1,3,5-Triazine-2,4-diamine, N2-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-yl]-6-(1-fluoroethyl)-

Bioaccumulation: aquatic / sediment

Link to relevant study record(s)

Reference

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)

Qualifier:

according to guideline

Guideline:

EPA OPP 165-4 (Laboratory Studies of Pesticide Accumulation in Fish)

Qualifier:

according to guideline

Guideline:

EPA OPP 72-6 (Aquatic Organism Accumulation Tests)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1730 (Fish Bioconcentration Test)

GLP compliance:

yes (incl. QA statement)

Radiolabelling:

yes

Vehicle:

yes

Test organisms (species):

Lepomis macrochirus

Details on test organisms:

TEST ORGANISM
- Common name: Bluegill Sunfish
- Source: Osage Catfisheries, Inc. (Osage Beach, MO)
- Length at study initiation: 4.9 ± 0.2 cm (mean ± SD)
- Weight at study initiation: 1.6 ± 0.3 g (mean ± SD)
- Health status: Healthy (<3% mortality during the acclimation period; no mortalities during the 48 hours immediately prior to testing)

ACCLIMATION
- Acclimation period: > 14 days
- Acclimation conditions: Fish were acclimated in culture tanks to soft process water, test temperature (22 ± 2°C), and photoperiod (16 hours light/8 hours dark)
- Type of food: commercial fish diet
- Feeding frequency: daily

Route of exposure:

aqueous

Test type:

flow-through

Water / sediment media type:

natural water: freshwater

Total exposure / uptake duration:

26 d

Total depuration duration:

14 d

Hardness:

48 - 50 mg mg/L CaCO3

Test temperature:

22 ± 1°C

pH:

7.6 - 8.1

Dissolved oxygen:

above 60% saturation at all times

TOC:

TOC values during the uptake phase of the study (days 0 to 26) ranged from 23.3 to 58.5 µg carbon/mL.
TOC values measured prior to test initiation and during the depuration period were <0.5 µg carbon/mL (method limit of quantitation).

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers
- Material, size, headspace, fill volume: glass aquaria [60 cm (L) x 56 cm (W) x 30 cm (H)] with a water volume of 80 liters
- Type of flow-through: continuously flow through via a stand pipe
- Renewal rate of test solution (flow rate): approximately 6 times in a 24-hour period.
- No. of organisms per vessel: 76 fish (bioconcentration portion) and 30 (for the biotransformation study)
- No. of vessels per concentration (replicates): 1
- No. of vessels per control / vehicle control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline (Dilution water (soft process water) used in the Bayer CropScience Ecotoxicology Laboratory consists of on-site spring water blended with reverse osmosis water designed to produce soft water (40 to 60 mg/L as CaCO3). Both water types are screened semiannually for contaminants (e.g., pesticides and heavy metals) by an indpendent laboratory.


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16-hour light and 8-hour dark photoperiod and with a 30-min dawn/dusk transition period.
- Light intensity: 778 to 1006 lux (mean 885 lux)

Nominal and measured concentrations:

Nominal concentration: 0.3 and 3.0 μg ai/L

Type:

BCF

Value:

11 dimensionless

Basis:

whole body d.w.

Remarks:

normalized to 6% lipid content

Calculation basis:

steady state

Remarks:

normalized to 6% lipid content

Type:

BCF

Value:

16 dimensionless

Basis:

whole body w.w.

Calculation basis:

steady state

For the biotransformation portion of the study, one group with 30 fish was exposed to a nominal concentration of 3.0 µg [triazine-2,4-14C] AE 1170437/L dilution water (0.1 mL MeOH/L dilution water; Aquarium D).

The average steady-state bioconcentration factors (BCFss) were 25.0 (edible tissue) and 46.0 (whole fish) for Aquarium B (low dose) and of 26.7 (edible tissue) and 51.1 (whole fish) for Aquarium C (high dose).

The time to reach 95% of Steady State ranged from 2.6 days in the non-edible tissue samples from Aquarium B (low dose) to 3.4 days in the non-edible tissue samples from Aquarium C (high dose). The half-life for clearance (t(1/2)) ranged from 0.59 days in the

non-edible tissue samples from Aquarium B (low dose) to 0.78 days in the non-edible tissue samples from Aquarium C (high dose). After 14 days in uncontaminated water, greater than 98% of the mean plateau radioactivity depurated from whole fish at both the low and high test levels.

The uptake rate constants (ku) were 24.1, 96.8, and 49.7 day-1 for the edible tissue, non-edible tissue, and whole fish samples from Aquarium B (low dose) and 28.6, 85.4, and 51.4 day-1 for the edible tissue, non-edible tissue, and whole fish samples from Aquarium C (high dose). The depuration rate constants (kd) were 0.939, 1.17, and 1.03 day-1 for the edible tissue, non-edible tissue, and whole fish samples from Aquarium B (low dose) and 1.01, 0.888, and 0.932 day-1 for the edible tissue, non-edible tissue, and whole fish samples from Aquarium C (high dose).

The kinetic bioconcentration factors (BCFk) were 25.6 and 28.4 in the edible tissue from Aquaria B and C, respectively, 82.5 and 96.2 in the non-edible tissue from Aquaria B and C, respectively, and 48.4 and 55.1 in the whole fish from Aquaria B and C, respectively. The major residue in all fish tissues was parent AE 1170437 (average of 34.5% and 29.5% of the TRR in the edible and non-edible tissue, respectively). The average percent lipid in all whole fish samples from Aquaria A, B, and C at all collection time points was 9.14%.

The steady-state BCF for parent AE 1170437 based on whole fish (wet weight) is 16, and the steady-state BCF for parent AE 1170437 normalized to 6% lipid content is 11.

Description of key information

The substance has no potential to bioaccumulate in aquatic organisms.

Key value for chemical safety assessment

BCF (aquatic species):

11 dimensionless

Additional information

A study was conducted to determine the bioconcentration potential of the test substance from the aqueous environment into bluegill sunfish(Lepomis macrochirus) using a flow-through exposure system. The bioconcentration of the substance in bluegill sunfish was determined in a 40-day continuous flow-through study, which included a 26-day uptake period and a 14-day depuration period according to OECD 305.

The average steady-state bioconcentration factors (BCFss) were 25.0 (edible tissue) and 46.0 (whole fish) for the low dose(0.3 µg/L) and of 26.7 (edible tissue) and 51.1 (whole fish) for the high dose (3.0 µg/L). The time to reach 95% of Steady State ranged from 2.6 days in the non-edible tissue samples from Aquarium B (low dose) to 3.4 days in the non-edible tissue samples from Aquarium C (high dose). The half-life for clearance (t(1/2)) ranged from 0.59 days in the non-edible tissue samples from Aquarium B (low dose) to 0.78 days in the non-edible tissue samples from Aquarium C (high dose). After 14 days in uncontaminated water, greater than 98% of the mean plateau radioactivity depurated from whole fish at both the low and high test levels.

 The steady-state BCF for the substance based on whole fish (wet weight) is 16, and the steady-state BCF for the substance normalized to 6% lipid content is 11.

Therefore, there are no indications for a bioaccumulation potential of the test substance.