Potassium (R)-[(3-ethoxy-1-methyl-3-oxoprop-1-enyl)amino]phenylacetate

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

key study

Study period:

end on September 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study performed according to OECD guideline and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Potassium (R)-(4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-1-enyl)amino]acetate

EC Number:

273-992-8

EC Name:

Potassium (R)-(4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-1-enyl)amino]acetate

Cas Number:

69416-61-1

IUPAC Name:

potassium (4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-1-en-1-yl)amino]acetate

Details on test material:

- Name of test material (as cited in study report): D(-)-p-Hydroxyphenylglycine Dane Salt(K, Methyl)
- Substance type: monoconstituent substance
- Physical state: powder
- Stability under test conditions: stable (see analytical measurement)
- Storage condition of test material: At room temperature, protected from light

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Melting point: 421 - 432 °C
- Boiling point: 439°C (the sample decomposes)
- Vapour pressure: 8.64E-12 mmHg at 25°C
- Water solubility: not determined (form micelles in aqueous phases due to properties of surface tension)
- log Pow: LogKow < -2.3
- UV absorption: 224 nm, 276 nm

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 100 mg/L
- Sampling method: data not available
- Sample storage conditions before analysis: data not available

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION:
The test item was introduced into the test solution in one step.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain: Daphnia magna STRAUS (clone 5)
- Source: laboratory bred
- Age at study initiation: not older than 24h
- Method of breeding: data not available
- Feeding during test: no

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

none

Test conditions

Hardness:

data not available

Test temperature:

21.1 to 21.4 °C

pH:

t0: 9.04 (control) and 8.99 (100 mg/L)
t48: 9.02 (control) and 8.69 (100 mg/L)

Dissolved oxygen:

between 7.6 and 8.8 mg O2/L

Salinity:

not applicable (freashwater)

Nominal and measured concentrations:

nominal: 100 mg/L
measured: 111.4 mg/L at t0 and 113.6 mg/L at t48

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL carboys with glass stoppers made of glass
- Type: closed (stoppers made of glass were used in order to minimize losses due to evaporation)
- Aeration: test vessel was gently agitated
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
The stock solutions were individually prepared in ultrapure water.
Medium: dilution water according to Elendt M4.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16h of light and 8h of darkness
- Light intensity: data not available

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
The effect of the test item to the animals was examined by the determination of the swimming behaviour of the daphnia. For this purpose the respective test vessel was gently agitated. Daphnia showing no swimming within 15 sec. were considered as immobile. Moving of antenna was not considered as swimming.
The effect was determined at 24 and 48h.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: only one concentration
- Justification for using less concentrations than requested by guideline: limit test
- Range finding study
- Test concentrations: 0.0 (control), 1.0, 10, and 100 mg of the test item per litre of dilution water
- Results used to determine the conditions for the definitive study: the main test was performed as a limit-test using 100 mg/L as the sole test concentration as there was no toxicity up to that highest concentration within the screening-test.

Reference substance (positive control):

yes

Remarks:

potassium dichromate (prior to beginning of the test)

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks:

swimming behaviour

Remarks on result:

other: no effect observed

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks:

swimming behaviour

Remarks on result:

other: no effect observed

Effect concentrations 3

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks:

swimming behaviour

Details on results:

No immobilisation of the daphnia was observed at nominal concentrations up to 100 mg/L.

Results with reference substance (positive control):

The value of the EC50 (24h) was 1.06 mg/L potassium dichromate.
This value is in accordance with the recommendations given in OECD Guideline 202.

Reported statistics and error estimates:

not applicable

Any other information on results incl. tables

Table 1: results in the main test:

Concentration of the test item(mg/L)		Ratio immobilised Daphnia [%]		pH-Value		O2-Content [mg O2/L]		Temperature [°C]
		24h	48h	t0	48h	t0	48h	t0	48h
Control (0)		0 [0/20]	0 [0/20]	9.04	9.02	8.8	8.5	21.4	21.4
100		0 [0/20]	0 [0/20]	8.99	8.69	8.7	7.6	21.1	21.4

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

The criteria of validity of results given by the OECD Guideline 202 were kept within this study.

Conclusions:

48h-NOEC and EC50 > 100 mg/L

Executive summary:

The 48hr-acute toxicity of D(-)-p-Hydroxyphenylglycine Dane Salt (K, Methyl) toDaphnia magnawas studied under static conditions (OECD 202, GLP). Daphnids were exposed to 0 and 100 mg/L for 48hr. In order to investigate the influence of the test item towards the daphnia the swimming behaviour of the animals was recorded.

 

Under the conditions used for the test, no immobilisation of the daphnia was observed at nominal concentrations up to 100 mg/L. The following EC-values were calculated on basis of the nominal concentrations being tested:

	t24h	t48h
NOEC	>100 mg/L	>100 mg/L
LOEC	≥100 mg/L	≥100 mg/L
EC10	>100 mg/L	>100 mg/L
EC20	>100 mg/L	>100 mg/L
EC50	>100 mg/L	>100 mg/L
EC100	>100 mg/L	>100 mg/L

Within chemical analyses performed with the test solutions at t0 and t48h, it could be shown, that the test item remained stable in the aqueous phase. For this reason, the results of this test are based on the nominal concentrations tested.

  

Based on the results of this study, D(-)-p-Hydroxyphenylglycine Dane Salt (K, Methyl) would not be classified as harmful to Daphnia according to EU criteria.

This study is classified as acceptable and satisfies the guideline requirements for an acute toxicity study with freshwater invertebrates.