N-ethyl-p-methoxy-α-methylphenethylamine

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

of read across substance

Justification for type of information:

Data for the target chemical is summarized based on the structurally similar read across chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

WoE report is based on two short term toxicity study of fish for the test chemical :
1.Determination of the inhibition of the mobility of Daphnids was carried out with the test chemical according to OECD Guideline 202.
2. EC50 value of test material was measured on crustacean Daphnia magna for 48 hrs.

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material (IUPAC name): 2-(N-ethylamino)-1-(4-methoxyphenil propane)
- IUPAC name: 2-(N-ethylamino)-1-(4-methoxyphenil propane)
- Molecular formula: C12H19NO
- Molecular weight: 193.2881 g/mol
- Smiles notation: CCNC(C)Cc1ccc(OC)cc1
- InChl: 1S/C12H19NO/c1-4-13-10(2)9-11-5-7-12(14-3)8-6-11/h5-8,10,13H,4,9H2,1-3H3
- Substance type: Organic

Analytical monitoring:

not specified

Details on sampling:

2.- Method of confirmation of identity of measured compound: UV–visible spectrophotometer, UV mini 1240

Vehicle:

not specified

Details on test solutions:

1. PREPARATION AND APPLICATION OF TEST SOLUTION
The stock solution 150.0 mg/L was prepared by dissolving white powder in reconstituted water. The solution was kept in ultrasonic bath for 20 min. The test solutions of required concentrations were prpared by mixing the stock solution of the test sample in reconstituted water.
- Controls: Reconstituted water as specified in OECD 202, used as a control and for sample dilution.

Test organisms (species):

Daphnia magna

Details on test organisms:

1.TEST ORGANISM
- Common name: Water flea
- Strain/clone: Straus
- Source: Own breeding at University of Chemistry and Technology, Prague
- Age: Young daphnids, aged less than 24 hours used at the start of the test and they should not be first brood progeny.
- Feeding during test : Without feeding

ACCLIMATION
- Acclimation period: No data
- Acclimation conditions (same as test or not): No data
- Type and amount of food: No data
- Feeding frequency: No data
- Health during acclimation (any mortality observed): No data

QUARANTINE (wild caught)
- Duration: No data
- Health/mortality: No data

2.- Common name: water flea
- Source: National Institute for Environmental Studies (NIES), Tsukuba, Japan
- Age at study initiation (mean and range, SD):<24 hrs (neonates)

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

2.~100 mg/l as CaCO3

Test temperature:

1) 20 °C ± 1 °C

pH:

1. Sample at concentration 150 mg/L: pH = 7.3 changed to pH = 7.2 during the test, Control: pH = 7.8 changed to pH = 7.6 during the test.
2. 7.45 ± 0.05

Dissolved oxygen:

1.Higher than 8.1 mg/L both in the control and the sample.

Nominal and measured concentrations:

1) 0, 30.0, 45.0, 67.5, 100.0 and 150.0 mg/L.

Details on test conditions:

1.TEST SYSTEM
- Test vessel: 50 ml glass vessel
- Material, size, headspace, fill volume: 25 ml
- Aeration: no data
- No. of organisms per vessel: 5 pieces
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): No data
- No. of vessels per vehicle control (replicates): No data
- Biomass loading rate: No data

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Natural water (surface or ground water), reconstituted water or dechlorinated tap water are acceptable as culturing and dilution water if D. magna survives in it for the duration of the culturing, acclimation and testing without showing signs of stress. Waters in the range pH 6 to pH 9, with hardness between 140 mg/l and 275 mg/l (as CaCO3) are recommended.As an example, the preparation of dilution water meeting the requirements is described below.Dissolve known quantities of reagents in water. The dilution water prepared shall have a pH of 7.8 ± 0.5, a hardness of (225 ± 50) mg/l (expressed as CaCO3), a molar Ca + Mg ratio close to 4 + 1 and a dissolved oxygen concentration above 7 mg/l.

Prepare the solutions specified below:
- Calcium chloride solution: Dissolve 117.6 g of calcium chloride dihydrate (CaCl2.2H2O) in water (4.2) and make up to 1 l with water (4.2).
- Magnesium sulfate solution: Dissolve 49.3 g of magnesium sulfate heptahydrate (MgSO4.7H2O) in water (4.2) and make up to 1 l with water (4.2).
- Sodium bicarbonate solution: Dissolve 25.9 g of sodium bicarbonate (NaHCO3) in water (4.2) and make up to 1 l with water (4.2).
- Potassium chloride solution: Dissolve 2.3 g of potassium chloride (KCI) in water (4.2) and make up to 1 l with water (4.2).

