long chain alkyl thio carbamide metal complex

Bioaccumulation: aquatic / sediment

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-02-12 to 1999-05-19

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 305 C (Bioaccumulation: Test for the Degree of Bioconcentration in Fish)

Deviations:

yes

Remarks:

test terminated at 56 days (Guideline - 60 days)

Qualifier:

according to guideline

Guideline:

other: Method for Testing the Degree of Accumulation of Chemical Substances in Fish Body stipulated in Testing Methods for Chemical Substances (Ministry of International Trade and Industry, Japan)

Deviations:

not specified

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Water solubility: <0.8 mg/litre

Radiolabelling:

no

Details on sampling:

- Sampling intervals/frequency for test organisms: 2-week intervals
- Sampling intervals/frequency for test medium samples: twice weekly
- Sample storage conditions before analysis: no data
- Details on sampling and analysis of test organisms and test media samples (e.g. sample preparation, analytical methods):

Test organisms: Homogenised in tetrahydrofuran (THF) and centrifuged; supernatant concentrated and partitioned into CHCl3:NaCl; CHCl3 layer dried and taken up into butyl acetate for atomic absorption spectrophotometry (AA) analysis

Test medium: partitioned between CHCl3: NaCl; CHCl3 layer dried and taken up in THF for HPLC analysis

Vehicle:

yes

Details on preparation of test solutions, spiked fish food or sediment:

PREPARATION OF SPIKED WATER
- Details of spiking: test material plus dispersant were dissolved in tetrahydrofuran (THF). THF was evaporated and deionised water added to make a 1000 mg/litre stock solution.
- Controls: yes
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): dispersant: hydrogenated castor oil and olive oil
- Concentration of vehicle in final test solution: 0.025 g/litre

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Carp
- Strain: no data
- Source: Sugishima fish farm, Kumamoto 866-0024 Japan
- Age at study initiation (mean and range, SD): no data
- Length at study initiation (length definition, mean, range and SD): 9.7 cm
- Weight at study initiation (mean and range, SD): 21.9 g
- Weight at termination (mean and range, SD): no data
- Method of breeding: no data
- Health status: no abnormalities
- Description of housing/holding area: acclimatizing aquarium
- Feeding during test: yes
- Food type: pelleted feed for carp (Nippon Formula Feed Mfg. Co., Ltd)
- Amount: about 2% of total body weight/day
- Frequency: twice/day

ACCLIMATION
- Acclimation period: 104 days
- Acclimation conditions (same as test or not): same
- Type and amount of food: as for study
- Feeding frequency: as for study
- Health during acclimation (any mortality observed): no mortalities reported

Route of exposure:

aqueous

Test type:

flow-through

Water / sediment media type:

natural water: freshwater

Total exposure / uptake duration:

8 wk

Hardness:

111 mg/litre (Ca; Mg)

Test temperature:

25 ± 2 ºC

pH:

7.5

Dissolved oxygen:

For level 1 concentration: 6.6 - 7.6 mg/litre
For level 2 concentration: 7.6 - 8.1 mg/litre
For control: 6.7 - 7.7 mg/litre

TOC:

0.6 mg/litre

Salinity:

not applicable

Details on test conditions:

TEST SYSTEM
- Test vessel: 100-litre glass tank
- Aeration: no data
- Type of flow-through (e.g. peristaltic or proportional diluter): no data
- Renewal rate of test solution (frequency/flow rate): 2 ml/min stock solution; 400 ml/min dilution water - total flow 579 litre/day
- No. of organisms per vessel: 11 (test); 5 (control)
- No. of vessels per concentration (replicates): 1
- No. of vessels per control / vehicle control (replicates): 1
- Biomass loading rate: 214.9 g

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: underground source at Kurume Research Laboratories
- Particulate matter: <1 mg/litre
- Metals: Hg, Pb, Cd, Cr, As, Cu, Fe -- all below detection limit
- Pesticides: no data
- Chlorine: <0.01 mg/litre
- Alkalinity: 98.1 mg/litre
- Ca/mg ratio: no data
- Conductance: 384 µs/cm
- Holding medium different from test medium: same
- Intervals of water quality measurement: every 6 months
- Intervals of test medium replacement: continuous flow

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: no data
- Light intensity: no data

RANGE-FINDING / PRELIMINARY STUDY
- Test concentrations: 80 mg/litre
- Results used to determine the conditions for the definitive study: yes - LC50

Nominal and measured concentrations:

Nominal: level 1: 0.5 mg/litre (as test material)
Nominal: level 2: 0.05 mg/litre (as test material)
Measured: level 1 at weeks 2, 4, 6 and 8: 0.430, 0.438, 0.439 and 0.445 mg/litre respectively
Measured: level 2 at weeks 2, 4, 6 and 8: 0.0379, 0.0375, 0.0376 and 0.0375 mg/litre respectively

Reference substance (positive control):

no

Details on estimation of bioconcentration:

Bioconcentration factor (BCF) = concentration of test material in fish/average concentration of test material in dilution water
No BCFs calculated because the measured concentrations of the test material in the test fish were below the limit of detection

Lipid content:

4.1 %

Time point:

start of exposure

Remarks on result:

other: average value

Key result

Conc. / dose:

0.5 mg/L

Temp.:

25 °C

Type:

BCF

Value:

<= 7.4 dimensionless

Basis:

whole body w.w.

