Amides, C18-unsatd., N-hydroxyethyl

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 based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

From August 27, 1996 to Septmeber 05, 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Read across study

Justification for type of information:

Refer to section 13 of IUCLID for details on the read-across justification.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

no

Details on sampling:

- Concentrations: 0.10, 0.18, 0.32, 0.56, 1.0, 1.8, 3.2, 5.6 and 10 mg/L
- Sample storage conditions before analysis: Ambient temperature (< 25 °C), 50% relative humidity, shielded from light; not necessarily in darkness.

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Direct dispersion in water
- Controls: Reconstituted water
- Chemical name of vehicle: Water
- Concentration of vehicle in test medium (stock solution): 10 mg/L
- Preparation of test solution: Direct dispersion in water: Test material (20 mg) was dispersed in approximately 15 mL of reconstituted water with the aid of ultrasonic disruption, heated to approximately 55 °C and then cooled to room temperature prior to the volume being adjusted to 2 L, to give the 10 mg/L test concentration from which dilutions were made to give the remainder of the test series.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Strain origin: IRCHA
- Age at study initiation (mean and range, SD): First instar
- Food type: Algae (predominantly Chlorella sp.)

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Remarks on exposure duration:

h

Hardness:

270 mg/L as CaCO3

Test temperature:

21°C

pH:

7.8 ± 0.2

Dissolved oxygen:

Reconstituted water was aerated until the dissolved oxygen concentration was approximately air-saturation value

Nominal and measured concentrations:

0.10, 0.18, 0.32, 0.56, 1.0, 1.8, 3.2, 5.6 and 10 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Fill volume: 250 mL containing 200 mL of test solution
- Aeration: No auxiliary aeration
- Type of flow-through (e.g. peristaltic or proportional diluter):
- Renewal rate of test solution: No
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): Two
- No. of vessels per vehicle control (replicates): Two


TEST MEDIUM / WATER PARAMETERS
- Type of water: Deionised water
- Composition:
CaCI2.2H2O: 11.76 g/L
MgS04.7H2O: 4.93 g/L
NaHCO3: 2.59 g/L
KCI: 0.23 g/L
- Conductivity: < 5 µS cm-1


OTHER TEST CONDITIONS
- Adjustment of pH: pH adjusted to 7.8 ± 0.2 with NaOH or HCl
- Photoperiod: 16 h light/8 h dark


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mobility measured at interval of 24 h


TEST CONCENTRATIONS
- Spacing factor for test concentrations: ca. 1.8
- Range finding study
- Test concentrations: 0.10, 0.18, 0.32, 0.56, 1.0, 1.8, 3.2, 5.6 and 10 mg/L
- Results used to determine the conditions for the definitive study: Immobility data

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: ± 0.4

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

1.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Table 1: Range finding study: Cumulative mortality data for Daphnia magna exposed for 48 h to Empilan CME

Concentration (mg/L)	Cumulative Mortality (initial population = 10)
	24 h	48 h
Control	0	0
0.10	0	0
0.20	0	0
1.0	0	0
2.0	0	0
10	10	10
20	10	10

Table 2: Cumulative immobilisation data for Daphnia magna exposed for 48 h to Empilan CME

Nominal concentration (mg/L)	Cumulative immobilised Daphnia (initial population: 10 per replicate)
	24 h				48 h
	R1	R2	Total	%	R1	R2	Total	%
Control	0	0	0	0	0	0	0	0
0.10	0	0	0	0	0	0	0	0
0.18	0	0	0	0	0	0	0	0
0.32	0	0	0	0	0	0	0	0
0.56	0	0	0	0	0	0	0	0
1.0	0	0	0	0	0	0	0	0
1.8	0	0	0	0	0	0	0	0
3.2	6	6	12	60	6	6	12	60
5.6	8	10	18	90	10	10	20	100
10	10	10	20	100	10	10	20	100

* R1 & R2 = replicates 1 & 2

Validity criteria fulfilled:

not specified

Remarks:

Dissolved O2 data (at the end of the test) not reported.

Conclusions:

Under the study conditions, the nominal 24 h EC50 and NOEC were 3.2 and 1.8 mg/L, respectively. The nominal 48 h EC50 and NOEC were 3.0 and 1.8 mg/L, respectively.

Executive summary:

A study was conducted to determine the acute toxicity of the read across substance, Amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl), to Daphnia magna according to OECD Guideline 202, in compliance with GLP. Daphnia (20 per group) were exposed to the test substance at concentrations from 0.10-10 mg/L for 48 h under static conditions. Immobility was determined at 24 and 48 h. No analytical dose verification was conducted. Under the study conditions, the nominal 24 h EC50 and NOEC were 3.2 and 1.8 mg/L, respectively. The nominal 48 h EC50 and NOEC were 3.0 and 1.8 mg/L, respectively (Wetton, 1996).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

3 mg/L

Additional information

A study was conducted to determine the acute toxicity of the read across substance, amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl), to Daphnia magna according to OECD Guideline 202, in compliance with GLP. Daphnia (20 per group) were exposed to the test substance at concentrations from 0.10-10 mg/L for 48 h under static conditions. Immobility was determined at 24 and 48 h. No analytical dose verification was conducted. Under the study conditions, the nominal 24 h EC50 and NOEC were 3.2 and 1.8 mg/L, respectively. The nominal 48 h EC50 and NOEC were 3.0 and 1.8 mg/L, respectively (Wetton, 1996).