Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Bioaccumulation:aquatic/sediment:

Bioaccumulation test was conducted for 8 weeks by using test guideline "Bioaccumulation test of a chemical substance in fish or shellfish" provided in "the Notice on the Test Method Concerning New Chemical Substances"for determination the bioconcentration factor (BCF) of substance on test organism Cyprinus carpio.

The recovery ratio is given- Test water: 1st concentration area: 91.4 %, 2nd concentration area: 84.1 %, Fish: 73.5 %, Vehicle used as Tween 80 with concentrations 1st Concentration area: 1 ppm(w/v), 2nd Concentration area: 0.1 ppm(w/v) respectively.

And Nominal concentrations used in the study as - 1st Concentration area: 0.1 ppm(w/v), 2nd Concentration area : 0.01 ppm(w/v) and Range finding study was carried out on Rice fish (Oryzias latipes) and the 48 hr TLm(48h) 5.05 ppm(w/v). 

Thus according to static Fish Test the BCF value for test substance was observed to be 34-143 L/kg at dose concentration 0.1 ppm(w/v) and 38- 235 L/kg at dose concentration 0.01 ppm(w/v) on test organism Cyprinus carpio during 8 weeks period.

These BCF values indicate that the substance is not bioaccumulative in fish and food chain.

Additional information

Bioaccumulation: aquatic/sediment:

Experimental studies and one predicted study of test chemical were reviewed for bioaccumulation endpoint and their results are summarized below.

The first study was experimental study in this study the Bioaccumulation test was conducted for 8 weeks for determination the bioconcentration factor (BCF) of substance on test organism Cyprinus carpio.

The recovery ratio is given- Test water: 1st concentration area: 91.4 %, 2nd concentration area: 84.1 %, Fish: 73.5 %, Vehicle used as Tween 80 with concentrations 1st Concentration area: 1 ppm(w/v), 2nd Concentration area: 0.1 ppm(w/v) respectively.

And Nominal concentrations used in the study as - 1st Concentration area: 0.1 ppm(w/v), 2nd Concentration area : 0.01 ppm(w/v) and Range finding study was carried out on Rice fish (Oryzias latipes) and the 48 hr TLm(48h) 5.05 ppm(w/v). 

Thus according to static Fish Test the BCF value for test substance was observed to be 34-143 L/kg at dose concentration 0.1 ppm(w/v) and 38- 235 L/kg at dose concentration 0.01 ppm(w/v) on test organism Cyprinus carpio during 8 weeks period.

These BCF values indicate that the substance is not bioaccumulative in fish and food chain.

Next study was reviewed from authorative database HSDB, the bioaccumulation factor (BCF) of test chemical in aquatic organisms was estimated to be 3.0 dimensionless using an estimated log Kow of 3.15 and a regression derived equation.This BCF suggests the potential for bioconcentration in aquatic organisms is low.

To support the results of above mentioned studies one prediction was done by using BCFBAF Program (v3.00) model of EPI suite in this the bio concentration factor (BCF) for test chemical was estimated to be 56 L/kg wet-wt which does not exceed the bioconcentration threshold of 2000.Thus it is concluded that test chemical is not expected to bio accumulate in the aquatic environment.

By considering results of all the studies mentioned above it is concluded that BCF value of test chemical is in range of 3.0 to 235 L/kg. On the basis of this range value it is concluded that test chemical is non bioaccumulatie in nature.