Key result

Conc. / dose:

0.05 mg/L

Temp.:

25 °C

Type:

BCF

Value:

<= 88 dimensionless

Basis:

whole body w.w.

Details on kinetic parameters:

No bioaccumulation detected

Metabolites:

not done

Results with reference substance (positive control):

not done

Details on results:

- Mortality of test organisms: none
- Behavioural abnormalities: none
- Observations on body length and weight:
body weight (n=2) at 2, 4, 6 and 8 weeks (0.05 mg/litre nominal dose) - 33.2/40.0; 38.5/41.2; 44.9/50.0 and 51.8/46.8 respectively
body weight (n=2) at 2, 4, 6 and 8 weeks (0.5 mg/litre nominal dose) - 35.6/40.3; 45.1/47.5; 43.1/45.5 and 42.8/56.9 respectively
body weight (n=2) of control fish at termination of study - 52.0/45.1
- Other biological observations: appearance
- Organ specific bioaccumulation: not applicable
- Bound residues forming a plateau: not applicable
- Mortality and/or behavioural abnormalities of control: none
- Loss of test substance during test period: no

Reported statistics:

none

Validity criteria fulfilled:

yes

Conclusions:

In a GLP study conducted according to a protocol equivalent to OECD guideline 305C, no bioaccumulation of EC# 434-650-5 was detected in carp following exposure for up to 8 weeks at concentrations of 0.5 and 0.05 mg/litre in a continuous flow apparatus, resulting in bioaccumulation factors of <7.4 and <88 respectively.

Executive summary:

In a GLP study conducted according to a protocol equivalent to OECD guideline 305C, the bioaccumulation in carp (Cyprinus carpio) of EC#434-320-2 was evaluated in a continuous flow system. Groups of eleven fish were exposed at two concentrations of test material 0.05 and 0.5 mg/litre for a period of 8 weeks, the concentrations of test material in the medium being determined twice weekly and at two-week intervals in the fish. A further group of five fish was exposed to medium only.

No deaths and no abnormalities in behaviour or appearance were seen in the fish during the study. No change in the concentration of test material in the medium was detected over the study period, varying from 0.430 to 0.445 mg/litre at the higher concentration (0.5 mg/litre nominal) and 0.0375 to 0.0379 mg/litre at the lower concentration (0.05 mg/litre nominal). No bioaccumulation of the test material was detected in the exposed fish during the study, the measured concentrations in the whole body being below the limit of quantitation of the assay (3.3 µg/g body weight for a fish weighing 30 g) at all time points.

In conclusion, based on the analytical detection limits of the test material, the bioconcentration factor (BCF) for EC# 434-650-5 in fish exposed at 0.5 and 0.05 mg/litre was <7.4 and <88 respectively. In view of the structural and chemical similarities, it is considered that the results of this study can be used for read-across to EC# 457-320-2.

Reference 2

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reason / purpose for cross-reference:

read-across source

Lipid content:

4.1 %

Time point:

start of exposure

Key result

Conc. / dose:

0.5 mg/L

Temp.:

25 °C

Type:

BCF

Value:

<= 7.4 dimensionless

Basis:

whole body w.w.

Key result

Conc. / dose:

0.05 mg/L

Temp.:

25 °C

Type:

BCF

Value:

<= 88 dimensionless

Basis:

whole body w.w.

Validity criteria fulfilled:

yes

Conclusions:

In a GLP study conducted according to a protocol equivalent to OECD guideline 305C, no bioaccumulation of EC# 434-650-5 was detected in carp following exposure for up to 8 weeks at concentrations of 0.5 and 0.05 mg/litre in a continuous flow apparatus, resulting in bioaccumulation factors of <7.4 and <88 respectively.

Executive summary:

Based on the analytical detection limits of the test material, the bioconcentration factor (BCF) for EC# 434-650-5 in fish exposed at 0.5 and 0.05 mg/litre was <7.4 and <88 respectively. In view of the structural and chemical similarities, it is considered that the results of this study can be used for read-across to EC# 457-320-2.

Description of key information

In a GLP study on a structurally similar analogue material conducted according to a protocol equivalent to OECD guideline 305C, no bioaccumulation of EC# 434-650-5 was detected in carp following exposure for up to 8 weeks at concentrations of 0.5 and 0.05 mg/litre in a continuous flow apparatus, resulting in bioaccumulation factors of <7.4 and <88 respectively.

Key value for chemical safety assessment

BCF (aquatic species):

88 dimensionless