Registration Dossier

Environmental fate & pathways

Bioaccumulation: aquatic / sediment

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
bioaccumulation in aquatic species: fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Jul - 09 Sep 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
- Name of test material (as cited in study report): C-SAT 070029
- Physical state: amber-cloured, viscous liquid
- Analytical purity: >98% (95.6% C9 Aldoxime, 1-2% Nonyl-4-H-1,3-benzodioxin, 1.5 – 2% toluene as solvent)
- Lot/batch No.: JB 620-70-1
- Expiration date of the lot/batch: 2011-10-11
- Storage condition of test material: room temperature, dark
Radiolabelling:
no
Details on sampling:
- Sampling intervals/frequency for test organisms: 2 fish were pooled and analysed from each test item group sampled on days 2, 6, 14 and 28 of the uptake phase as well as on days 1, 4, 8, 14 and 21 of the depuration phase. Only one fish was analysed on day 28 of the uptake phase.
- Sampling intervals/frequency for test medium samples: Aqueous phase samples from both test item groups were analysed from the uptake phase days 0.5, 1, 2, 21, 26, 27 and 28 and on days 0.5 and 1 of the depuration phase.
Vehicle:
yes
Details on preparation of test solutions, spiked fish food or sediment:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Stock solutions were prepared by adding the respective amount test material to the test media.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): methanol
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): 0.1 mL/L
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Source: Forellenzucht Kasselmann, Forelletal 12, Hagen, Germany
- Age at study initiation (mean and range, SD): approx. 5 month
- Length at study initiation (lenght definition, mean, range and SD): 8 +/- 4 cm
- Weight at study initiation (mean and range, SD): 2-3 g
- Weight at termination (mean and range, SD): 10-12 g
- Feeding during test
- Food type: Aller Performa Gr.2
- Amount: 2% of body weight
- Frequency: twice daily

ACCLIMATION
- Acclimation period: at least 12 days
- Acclimation conditions (same as test or not): same
- Type and amount of food: same as test
- Health during acclimation (any mortality observed): < 5% within the last 7 days before test start
Route of exposure:
aqueous
Test type:
flow-through
Water / sediment media type:
natural water: freshwater
Total exposure / uptake duration:
ca. 28 d
Total depuration duration:
ca. 21 d
Hardness:
64 - 66 mg/L as CaCO3
Test temperature:
14.5 - 16.3 °C
pH:
7.22 - 7.61
Dissolved oxygen:
87 - 100% saturation
Details on test conditions:
TEST SYSTEM
- Test vessel: 200 L glass aquaria covered by glass tops and a fill volume of 120 L test solution
- Aeration: gentle aeration
- Renewal rate of test solution (frequency/flow rate): 25 L/h resulting in 5 volume replacement per day
- No. of organisms per vessel: 85
- No. of vessels per concentration (replicates): 1
- No. of vessels per control / vehicle control (replicates): 1
- Biomass loading rate: The nominal loading rate did not exceed a range of 0.1 to 1.0 g of fish/L/d.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline
- Holding medium different from test medium: no
- Intervals of water quality measurement: Oxygen saturation and pH was measured three times per week in all test vessels (on day 2, 5, 7, 9, 12, 14, 16, 19, 21, 23, 26, 28, 30, 33, 35, 37, 40, 42, 44 and 48). Temperature was measured continuously (every hour) using data logger.

