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

Sediment toxicity

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

sediment toxicity: short-term

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:

EPA OPPTS 850.1735 (Whole Sediment Acute Toxicity of Invertebrates, freshwater)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
The TGAS coded AE1170437 used at the initiation of this study includes multiple isomers, including the isomers AE1170437 (principle active substance) and AE1170438 (active isomer of the principle active substance). Since the biological activity of AE1170438 is similar to AE1170437, both are regarded as active substances in the TGAS. The TGAS contains 95% (94.5%) to 100% AE1170437 and, 0 % to 5 % (5.3 %) AE1170438. In order to distinguish between the single diastereomer AE1170437, and the TGAS containing both AE1170437 and AE1170438, a new BCS code, BCS-AA10717, has been designated for the TGAS mixture of stereoisomers. All references to the technical active substance and analytical results as AE1170437 are equivalent to the newly established TGAS: BCS-AA10717

Analytical monitoring:

yes

Vehicle:

yes

Details on sediment and application:

PREPARATION OF SPIKED SEDIMENT:
A jar-rolling technique was used to apply the test substance to the sediment (Ditsworth et al., 1990). A 9.0-mL volume of each dosing stock solution was applied to 0.0500 kg of fine silica sand placed in glass Petri dishes. The solvent was allowed to evaporate off the sand for 30 minutes. The dry sand, containing the test substance, was then added to the 2.0 kg of wet sediment (1.3592 kg dry weight based on a percent solids of 67.96%) in individual one-gallon jars. The total mass of sediment spiked on a dry weight basis for each treatment level and control was 1.4092 kg (0.0500 kg sand and 1.3592 kg dry weight sediment). The jars were sealed and positioned horizontally on the rolling mill. Each jar was then rolled for four hours at room temperature at approximately 15 rpm. Following the four hours of rolling, the jars were stored upright at 4 oC. The sediments were allowed to equilibrate for a 30-day period in the refrigerator. Once weekly during the 30-day equilibration period and prior to addition into the replicate exposure vessels (test day –1), the jars were mixed on the rolling mill for an additional two hours at room temperature to ensure the sediment was homogeneous.

Test organisms (species):

Chironomus dilutus (previous name: Chironomus tentans)

Details on test organisms:

TEST ORGANISM
- Common name: dipteran midge
- Source: Springborn Smithers culture
- Age of animals at beginning of exposure: 10 to 11 days
- Feeding during test
- Food type: flaked fish food suspension
- Amount: 1.5 mL of a 4.0 mg/mL flaked food suspension
- Frequency: daily

ACCLIMATION
- Acclimation period: 10 to 11 days from hatching until test start
- Acclimation conditions (same as test or not): same as test
- Health during acclimation (any mortality observed): No midge mortality was observed in the test population 48 hours prior to test initiation.

Study type:

laboratory study

Test type:

semi-static

Water media type:

freshwater

Type of sediment:

natural sediment

Limit test:

no

Duration:

10 d

Exposure phase:

total exposure duration

Post exposure observation period:

40- 52 CaCO3 (mg/L)

Test temperature:

23 - 25 °C

pH:

6.5 - 6.8

Dissolved oxygen:

4.3 - 8.4 mg/L

Salinity:

-

Ammonia:

-

Nominal and measured concentrations:

Nominal concentrations: 6.6, 14, 26, 52 and 100 mg/kg
Mean measured sediment concentrations: 6.9, 15, 27, 50 and 100 mg/kg

Details on test conditions:

TEST SYSTEM
- Test container (material, size): 300-mL glass beakers
- Sediment volume: 100 mL
- Weight of wet sediment with and without pore water: (approximately 4-cm layer) of sediment (equivalent to 151 g wet weight per vessel or 103 g dry weight per vessel)
- Overlying water volume: 275 mL


EXPOSURE REGIME
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 10 (Eight replicates (A - H) were used to evaluate the biological response of the test organisms. The remaining two (I and J) replicates were maintained for the purpose of chemical analysis.)
- No. of replicates per control / vehicle control: 10 (Eight replicates (A - H) were used to evaluate the biological response of the test organisms. The remaining two (I and J) replicates were maintained for the purpose of chemical analysis.)


