N-phenylprop-2-enamide

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

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 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

April 13, 2004

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

December 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: At the end of the exposure period, the replicates were pooled at each concentration before sampling.
- Sampling method:
Frequency at t=0 h and t=48 h
Volume 1.5 mL from the approximate centre of the test vessels
- Sample storage conditions before analysis: Samples were stored in a freezer until analysis at the analytical laboratory of the Test Facility.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
The batch of CH03543 tested was a white powder with a purity of 99.3% and completely soluble in test medium at the concentrations tested.

Preparation of test solutions started with a test solution of 100 mg/L (combined limit/range-finding test) or 220 mg/L (final test) applying treatment with ultrasonic waves for 10 minutes followed by magnetic stirring for a maximum of 20 minutes to accelerate dissolution of the test item in medium. Lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium. All test solutions were clear and colorless at the end of the preparation procedure.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Strain/clone: In-house laboratory culture with a known history.
- Justification for species other than prescribed by test guideline: This system has been selected as an internationally accepted invertebrate species.
- Source: In-house laboratory culture with a known history.
- Age of parental stock (mean and range, SD): <4 weeks
- Feeding during test: no
- Food type: /
- Amount: /
- Frequency: /

ACCLIMATION
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: Daily, a suspension of fresh water algae

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

180mg/l (expressed as CaCO3)

Test temperature:

18.9-19.6°C

pH:

7.7-7.9

Dissolved oxygen:

9.4mg/l at the end of the test

Nominal and measured concentrations:

nominal: 10, 22, 46, 100 and 220 mg/L
measured 0h: not detected (nominal: 0 mg/L); 104 mg/L (nominal 100 mg/L); 223 mg/L (nominal 220 mg/L)
measured 48h: not detected (nominal: 0 mg/L); 101 mg/L (nominal 100 mg/L); 220 mg/L (nominal 220 mg/L)

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL, all-glass
- Type (delete if not applicable): static
- Aeration: No aeration of the test solutions.
- No. of organisms per vessel: 5 per vessel containing 80 mL of test solution
- No. of vessels per concentration (replicates): 4 for the control and the highest test concentration.
2 per intermediate test concentration.
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
M7, as prescribed by Dr. Elendt-Schneider (Elendt, B.-P., 1990: Selenium deficiency in Crustacea. An ultrastructural approach to antennal damage in Daphnia magna Straus. Protoplasma 154, 25-33).

Composition of medium M7:
Adjusted ISO medium: the following chemicals (analytical grade) are dissolved in tap water purified by Reverse Osmosis (RO-water, GEON Waterbehandeling, Berkel-Enschot, The Netherlands):
Macro salts: CaCl2.2H2O 211.5 mg/L
MgSO4.7H2O 88.8 mg/L
NaHCO3 46.7 mg/L
KCl 4.2 mg/L
Medium M7: trace elements, macronutrients and vitamins are added to freshly prepared ISO medium to reach the following concentrations:
Trace elements:
B 0.125 mg/L
Fe 0.05 mg/L
Mn 0.025 mg/L
Li, Rb and Sr 0.0125 mg/L
Mo 0.0063 mg/L
Br 0.0025 mg/L
Cu 0.0016 mg/L
Zn 0.0063 mg/L
Co and I 0.0025 mg/L
Se 0.0010 mg/L
V 0.0003 mg/L
Na2EDTA.2H2O 2.5 mg/L
Macro nutrients:
Na2SiO3.9H2O 10.0 mg/L
NaNO3 0.27 mg/L
KH2PO4 0.14 mg/L
K2HPO4 0.18 mg/L
Vitamins: Thiamine 75.0 µg/L
B12 1.0 µg/L
Biotin 0.75 µg/L
The hardness: 180 mg/L expressed as CaCO3 and the pH: 7.7 ± 0.3.


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 0 hours photoperiod daily
- Light intensity: 0

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Immobility (including mortality) At 24 hours and at 48 hours.
pH and Dissolved oxygen At the beginning and at the end of the test, for the highest concentration and the control.
Temperature of medium Continuously in a temperature control vessel, beginning at the start of the test.


VEHICLE CONTROL PERFORMED: yes (medium)

RANGE-FINDING STUDY
- Test concentrations: 0.10, 1.00, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: combined limit/range-finding study

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 5% immobile

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 220 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 220 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

The actual responses of the reference test with K2Cr2O7 are within the ranges of the expected responses at the different concentrations.
24h EC50 = 0.99 mg/L (0.90 - 1.10 mg/L)
48 EC50 = 0.42 mg/L (0.32 - 0.56 mg/L)

Validity criteria fulfilled:

yes

Conclusions:

An OECD 202 test was performed to determine the aquatic toxicity of CH03543 to aquatic invertebrates. The 48h EC50 value was > 220 mg/L, the NOEC was 100 mg/L.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached Read-across document.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

April 13, 2004

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

December 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: At the end of the exposure period, the replicates were pooled at each concentration before sampling.
- Sampling method:
Frequency at t=0 h and t=48 h
Volume 1.5 mL from the approximate centre of the test vessels
- Sample storage conditions before analysis: Samples were stored in a freezer until analysis at the analytical laboratory of the Test Facility.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
The batch of CH03543 tested was a white powder with a purity of 99.3% and completely soluble in test medium at the concentrations tested.

