, the evaluation of the biotic degradation of the test article using the modified Sturm test showed: Biodegradation of the test article after 28 days= 3 %. This test article can be considered as: Not readily biodegradable.

301C The test substance was not biodegraded by microorganisms under the present test conditions. The percentage biodegradation after 28 days were as follows, each calculated as average value from 3 test vessels:BOD 0 % biodegradation, HPLC 2 % biodegradation.

 

Bioaccumulation

This test was performed to evaluate the bioconcentration potential of the test substance in carp.

This test was performed according to the "Method for Testing the Degree of Accumulation of Chemical Substances in Fish Body" stipulated in the "Testing Methods for New Chemical Substances" (July 13, 1974, Revised October 8, 1998, No.5, Planning and Coordination Bureau, Environment Agency; No.615, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare; and No.392, Basic Industries Bureau, Ministry of International Trade and Industry, Japan). This test method was essentially the same as that in the OECD Guidelines for Testing of Chemicals, "Bioconcentration: Flow-through Fish Test (Guideline 305, June 14, 1996)".

 

This test complied with OECD Principles of Good Laboratory Practice.

Based on preliminary test results for the 96-hour LC50 value and analytical detection limits, test concentrations of the test substance were decided as follows. The control was set as a blank test.

Level l: 0.5 mg/L,  Level 2: 0.05 mg/L

Analysis of the test substance in test water and test fish was performed with high-performance liquid chromatography (HPLC) analysis.

The measured concentrations of test substance were not more than the determination limit.

Determination limit of the test substance in test fish was calculated to be 0.12 µg/g.

 

On the basis of the minimum detection limit of the test substance, BCF can be obtained when BCF exceeds the following:

Level 1: 0.26

Level 2: 2.6

Since all the measured concentrations of test substance in fish were below the determination limit, the calculated BCFs can’t be above:

Level 1:  0.26

Level 2:  2.6

Therefore, it can be concluded that the substances has no potential for bioaccumulation.

Since all the measured concentrations of test substance in fish were below the detection limit, the values given represent the calculated maximum BCFs at detection limit.

 

 

Adsorption/Desorption

The log Koc of the substance was calculated by KOCWIN Program (v2.00). Due to the estimated Log Koc = 0.9553, adsorption of the substance to soil is not to be expected.

In a second study the estimation was performed based on a water solubility of 139 mg/l at pH 10 (Pharmacon Europe Report No. 47595) using regression equations (Lyman, Reehl, Rosenblatt: Handbook of Chemical Property Estimation Methods, 1990) relating the Koc with the water solubility. Furthermore, the molecular weight of the substance, i.e. 442.7 g/mol was used. The adsorption coefficient of the substance was determined by calculation. It resulted in a Koc value of 97 meaning that the substance is considered as moderately mobile in soils.