OTHER TEST CONDITIONS
- Photoperiod: diurnal light with 16 hlight and 8 h dark
- Light intensity: 0.1 - 10 µmol/m2/s
Nominal and measured concentrations:
Nominal: 7 and 35 µg/L with recovery of 35-68% (mean 50%) and 31-51% (mean 38%), respectively
Reference substance (positive control):
no
Details on estimation of bioconcentration:
BASIS INFORMATION
- Measured/calculated logPow: > 3.5 (at 25°C), estimated 5.86 (Kowwin 1.67)

Because of the very short depuration phase, steady state BCF have been calculated from the repsective concentrations in fish and water
Lipid content:
1.84 - 5.21 %
Time point:
start of exposure
Remarks on result:
other:
Remarks:
mean: 3.01%
Lipid content:
4.56 - 8.2 %
Time point:
end of exposure
Remarks on result:
other:
Remarks:
mean: 6.6%
Key result
Conc. / dose:
35 µg/L
Type:
BCF
Value:
165 dimensionless
Basis:
normalised lipid fraction
Remarks:
(5%)
Time of plateau:
6 d
Calculation basis:
steady state
Conc. / dose:
35 µg/L
Type:
BCF
Value:
159 dimensionless
Basis:
other: whole body weight and total fat
Time of plateau:
6 d
Calculation basis:
steady state
Conc. / dose:
7 µg/L
Type:
BCF
Value:
138 dimensionless
Basis:
other: whole body weight and total fat
Time of plateau:
6 d
Calculation basis:
steady state
Key result
Elimination:
yes
Parameter:
other: below limit of quantification of 0.35 µg/l
Depuration time (DT):
8 d
Details on results:
- Mortality of test organisms: one fish died on day 9 in the low concentration group
- Behavioural abnormalities: no abnormal feeding behaviour
- Observations on body length and weight: no stat. significant differences in growth rates in the groups (incl. negative control)
- Mortality and/or behavioural abnormalities of control: no

Uptake phase: The uptake phase was characterised by a distinct increase of the concentration of the test substance in the fish within 6 days followed by a clear plateau phase (steady state phase) where no further increase was found. The plateau phase was observed for both exposure levels from day 6 to day 28 (22 days). The mean measured concentrations of the water samples were 3.5 and 13.4 µg/L (50 % and 38 % of the nominal concentrations), respectively.

Depuration phase: After the transfer of the remaining fish to untreated water a rapid decrease of the concentration of the test substance in the fish was observed. The concentration in the fish of the lower exposure group of 7 1 µg/L had dropped below the limit of quantification on day 4 of the depuration phase. At the higher exposure group (35 µg/L) this was observed on day 8.

Validity criteria fulfilled:
yes
Conclusions:
As steady state BCF were <=159 (log BCF <= 2.2) and depuration took place within 4 to 8 days, it can be concluded that the test substance does not accumulate remarkably in fish.
Executive summary:

The test substance was tested for its bioaccumulation in a study according to OECD Guideline 305 (Bioconcentration: Flow-through Fish Test) using the species Oncorhynchus mykiss under GLP conditions. The fish were exposed for 4 weeks followed by a three week depuration period. the two concentration of 7 and 35 µg/l were used. Based on whole body weight and total fat and assuming steady state, for both concentrations a plateau was reached after 6 days. The BCF were approx. 138 and 159, respectively. While one fish died, neither abnormal behaviour nor abnormal growth was observed. Depuration was achieved after 4 and 8 days, respectively.

From the low BCF and the depuration, it can be concluded that the test substance does not accumulate remarkably in fish.

Description of key information

Benzaldehyde, 2-hydroxy-5-nonyl, oxime, branched does not bioaccumulate in aquatic or sediment organisms.

Key value for chemical safety assessment

BCF (aquatic species):
159 dimensionless

Additional information

The registered substance has been tested for its bioaccumulation in a study according to OECD Guideline 305 (Bioconcentration: Flow-through Fish Test) using the species Oncorhynchus mykiss under GLP conditions. The fish were exposed for 4 weeks followed by a three week depuration period. the two concentration of 7 and 35 µg/l were used. Based on whole body weight and total fat and assuming steady state, for both concentrations a plateau was reached after 6 days. The BCF were 138 and 159, respectively. While one fish died, neither abnormal behaviour nor abnormal growth was observed. Depuration was achieved after 4 and 8 days, respectively. From the low BCF and the depuration, it can be concluded that the test substance does not accumulate remarkably in fish.