Mixing
Mix 2.5 ml of each of the four solutions and make up to 1 l with water.
The dilution water shall be aerated until the dissolved oxygen concentration has reached saturation and the pH has stabilized. If necessary, adjust the pH to 7.8 ± 0.5 by adding sodium hydroxide (NaOH) solution or hydrochloric acid (HCI). The dilution water prepared in this way shall not be further aerated before use.

- Sodium hydroxide solution, e.g. [NaOH] : 1 mol/l.
- Hydrochloric acid, e.g. [HCl] : 1 mol/l.

OTHER TEST CONDITIONS
- Adjustment of pH: Without adjustment
- Photoperiod: No - Darkness

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : EC50 was calculated using non linear regression by the software Prism 4.0.

2. Test vessel: 50 ml Beaker
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 40ml
- Aeration: before the test start
- Renewal rate of test solution (frequency/flow rate): The medium was renewed three times a week ( during culture condition)
- No. of vessels per concentration (replicates): 4 replicates


OTHER TEST CONDITIONS
- Adjustment of pH: Yes with the help of NaOH and HCL
- Photoperiod: 16 h light: 8 h dark photoperiod

TEST CONCENTRATIONS
- Test concentrations: 851.984 -1019.338 mg/l

Reference substance (positive control):

yes

Remarks:

Potassium dichromate (K2Cr2O7) for read across 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

100.8 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Read across 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

943.26 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Read across 2

Results with reference substance (positive control):

1.- Results with reference substance valid
- 24h EC50 = 0.73 mg/L K2Cr2O7

Validity criteria fulfilled:

not specified

Conclusions:

The test chemical 4-Methoxybenzylamine is not likely to be toxic to Daphnia magna atleast in the dose range of 100.8-943.26 mg/l

Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the short term toxicity to aquatic invertebrates of the test chemical 2-(N-ethylamino)-1-(4-methoxyphenil propane) (14367 -46 -5).The studies are as mentioned below:

1.Determination of the inhibition of the mobility of Daphnids was carried out with the test materialaccording to OECD Guideline 202.

The stock solution 150.0 mg/L was prepared by dissolving white powder in reconstituted water. The solution was kept in ultrasonic bath for 20 min. The test solutions of required concentrations were prpared by mixing the stock solution of the test sample in reconstituted water.The test substance was tested at the concentrations 0, 30.0, 45.0, 67.5, 100.0 and 150.0 mg/L.The test was performed under static conditions in a fresh water system at a temperature of 20 °C± 1 °C. EC50 was calculated using non linear regression by the software Prism 4.0.

The median effective concentration (EC50) for the test substance, test material, in Daphnia magna was determined to be 100.8 mg/L for immobilisation effects with 95% CI of 94.7 to 107.4 mg/L.

2.Short term toxicity to aquatic invertebrates was performed in Daphnia magna for 48 hrs. The young daphnids were obtained from continuous cultures in 1 liter glass beakers at 21 ± 0.3 degree C, in dechlorinated and conditioned tap water, the medium was renewed in three weeks and daphnids were fed daily with the green alga Selenastrum capricornutum. The pH of test solution was adjusted to 7.45 ± 0.05 with HCL and NaOH. The concentrations of the resultant solutions were checked before and after (48 h) exposure using a UV–visible spectrophotometer.

As the experiment starts neonate were placed in 50 ml of beaker with 40 ml of test solution. All experiment was made in four replicates and performed at 21 ± 0.3 degree C under 16 h light: 8 h dark photoperiod.

Immobility was observed after 24 and 48 hrs and EC 50 value was calculated. After the experiment the EC 50 value of test material for Daphnia magna was determined to be 943 mg/l in 48 hrs.

Thus, based on the above summarised studies, 2-(N-ethylamino)-1-(4-methoxyphenil propane) and it’s structurally and functionally similar read across substance, it can be concluded that effect concetration value is in the range 100.8 to 943.26 mg/L. Thus, comparing this value with the criteria of CLP regulation , 2-(N-ethylamino)-1-(4-methoxyphenil propane) cannot be classified for short term toxicity to aquatic invertebrates .Hence,based on the data available for the structurally and functionally similar read across, test chemical 2-(N-ethylamino)-1-(4-methoxyphenil propane) is not likely to be toxic atleast in the concentration range of 100.8 to 943.26 mg/L

.

Description of key information

Short-term toxicity to aquatic invertebrates:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the short term toxicity to aquatic invertebrates of the test chemical 2-(N-ethylamino)-1-(4-methoxyphenil propane) (14367 -46 -5).The studies are as mentioned below:

1.Determination of the inhibition of the mobility of Daphnids was carried out with the test materialaccording to OECD Guideline 202.

