Propanenitrile, 2,3,3,3-tetrafluoro-2-(trifluoromethyl)-

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 May - 19 June 2020

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: 3M N.B # us278898.001-096
- Expiration date of the lot/batch: 10/30/2021
- Purity: 97.7%
- Physical state: White solid
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under storage conditions: Stable

Analytical monitoring:

no

Vehicle:

no

Details on preparation and application of test substrate:

- Method of mixing into soil: A 5 g/L stock solution was made in deionized reverse osmosis water. The test matrix components (5 g/L test substance stock solution, deionized water, and basic test substrate) were mixed evenly and distributed to 4 containers.
- Controls: One blank control of deionized water

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: Earthworm
- Source: Purchased from Jiang Su province Jurong Stock Farm (ID: EF-MKT-191212)
- Weight at test initiation (mean and range, SD): 300 - 600 mg.

ACCLIMATION
- Acclimation period: Quarentined and observed for 14 days
- Acclimation conditions: Earthworms were kept on a substarte of 50% by volume peat, 50% by volume cow manure at 20 ± 2 °C for 7 days prior to test. The test subjects were transfered to artifical test soil (without test substance) 24 hours prior to the test.

Study type:

laboratory study

Substrate type:

artificial soil

Remarks:

10% w/w Sphagnum peat, 20% w/w Kaolinite clay, 70% w/w silica sand

Limit test:

no

Total exposure duration:

14 d

Test temperature:

18.0 - 18.1°C

pH:

6.10 - 6.72

Moisture:

26.61-29.08 %

Details on test conditions:

TEST SYSTEM
- Test container (material, size): 1 liter glass bottles.
- Amount of soil or substrate: 750 grams wet weight of substrate
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: Four
- No. of replicates per control: Four

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Composition (if artificial substrate): Silica sand 70% w/w, Kaolinite clay 20% w/w, Spahnum peat 10% w/w
- Maximum water holding capacity (in % dry weigth): 58%
- Stability of test material in the medium: Stable

OTHER TEST CONDITIONS
- Photoperiod: Continuous illumination
- Light intensity: 719-761 lux

EFFECT PARAMETERS MEASURED : Mortality, form, behavior and body weight.

VEHICLE CONTROL PERFORMED: No

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2x
- Range finding study: Yes
- Test concentrations: 10, 100, 1000 mg/kg
- Results used to determine the conditions for the definitive study: Yes

Nominal and measured concentrations:

Nominal concentrations: 10, 22, 48.4, 106, 232, 514, 1129 mg/kg dry artifical soil weight.

Reference substance (positive control):

yes

Remarks:

Chloroacetamide

Key result

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

64.7 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% CI: 39.8 to 104 mg/kg dw

Duration:

7 d

Dose descriptor:

LC50

Effect conc.:

96.7 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% CI: 45.2 to 207 mg/kg dw

Details on results:

- Mortality at end of exposure period: See Table 1
- Changes in body weight of live adults at end of exposure period: 10.68±2.49% (blank control), 11.14±0.97% (10 mg/kg), 2.94±6.86% (22 mg/kg), -13.37±12.03% (48.4 mg/kg), -15.6±24.94 (106 mg/kg). At 232, 514 and 1129 mg/kg, 100% mortality seen.
- Morphological abnormalities: No abnormalities observed at either 7 or 14 day exposure for the surviving worms in any treatment groups.
- Behavioural abnormalities: No adverse behavioral effects observed at either 7 or 14 day exposure for the surviving worms in any treatment groups.

Results with reference substance (positive control):

14 day LC50 = 21.1 mg/kg (95% CI: 18.3-24.4 mg/kg) for chloroacetamide in earthworms from the same batch.

Reported statistics and error estimates:

Data was analyzed using Toxcalc v5.0.32 to calculate the 7 and 14 day LC50 values with 95% confidence limits.

Table 1. Mortality of E. fetida exposed to the test substance and controls after 7 and 14 days of exposure.

Duration (d) and test concentration	# of Earthworms	# dead worms (Rep A)	# dead worms (Rep B)	# dead worms (Rep C)	# dead worms (Rep D)	Total	Mortality (%)
7 d (Blank)	40	0	0	0	0	0	0
14 d (Blank)	40	0	0	0	0	0	0
7 d (10 mg/L)	40	0	0	0	0	0	0
14 d (10 mg/L)	40	0	0	0	0	0	0
7 d (22 mg/L)	40	0	0	0	0	0	0
14 d (22 mg/L)	40	1	2	2	3	8	20.0
7 d (48.4 mg/L)	40	3	4	4	2	13	32.5
14 d (48.4 mg/L)	40	3	4	5	3	15	37.5
7 d (106 mg/L)	40	1	4	2	3	10	25.0
14 d (106 mg/L)	40	3	6	7	5	21	52.5
7 d (232 mg/L)	40	10	10	10	10	40	100
14 d (232 mg/L)	40	/	/	/	/	-	-
7 d (514 mg/L)	40	10	10	10	10	40	100
14 d (514 mg/L)	40	/	/	/	/	-	-
7 d (1129 mg/L)	40	10	10	10	10	40	100
14 (1129 mg/L)	40	/	/	/	/	-	-

/ : no surviving earthworms,

- : not applicable

Validity criteria fulfilled:

yes

Remarks:

<10% mortality in controls (0%)

Conclusions:

14 day LC50 of 64.7 mg/kg dw (OECD 207) in Eisenia fetida.
7 day LC50 of 96.7 mg/kg dw (OECD 207) in Eisenia fetida.

Executive summary:

The 14 day LC50 of Heptafluoropropylamide to Eisenia fetida was determined according to OECD 207 guidelines. In the definitive test, nominal concentrations of 10, 22, 48.4, 106, 232, 514, 1129 mg/kg and a blank control, were run using 10 animals per tank, with four replicates per tank. A 14 day LC50 of 64.7 mg/kg (dry artificial soil weight) were found for Eisenia fetida.

The study was well-documented, followed an international standard method and was GLP compliant. The study is considered reliable without restrictions. The results from this study are considered suitable for Risk Assessment, Classification and Labeling, and PBT Analysis

Description of key information

14 day LC50 of 64.7 mg/kg dw (OECD 207) in Eisenia fetida.

7 day LC50 of 96.7 mg/kg dw (OECD 207) in Eisenia fetida.

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:

64.7 mg/kg soil dw

Additional information

The 14 day LC50 of Heptafluoropropylamide to Eisenia fetida was determined according to OECD 207 guidelines. In the definitive test, nominal concentrations of 10, 22, 48.4, 106, 232, 514, 1129 mg/kg and a blank control, were run using 10 animals per tank, with four replicates per tank. A 14 day LC50 of 64.7 mg/kg (dry artificial soil weight) were found for Eisenia fetida.

The study was well-documented, followed an international standard method and was GLP compliant. The study is considered reliable without restrictions. The results from this study are considered suitable for Risk Assessment, Classification and Labeling, and PBT Analysis