RENEWAL OF OVERLYING WATER
- Details on volume additions: the overlying water was renewed by adding two volume additions (i.e., 350 mL) per test vessel per day using an intermittent delivery system in combination with a calibrated water-distribution system
- Flow-rate: The water delivery system cycled approximately 7 times per day, providing approximately two volume additions per vessel every 24 hours.

OVERLYING WATER CHARACTERISTCS
- Type of water: Laboratory well water. The water used during the definitive exposure was characterized as having total hardness and total alkalinity ranges as calcium carbonate (CaCO3) of 36 to 40 and 22 to 26 mg/L, respectively, a pH range of 6.5 to 7.2, and a specific conductance range of 190 to 210 μmhos/cm.

SOURCE OF NATURAL SEDIMENT
- Location and description of sampling site: The sediment used during this study was collected from Glen Charlie Pond, Wareham, Massachusetts. Prior to use and characterization, the sediment was wet pressed through a 2.0-mm sieve to remove large particles. The sediment used in this study was characterized by Agvise Laboratories, Northwood, North Dakota, as having a percent organic carbon of 2.7%, a particle size distribution of 90% sand, 5% silt and 5% clay, a pH of 5.1 and a percent moisture at 1/3 bar (water holding capacity) of 10.8%.



OTHER TEST CONDITIONS
- Photoperiod: 16 hours light and 8 hours
- Light intensity: 390 to 590 lux

EFFECT PARAMETERS MEASURED: mortality and abnormal behavior at 24-hour intervals

VEHICLE CONTROL PERFORMED: yes

Duration:

10 d

Dose descriptor:

LC50

Effect conc.:

> 100 mg/kg sediment dw

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

act. ingr.

Basis for effect:

mortality

Duration:

10 d

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/kg sediment dw

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

act. ingr.

Basis for effect:

mortality

Results:

Based on Mean Measured Sediment Concentrations (mg/kg)
Endpoint	Midge Survival	Midge Growth
Lowest-Observed-Effect Concentration (LOEC)	> 100	> 100
No-Observed-Effect Concentration (NOEC)	100	100
LC/EC50 (95% Confidence Intervals)	> 100 (NAa)	> 100 (NA)

a) NA = Not Applicable. LC/EC value was empirically estimated, therefore, corresponding 95% confidence

intervals could not be calculated.

PROTOCOL DEVIATIONS

1. The protocol states that the overlying water pH will range from 6.8 to 7.5.

Characterization of the well water on 29 August 2007 yielded a pH measurement of 6.5.

Based on acceptable survival and growth in the controls, this deviation from the typical

overlying water pH range did not have a negative impact on the results or interpretation

of the study.

2. The protocol states that the test temperature will be maintained at 23 ± 1 ºC. During this

study, temperatures measured in the test vessels ranged from 22 to 24 ºC, except for four

days: 21, 24, 25 and 26 August 2007. The maximum temperature of the deviations was

25 ºC. Based on acceptable survival and growth in the controls, this deviation did not

have a negative impact on the results or interpretation of the study.