The stock solution 150.0 mg/L was prepared by dissolving white powder in reconstituted water. The solution was kept in ultrasonic bath for 20 min. The test solutions of required concentrations were prpared by mixing the stock solution of the test sample in reconstituted water.The test substance was tested at the concentrations 0, 30.0, 45.0, 67.5, 100.0 and 150.0 mg/L.The test was performed under static conditions in a fresh water system at a temperature of 20 °C± 1 °C. EC50 was calculated using non linear regression by the software Prism 4.0.

The median effective concentration (EC50) for the test substance, test material, in Daphnia magna was determined to be 100.8 mg/L for immobilisation effects with 95% CI of 94.7 to 107.4 mg/L.

2.Short term toxicity to aquatic invertebrates was performed in Daphnia magna for 48 hrs. The young daphnids were obtained from continuous cultures in 1 liter glass beakers at 21 ± 0.3 degree C, in dechlorinated and conditioned tap water, the medium was renewed in three weeks and daphnids were fed daily with the green alga Selenastrum capricornutum. The pH of test solution was adjusted to 7.45 ± 0.05 with HCL and NaOH. The concentrations of the resultant solutions were checked before and after (48 h) exposure using a UV–visible spectrophotometer.

As the experiment starts neonate were placed in 50 ml of beaker with 40 ml of test solution. All experiment was made in four replicates and performed at 21 ± 0.3 degree C under 16 h light: 8 h dark photoperiod.

Immobility was observed after 24 and 48 hrs and EC 50 value was calculated. After the experiment the EC 50 value of test material for Daphnia magna was determined to be 943 mg/l in 48 hrs.

Thus, based on the above summarised studies, 2-(N-ethylamino)-1-(4-methoxyphenil propane) and it’s structurally and functionally similar read across substance, it can be concluded that effect concetration value is in the range 100.8 to 943.26 mg/L. Thus, comparing this value with the criteria of CLP regulation , 2-(N-ethylamino)-1-(4-methoxyphenil propane) cannot be classified for short term toxicity to aquatic invertebrates .Hence,based on the data available for the structurally and functionally similar read across, test chemical 2-(N-ethylamino)-1-(4-methoxyphenil propane) is not likely to be toxic atleast in the concentration range of 100.8 to 943.26 mg/L

.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

943.26 mg/L

Additional information

Short-term toxicity to aquatic invertebrates:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the short term toxicity to aquatic invertebrates of the test chemical 2-(N-ethylamino)-1-(4-methoxyphenil propane) (14367 -46 -5).The studies are as mentioned below:

1.Determination of the inhibition of the mobility of Daphnids was carried out with the test materialaccording to OECD Guideline 202.

The stock solution 150.0 mg/L was prepared by dissolving white powder in reconstituted water. The solution was kept in ultrasonic bath for 20 min. The test solutions of required concentrations were prpared by mixing the stock solution of the test sample in reconstituted water.The test substance was tested at the concentrations 0, 30.0, 45.0, 67.5, 100.0 and 150.0 mg/L.The test was performed under static conditions in a fresh water system at a temperature of 20 °C± 1 °C. EC50 was calculated using non linear regression by the software Prism 4.0.

The median effective concentration (EC50) for the test substance, test material, in Daphnia magna was determined to be 100.8 mg/L for immobilisation effects with 95% CI of 94.7 to 107.4 mg/L.

2.Short term toxicity to aquatic invertebrates was performed in Daphnia magna for 48 hrs. The young daphnids were obtained from continuous cultures in 1 liter glass beakers at 21 ± 0.3 degree C, in dechlorinated and conditioned tap water, the medium was renewed in three weeks and daphnids were fed daily with the green alga Selenastrum capricornutum. The pH of test solution was adjusted to 7.45 ± 0.05 with HCL and NaOH. The concentrations of the resultant solutions were checked before and after (48 h) exposure using a UV–visible spectrophotometer.

As the experiment starts neonate were placed in 50 ml of beaker with 40 ml of test solution. All experiment was made in four replicates and performed at 21 ± 0.3 degree C under 16 h light: 8 h dark photoperiod.

Immobility was observed after 24 and 48 hrs and EC 50 value was calculated. After the experiment the EC 50 value of test material for Daphnia magna was determined to be 943 mg/l in 48 hrs.

Thus, based on the above summarised studies, 2-(N-ethylamino)-1-(4-methoxyphenil propane) and it’s structurally and functionally similar read across substance, it can be concluded that effect concetration value is in the range 100.8 to 943.26 mg/L. Thus, comparing this value with the criteria of CLP regulation , 2-(N-ethylamino)-1-(4-methoxyphenil propane) cannot be classified for short term toxicity to aquatic invertebrates .Hence,based on the data available for the structurally and functionally similar read across, test chemical 2-(N-ethylamino)-1-(4-methoxyphenil propane) is not likely to be toxic atleast in the concentration range of 100.8 to 943.26 mg/L

.