Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Environmental fate & pathways

Bioaccumulation: aquatic / sediment

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
bioaccumulation: aquatic / sediment
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from authoritative database
Qualifier:
according to guideline
Guideline:
other: refer below principle
Principles of method if other than guideline:
Environmental Bioconcentration of test chemical was estimated using a log Kow and a regression-derived equation.
GLP compliance:
no
Radiolabelling:
no
Vehicle:
no
Test organisms (species):
other: aquatic organisms
Route of exposure:
aqueous
Test type:
flow-through
Water / sediment media type:
natural water: freshwater
Reference substance (positive control):
no
Details on estimation of bioconcentration:
BASIS FOR CALCULATION OF BCF
- Result based on calculated logKow of: 1.88
Type:
BCF
Value:
8 dimensionless
Basis:
whole body w.w.
Calculation basis:
other: BCF was calculated Using a log Kow of 1.88 and a regression-derived equation
Remarks on result:
other: other details not available
Details on results:
Bioaccumulation factor (BCF) of test chemical was estimated to be 8 dimensionless.
Validity criteria fulfilled:
not specified
Conclusions:
Bioaccumulation factor (BCF) of test chemical was estimated to be 8 dimensionless.
Executive summary:

The bioaccumulation study was conducted for estimating the BCF (bioaccumulation factor) value of test chemical. The bioaccumulation factor (BCF) value was calculated using a log Kow of 1.88 and a regression-derived equation. The BCF value of test chemical was estimated to be 8 dimensionless, which does not exceed the bioconcentration threshold of 2000, indicating that the test chemical is non-bioaccumulative in aquatic organisms.

Description of key information

Aim of the study was to determine bioconcentration factor (BCF) of test chemical in test organism. Study was performed for 6 weeks of depuration time. Test was conducted on juvenile hybrid striped bass (Morone chrysops and M. saxatilis) with an average weight of 10 g. Test organisms were purchased from Delmarva Aquatics and acclimatized to laboratory conditions over a period of 2 weeks. Test organisms were kept in round fibre glass 170 L tanks fitted with a drain at the centre and a flow-through system in which the water flow rate was 2 L/min. Aeration was supplied through large air stone present in each tank. A total of six tanks were used, three for the control and three for the experimental group. The water temperature fluctuated between 19 and 22°C throughout the experimental period. A total of 22 fish were stocked in each tank. Fish were fed with the pelleted feed (ASD2-30) containing 56.6% protein, 14.6% fat and 8.9% ash twice a day (early morning and late afternoon) for 5 days, and once a day during the remaining 2 days of the week. Food was stored in sealed plastic containers in a freezer (-20°C) and the daily ration was removed from the freezer and left to thaw fully before feeding the fish. Test was carried out under flow-through condition at pH of 6.6-7.2 and 19-22°C temperature. During the test dissolved oxygen was fluctuated between 5.3 and 7.2mg/L and the photoperiod were maintained at 12L: 12D with artificial fluorescent illumination. The dissolved oxygen monitored with the aid of an YSI (Yellow Springs Instruments oxygen meter. The fish were food deprived for1day at the end of 6-week growth period and a sample of fish from each tank was removed. The fish were decapitated their digestive tracts were dissected and the different tissues were placed in test tubes. 2mL solution of 0.1% sodium azide (NaN3) was added in test tubes to prevent microbial degradation. Different body parts of fish, scales and outer surface mucus, liver, spleen, fat bodies and the muscle near the dorsal fin. Samples were then sealed and kept frozen at -20°C until analysis. 6 weeks chemical exposure period was provided to test fishes. The experiment was further extended for additional 6 weeks and the fish were assayed following a depuration period in which previously test chemical-fed fish were given the control diet (containing no additional test chemical) and after the exposure period, the fishes were observed for the presence of residual test chemical. Tissue and food samples were extracted by using A SpeedVac Savant Concentrator, a 220 ultrasonic bath and an EIC HN-S II centrifuge. HPLC was performed using a Raining HPXL two-pump solvent delivery system, Rheodyne 7161 sample injector equipped with a 20mL sample loop. The detection was carried out by a Dynamax FL-1 fluorescent detector. Chromatograms were recorded and integrated using a Hewlett Packard 3390A integrator. The results were subjected to ANOVA followed by Tukey ’s pair test. The BCF of test chemical was determined to be 6.7 ±1.8, 8.9±2.1, 11.2±2.6, 0.1±0.05 µg/g in spleen, liver, abdominal fat and in muscle, respectively while traces of test chemical were found in scales and mucus. The deposition rate of test chemical in the hybrid striped bass fed feed adulterated with 100 mg/kg of test chemical corresponded to 0.7%. The experimental BCF value does not exceed the bioconcentration threshold of 2000, indicating that the test chemical is considered to be non-accumulative in aquatic organisms.

