cis-4-[3-(p-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06.04.- 13.06.2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EPA OPP 72-1 (Fish Acute Toxicity Test)

Version / remarks:

1982

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Version / remarks:

1996

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Principles of method if other than guideline:

92/69/EEC, Annex V, C1

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Test organisms (species):

Pimephales promelas

Details on test organisms:

TEST ORGANISM
- Common name: Fathead minnow
- Source: Osage Catfisheries, Inc., Osage Beach, MO 65065, USA
- Age at study initiation: Approx. 20 months;
hatching date: August 2003;
arrival at testing facility: 23.06.2004
- Length at study initiation; mean: 4.4 cm (4.1 – 4.9 cm)
- Weight at study initiation; mean: 0.64 g (0.50 – 0.87 g)

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions: same as test
- Type and amount of food during acclimation: Commercial fish diet „Tetramin“, supplier Tetra-Werke, Melle, Germany, ad libitum, additionally generally on workdays live brine shrimp (artemia).
- Feeding frequency during acclimation: Yes, withdrawal of food during the last day before start of exposure
- Health during acclimation (any mortality observed): no abnormalities

Test type:

static

Water media type:

freshwater

Total exposure duration:

96 h

Hardness:

Approx. 1 mmol/L = 100 mg/L CaCO3

Test temperature:

approx. 23°C

pH:

7.0 – 7.7

Dissolved oxygen:

> 80% saturation

Conductivity:

Approx. 250 μS/cm (at 25°C)

Nominal and measured concentrations:

Nominal concentrations: 0, 0.5, 1.0, 2.2, 5.0, 10 mg/L;
mean analytically determined concentrations: 0, 0.3, 0.7, 1.4, 3.4, 7.4 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass aquaria (30 cm long, 22 cm wide, 24 cm high)
- fill volume: 10 L
- Aeration: None over the first 48 hours, slight aeration during the last days of exposure, since the oxygen content after 48 hours was decreased to 44 - 50% saturation. The concentration of the test substance was not decreased by aeration.
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- Biomass loading rate: 0.6 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source: Non chlorinated charcoal filtered tap water (Frankenthal, Germany), mixed with deionized water, aerated
- Ca/mg ratio: 40/5 mg/L
- Acid capacity: Approx. 2.5 mmol/L

OTHER TEST CONDITIONS
- Adjustment of pH: was adjusted to pH 7.0 twice daily (using HCl (10%))
- Photoperiod: 16 hours light, 8 hours dark
- Light intensity: Approx. 36 - 191 Lux (the light intensity is determined in regular intervals at the surface of the aquaria)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Symptoms and lethality:
The fish were observed for survival and toxic signs (changes in appearance, swimming behaviour and behaviour in comparison to the control group) within 1 hour after start of exposure and 4, 24, 48, 72 and 96 hours after start of exposure. Fish were considered dead if there was no visible movement and no reaction after touching. Dead fish were removed from the test vessels.

- Water parameter:
Temperature and oxygen content were measured in each test vessel within 1hour after start of exposure and after 24, 48, 72 and 96 hours. The pH value was measured in each test vessel within 1 hour after start of exposure and then twice daily followed by an adjustment to pH 7.0.

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 - < 2.2 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1.7 - < 3.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

Analytical measurements: The analytically detected concentrations were initially in the range of 84.8% - 101.2% and after 96 hours 25.1% - 57.5% of the nominal concentrations. The decrease was most likely due to uptake of the test item by the fish. The biological results are therefore based on the mean (from start and end) analytically detected concentrations.

Biological results: Fenpropimorph caused mortality to the Fathead minnow at concentrations of ≥ 0.58 mg a.s./L. Behavioural symptoms (tottering) were monitored in the 1.21 mg a.s./L concentration after 96 hours of exposure.

Sublethal observations / clinical signs:

The following effect concentrations (mg/L) were obtained based on nominal concentrations:

	Observation time (hours after start of exposure)
	24 hours	48 hours	72 hours	96 hours
LC0	1.0	1.0	0.5	0.5
LC50 (95% confidence limits)	2.4 -	2.3 -	2.3 1.7 - 3.3	2.3 1.7 - 3.3
LC100	5.0	5.0	5.0	5.0
NOEC	0.5	0.5	0.5	0.5

The following effect concentrations (mg/L) were obtained based on mean analytically determined concentrations:

	Observation time (hours after start of exposure)
	24 hours	48 hours	72 hours	96 hours
LC0	0.6	0.6	0.4	0.4
LC50 (95% confidence limits)	1.3 -	1.3 -	1.4 1.0 - 2.2	1.4 1.0 - 2.2
LC100	3.6	3.6	3.6	3.6
NOEC	0.4	0.4	0.4	0.4

Explanation:
LC0 = maximum concentration causing no mortality within the period of the test
LC50 = median lethal concentration
LC100 = minimum concentration causing 100% mortality within the period of the test
NOEC = no observed effect concentration
- = no data

 

 

