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Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Administrative data

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).

Description of key information

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).