Key value for chemical safety assessment

Additional information

Following different studies includes experimental study to observe the bioaccumulation of test chemical:

 

Aim of the first study was to determine bioconcentration factor (BCF) of test chemical in test organism. Study was performed for 6 weeks of depuration time. Test was conducted on juvenile hybrid striped bass (Morone chrysops and M. saxatilis) with an average weight of 10 g. Test organisms were purchased from Delmarva Aquatics and acclimatized to laboratory conditions over a period of 2 weeks. Test organisms were kept in round fibre glass 170 L tanks fitted with a drain at the centre and a flow-through system in which the water flow rate was 2 L/min. Aeration was supplied through large air stone present in each tank. A total of six tanks were used, three for the control and three for the experimental group. The water temperature fluctuated between 19 and 22°C throughout the experimental period. A total of 22 fish were stocked in each tank. Fish were fed with the pelleted feed (ASD2-30) containing 56.6% protein, 14.6% fat and 8.9% ash twice a day (early morning and late afternoon) for 5 days, and once a day during the remaining 2 days of the week. Food was stored in sealed plastic containers in a freezer (-20°C) and the daily ration was removed from the freezer and left to thaw fully before feeding the fish. Test was carried out under flow-through condition at pH of 6.6-7.2 and 19-22°C temperature. During the test dissolved oxygen was fluctuated between 5.3 and 7.2mg/L and the photoperiod were maintained at 12L: 12D with artificial fluorescent illumination. The dissolved oxygen monitored with the aid of an YSI (Yellow Springs Instruments oxygen meter. The fish were food deprived for1day at the end of 6-week growth period and a sample of fish from each tank was removed. The fish were decapitated their digestive tracts were dissected and the different tissues were placed in test tubes. 2mL solution of 0.1% sodium azide (NaN3) was added in test tubes to prevent microbial degradation. Different body parts of fish, scales and outer surface mucus, liver, spleen, fat bodies and the muscle near the dorsal fin. Samples were then sealed and kept frozen at -20°C until analysis. 6 weeks chemical exposure period was provided to test fishes. The experiment was further extended for additional 6 weeks and the fish were assayed following a depuration period in which previously test chemical-fed fish were given the control diet (containing no additional test chemical) and after the exposure period, the fishes were observed for the presence of residual test chemical. Tissue and food samples were extracted by using A SpeedVac Savant Concentrator, a 220 ultrasonic bath and an EIC HN-S II centrifuge. HPLC was performed using a Raining HPXL two-pump solvent delivery system, Rheodyne 7161 sample injector equipped with a 20mL sample loop. The detection was carried out by a Dynamax FL-1 fluorescent detector. Chromatograms were recorded and integrated using a Hewlett Packard 3390A integrator. The results were subjected to ANOVA followed by Tukey ’s pair test. The BCF of test chemical was determined to be 6.7 ±1.8, 8.9±2.1, 11.2±2.6, 0.1±0.05 µg/g in spleen, liver, abdominal fat and in muscle, respectively while traces of test chemical were found in scales and mucus. The deposition rate of test chemical in the hybrid striped bass fed feed adulterated with 100 mg/kg of test chemical corresponded to 0.7%. The experimental BCF value does not exceed the bioconcentration threshold of 2000, indicating that the test chemical is non-bioaccumulative in aquatic organisms.

 

Second study was conducted to determine bioconcentration factor (BCF) of test chemical in test organism. Study was performed for 6 weeks of depuration time. Test was conducted on African cichlid fish Aulonocara jacobfreibergi with an average weight of 1 g. Test organisms were purchased from Schmalbach farm and acclimatized to laboratory conditions over a period of 10 days. Fishes were maintained in glass aquariums containing 35L of water. Each aquarium was equipped with an internal biofilter through which air was bubbled at a constant rate. The total no. of test vessel used during study was twelve, six for the control-fed fish and six for the experimental group. The temperature was maintained at 25±2°C by heating the room in which the experiment was run. Fishes were fed with the pelleted feed (ASD2-30) containing 56.6% protein, 14.6% fat and 8.9% ash twice a day (early morning and late afternoon) for 5 days, and once a day during the remaining 2 days of the week. Food was stored in sealed plastic containers in a freezer (-20°C) and the daily ration was removed from the freezer and left to thaw fully before feeding the fish. Test was carried out under flow-through condition at pH of 6.6-7.2. During the test dissolved oxygen was fluctuated between 5.3 and 7.2mg/L and the photoperiod were maintained at 12L: 12D with artificial fluorescent illumination. The dissolved oxygen monitored with the aid of an YSI (Yellow Springs Instruments oxygen meter. The fish were food deprived for 1 day at the end of 6-week growth period and a sample of fish from each tank was removed. The fish were decapitated their digestive tracts were dissected and the different tissues were placed in test tubes. 2mL solution of 0.1% sodium azide (NaN3) was added in test tubes to prevent microbial degradation. Tissue and food samples were extracted by using A SpeedVac Savant Concentrator, a 220 ultrasonic bath and an EIC HN-S II centrifuge. HPLC was performed using a Raining HPXL two-pump solvent delivery system, Rheodyne 7161 sample injector equipped with a 20mL sample loop. The detection was carried out by a Dynamax FL-1 fluorescent detector. Chromatograms were recorded and integrated using a Hewlett Packard 3390A integrator. The results were subjected to ANOVA followed by Tukey ’s pair test. The BCF of test chemical was determined to be 12.7±2.1µg/g based on the whole body accumulation or food intake level. Deposition rate of test chemical in juvenile African cichlid fish Aulonocara jacobfreibergi (whole-body accumulation/food intake level) was observed to be of 0.3%. The experimental BCF value does not exceed the bioconcentration threshold of 2000, indicating that the test chemical is non-bioaccumulative in aquatic organisms.

 

The last bioaccumulation study was conducted for estimating the BCF (bioaccumulation factor) value of test chemical. The bioaccumulation factor (BCF) value was calculated using a log Kow of 1.88 and a regression-derived equation. The BCF value of test chemical was estimated to be 8 dimensionless, which does not exceed the bioconcentration threshold of 2000, indicating that the test chemical is non-bioaccumulative in aquatic organisms.

 

Based on the above experimental BCF value does not exceed the bioconcentration threshold of 2000, indicating that the test chemical is non-bioaccumulative in aquatic organisms.