Acute toxicity (96 h) of Fenpropimorph on Fathead minnow (Pimephales promelas)
Concentration [mg a.s./L] nominal	Control	0.5	1.0	2.2	5.0	10.0
Concentration [mg a.s./L] measured	Control	0.37	0.58	1.21	3.56	8.62
	Control
Mortality [%]	0	0	10	30	100	100
Symptoms	none	none	none	T	--	--

Symptoms: T = tottering

Conclusions:

Based on the mean analytically detected concentrations the median lethal concentration LC50 of fenpropimorph on the Fathead minnow was 1.4 mg a.s./L. The NOEC was determined to be 0.37 mg a.s./L.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

25.- 29.10.1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

EPA OPP 72-1 (Fish Acute Toxicity Test)

Version / remarks:

EPA guideline "Pesticide Assessment Guidelines, subdivision E, Hazard Evaluation Wildlife and Aquatic Organisms (U.S.) Environmental Protection Agency, Washington DC, para. 72-1. P. 66, October 1982 and the (U.S.) EPA—SEP (Standard Evaluation Procedure) No. 540/9-85-006, June 1985.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Fenpropimorph (Reg. No. 108 406), batch no. N 103, purity: 96.6%

Analytical monitoring:

yes

Test organisms (species):

Lepomis macrochirus

Details on test organisms:

TEST ORGANISM
- Common name: Bluegill
- Source: Osage catfisheries INC. Lake Road 54-56; Rt 4 Box 1500; Osage Beach, Missouri 65065
- Length at study initiation: mean length: 7.79 cm; Range: 7.0 - 8.5 cm
- Weight at study initiation: mean wet weight: 5.13 g; Range: 3.2 - 6.9 g

ACCLIMATION
- Acclimation conditions: same as test
- Type and amount of food during acclimation: "TETRA MIN" standard feed for aquarium fish TETRA - WERKE, MELLE, FRG, ad libitum; and on workdays generally additionally frozen and/or live brine shrimp (artemia)
- Feeding frequency during acclimation: Yes, withdrawal of food day before and during exposure
- Health during acclimation (any mortality observed): no physical adnormalities observed, mortality during the last 7 days: 0.3%

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

About 2.5 mmol/l (= about 250 mg/l CaC03)

Test temperature:

22.0 - 23.4 °C

pH:

During adaptation period adjusted to approx. pH 7 with HCl (6%)

Dissolved oxygen:

> 60% of maximum saturation

Nominal and measured concentrations:

Nominal concentrations: control, 0.63, 1.00, 1.60, 2.50, 4.00, 6.30, 10.00 mg/l;
Mean measured concentartions: in the range of 52% to 80% of the nominal concentration.

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass aquaria with a stainless steel frame (80 x 35 x 46 cm)
- fill volume: 100 liters (water depth about 40 cm)
- Aeration: None during the initial two days: thereafter slight aeration since the content of dissolved oxygen in the test medium was too low.
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: approx. 0.5 g/L

TEST MEDIUM / WATER PARAMETERS
- Source: Municipal water of the city of Frankenthal, not chlorinated and passed through a charcoal filter, aerated
- Total hardness: about 2.5 mmol/l (= about 250 mg/l CaCO3)
- Acid capacity : about 5.5 mmol/l
- Ca content : about 90 mg/l
- Mg content : about 10 mgll
- pH : adjusted twice daily to approx. pH 7 with HCl (6%)

The test water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the technical services of BASF Aktiengesellschaft as well as for presence of microbes by a contract laboratory.

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light, 8 hours dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): after 1, 4, 24, 48, 72 and 96 hour for LC50 and NOEC

RANGE FINDING STUDY:
Concentrations were fixed bsed on the result of acute toxicity study in other fish species (LC 50 rainbow trout after 96 h: > 4.0 < 6.3 mg/l)

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

0.263 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1.744 - < 3.052 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

Table 8.2/2       Acute toxicity (96 h) of Fenpropimorph on bluegill sunfish (Lepomis macrochirus)
Concentration [mg a.s./L] nominal	Control	0.63	1.0	1.6	2.5	4.0	6.3	10.0
Concentration [mg a.s./L] measured	Control	0.263	0.477	1.052	1.744	3.052	--	--
	Control
Mortality [%]	0	0	0	0	0	100	100	100
Symptoms	none	none	D, N	D, N	D, N	--	--	--

Symptoms: D = swimming near the bottom; N = narcotic-like state

 

Conclusions:

Based on the mean analytically detected concentrations of unfiltered samples the median lethal concentration LC50 of Fenpropimorph on bluegill sunfish was >1.74 mg a.s./L and < 3.05 mg a.s./L. The NOEC was determined to be 0.263 mg a.s./L.

Description of key information

LC50 for Lepomis macrochirus: 1.74 mg/L < LC50 < 3.05 mg/L
LC50 for Pimapheles promelas:  1.0 mg/L < LC50 < 2.2 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

1.4 mg/L

Additional information

A considerable amount of data is available for the assessment of potential risks of fenpropimorph on short-term toxicity to fish.
Fenpropimorph is toxic in standard acute studies with LC/EC50 values above 1 mg/L