Preparation of test solutions started with a test solution of 100 mg/L (combined limit/range-finding test) or 220 mg/L (final test) applying treatment with ultrasonic waves for 10 minutes followed by magnetic stirring for a maximum of 20 minutes to accelerate dissolution of the test item in medium. Lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium. All test solutions were clear and colorless at the end of the preparation procedure.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Strain/clone: In-house laboratory culture with a known history.
- Justification for species other than prescribed by test guideline: This system has been selected as an internationally accepted invertebrate species.
- Source: In-house laboratory culture with a known history.
- Age of parental stock (mean and range, SD): <4 weeks
- Feeding during test: no
- Food type: /
- Amount: /
- Frequency: /

ACCLIMATION
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: Daily, a suspension of fresh water algae

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

180mg/l (expressed as CaCO3)

Test temperature:

18.9-19.6°C

pH:

7.7-7.9

Dissolved oxygen:

9.4mg/l at the end of the test

Nominal and measured concentrations:

nominal: 10, 22, 46, 100 and 220 mg/L
measured 0h: not detected (nominal: 0 mg/L); 104 mg/L (nominal 100 mg/L); 223 mg/L (nominal 220 mg/L)
measured 48h: not detected (nominal: 0 mg/L); 101 mg/L (nominal 100 mg/L); 220 mg/L (nominal 220 mg/L)

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL, all-glass
- Type (delete if not applicable): static
- Aeration: No aeration of the test solutions.
- No. of organisms per vessel: 5 per vessel containing 80 mL of test solution
- No. of vessels per concentration (replicates): 4 for the control and the highest test concentration.
2 per intermediate test concentration.
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
M7, as prescribed by Dr. Elendt-Schneider (Elendt, B.-P., 1990: Selenium deficiency in Crustacea. An ultrastructural approach to antennal damage in Daphnia magna Straus. Protoplasma 154, 25-33).

Composition of medium M7:
Adjusted ISO medium: the following chemicals (analytical grade) are dissolved in tap water purified by Reverse Osmosis (RO-water, GEON Waterbehandeling, Berkel-Enschot, The Netherlands):
Macro salts: CaCl2.2H2O 211.5 mg/L
MgSO4.7H2O 88.8 mg/L
NaHCO3 46.7 mg/L
KCl 4.2 mg/L
Medium M7: trace elements, macronutrients and vitamins are added to freshly prepared ISO medium to reach the following concentrations:
Trace elements:
B 0.125 mg/L
Fe 0.05 mg/L
Mn 0.025 mg/L
Li, Rb and Sr 0.0125 mg/L
Mo 0.0063 mg/L
Br 0.0025 mg/L
Cu 0.0016 mg/L
Zn 0.0063 mg/L
Co and I 0.0025 mg/L
Se 0.0010 mg/L
V 0.0003 mg/L
Na2EDTA.2H2O 2.5 mg/L
Macro nutrients:
Na2SiO3.9H2O 10.0 mg/L
NaNO3 0.27 mg/L
KH2PO4 0.14 mg/L
K2HPO4 0.18 mg/L
Vitamins: Thiamine 75.0 µg/L
B12 1.0 µg/L
Biotin 0.75 µg/L
The hardness: 180 mg/L expressed as CaCO3 and the pH: 7.7 ± 0.3.


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 0 hours photoperiod daily
- Light intensity: 0

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Immobility (including mortality) At 24 hours and at 48 hours.
pH and Dissolved oxygen At the beginning and at the end of the test, for the highest concentration and the control.
Temperature of medium Continuously in a temperature control vessel, beginning at the start of the test.


VEHICLE CONTROL PERFORMED: yes (medium)

RANGE-FINDING STUDY
- Test concentrations: 0.10, 1.00, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: combined limit/range-finding study

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

91 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 5% immobile

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 201 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 201 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

The actual responses of the reference test with K2Cr2O7 are within the ranges of the expected responses at the different concentrations.
24h EC50 = 0.99 mg/L (0.90 - 1.10 mg/L)
48 EC50 = 0.42 mg/L (0.32 - 0.56 mg/L)

Validity criteria fulfilled:

yes

Conclusions:

The EC50 for a structural analogue was determined at >201 mg/L

Description of key information

Read-across was performed from a structural analogue.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

201 mg/L