Reference 2

Endpoint:

sediment toxicity: short-term

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:

EPA OPPTS 850.1740 (Whole Sediment Acute Toxicity of Invertebrates, marine)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
The TGAS coded AE1170437 used at the initiation of this study includes multiple isomers, including the isomers AE1170437 (principle active substance) and AE1170438 (active isomer of the principle active substance). Since the biological activity of AE1170438 is similar to AE1170437, both are regarded as active substances in the TGAS. The TGAS contains 95% (94.5%) to 100% AE1170437 and, 0 % to 5 % (5.3 %) AE1170438. In order to distinguish between the single diastereomer AE1170437, and the TGAS containing both AE1170437 and AE1170438, a new BCS code, BCS-AA10717, has been designated for the TGAS mixture of stereoisomers. All references to the technical active substance and analytical results as AE1170437 are equivalent to the newly established TGAS: BCS-AA10717

Analytical monitoring:

yes

Vehicle:

yes

Test organisms (species):

Leptocheirus plumulosus

Details on test organisms:

TEST ORGANISM
- Common name: Estuarine Amphipods
- Source: Springborn Smithers culture
- Age of animals at beginning of exposure: juvenile amphipods, size range: 0.71 to 1.0 mm

Study type:

laboratory study

Test type:

semi-static

Water media type:

saltwater

Type of sediment:

natural sediment

Limit test:

no

Duration:

10 d

Exposure phase:

total exposure duration

Test temperature:

24 - 26 °C

pH:

7.6 - 8.4

Dissolved oxygen:

4.7 - 6.9 mg/L

Salinity:

20‰

Nominal and measured concentrations:

Nominal sediment concentrations: 5.3, 11, 21, 42, 85 and 170 mg/kg
Mean measured sediment concentrations: 5.7, 12, 26, 40, 110 and 180 mg/kg

Details on test conditions:

TEST SYSTEM
- Test container (material, size): 1000-mL glass beakers
- Sediment volume: 175 mL (approximately 2-cm layer) of sediment
- Overlying water volume: and 725 mL of overlying water



EXPOSURE REGIME
- No. of organisms per container (treatment): 20
- No. of replicates per treatment group: 9
- No. of replicates per control / vehicle control: 9
- Feeding regime: not fed


OVERLYING WATER CHARACTERISTCS
- Type of water: Natural, filtered seawater (salinity adjusted with laboratory well water)
Salinity: 20‰
pH: 8.1

SOURCE OF NATURAL SEDIMENT
- Location and description of sampling site: Natural marine sediment, collected from Little Harbor Beach, Wareham, Massachusetts
percent organic carbon: 3.7%
particle size distribution: 80% sand, 10% silt, and 10% clay
pH: 8.2
percent moisture (1/3 bar): 46.2%

OTHER TEST CONDITIONS
- Photoperiod: 24 hours light
- Light intensity: 500 to 840 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortility and behaviour

VEHICLE CONTROL PERFORMED: yes

Duration:

10 d

Dose descriptor:

NOEC

Effect conc.:

>= 180 mg/kg sediment dw

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

act. ingr.

Basis for effect:

mortality

Duration:

10 d

Dose descriptor:

LC50

Effect conc.:

> 180 mg/kg sediment dw

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

act. ingr.

Basis for effect:

mortality

Based on mean measured sediment concentrations and amphipod survival data, the following results were generated from this study:

Lowest-Observed-Effect Concentration (LOEC)	> 180 mg/kg
No-Observed-Effect Concentration (NOEC)	180 mg/kg
LC50 (95% confidence intervals)	> 180 (NAa) mg/kg

a) NA = Not Applicable. LC50 value was empirically estimated, therefore,

corresponding 95% confidence intervals could not be calculated.

Description of key information

Acute toxicity to sediment organisms is not expected.

Additional information

Information about sediment toxicology is not required under Regulation (EC) No 1907/2006 within this tonnage band but to complete the data set additional informations about sediment organisms are provided.

Two acute studies on sediment dwelling organisms are available,one with a freshwater and one with saltwater organisms according to EPA guidelines. Chironomus tentans was tested with natural sediment spiked with the test substance. The resulting NOEC (10d) was >100 mg/kg dw. The second study was conducted with the saltwater species Leptocheirus plumulosus in natural sediment and resulted in a LC50 of > 180 mg/kg dw.

The test substance shows no acute toxicity to sediment organisms.