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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 Aug 2020 - 15 Apr 2021
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:
adopted 2004
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: all concentrations
- Sampling method: sampling at 0h and 24 (fresh solutions) and after 24 and 48 h (aged solutions)
- Sample storage conditions before analysis: The samples were mixed with 10 mL acetonitrile and stored deep-frozen (≤ - 18 °C) until analysis.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution with a nominal concentration of 25 mg/L was prepared by adding the necessary amount of test item to a volumetric flask. Test medium was added and the solution was homogenised by shaking. The solution was observed to be clear and transparent; foam was observed. Test item concentrations were prepared by dilution with test medium. Test solutions were observed to be clear and transparent.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain/clone: Clone V
- Age at study initiation (mean and range, SD): < 24 h
- Method of breeding: Daphnia magna was bred as single culture (1 daphnid per 100 mL) in Elendt M4 medium. pH-value: 6.0 – 9.0, dissolved oxygen: > 60 % saturation, total hardness 140 - 250 mg/L (as CaCO3), fed with single cell green algae (Desmodesmus subspicatus, formerly Scenedesmus subspicatus) at least three times a week.
- Source: bred at testing faciltiy, originally obtained from the Federal Environment Agency in Berlin/Germany.
- Feeding during test: none

ACCLIMATION
- Acclimation period: none
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
232 mg/L CaCO3
Test temperature:
19.8 - 20.4 °C
pH:
7.78 – 8.08
Dissolved oxygen:
8.74 ± 0.17 mg/L
Nominal and measured concentrations:
Nominal concentrations of 5.00, 2.50, 1.25, 0.625, 0.313 mg/L
Time weighted mean concentrations: 3.62, 1.54, 0.753, 0.366, 0.183 mg/L (based on 3 representative constituents)
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beakers (nominal: 100 mL)
- Type (delete if not applicable): covered by glass plate
- Volume of solution: ≥ 50 mL
- Aeration: none
- Renewal rate of test solution (frequency): after 24 h
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Loading rate: ≥ 10 mL / animal

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4 medium
- Culture medium different from test medium: no
- Intervals of water quality measurement: Temperature, pH-value and oxygen concentration were measured after 0, 24 hours (aged and fresh) and 48 hours

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light and 8 hours darkness
- Light intensity: 903-1443 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mobility and behavioural changes at 24 and 48 h

RANGE-FINDING STUDY
- Test concentrations: 0.050, 0.50, 5.00, 50.0 mg/L
- Results used to determine the conditions for the definitive study: EC50 (48 h) >0.50 mg/L < 5 mg/L
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
1.95 mg/L
95% CI:
>= 1.67 - <= 2.29
Nominal / measured:
meas. (TWA)
Conc. based on:
other: based on three representative constituents
Remarks:
C10EO2, C10EO3, C10EO6
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
0.753 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
other: based on three representative constituents
Remarks:
C10EO2, C10EO3, C10EO6
Basis for effect:
mobility
Details on results:
- Mortality of control: no
- Other adverse effects control: After 48 hours two mobile daphnids in the control group and one mobile daphnid at the test item concentration 0.313 mg/L were observed as being stuck at the surface.
The appearance of test solutions was clear and transparent in all nominal test item concentrations at all observations.
Results with reference substance (positive control):
EC50 (24 h) of the reference item potassium dichromate: 0.6 - 2.1 mg/L (test started on 18 Aug 2020).
Reported statistics and error estimates:
The NOEC was determined based on the highest test concentration at which no significant immobilisation was determined after 24 and 48 hours test duration.
The EC50 after 24 was not determined statistically. The 48 hours EC50 was determined by trimmed Spearman-Karber procedure.

Table 1: Validity criteria for OECD 202 (2004)

Criterion from the guideline

Outcome

Validity criterion fulfilled

In the control, including the control containing the solubilising agent, not more than 10% of the daphnids should have been immobilized.

0%

yes

The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels.

≥ 8.2 mg/L

yes

Table 2:  Results of the test, 48 h values

 

TWA [mg/L]

 

Control

0.183

0.366

0.753

2.54

3.62

 

Immobilised daphnids after 48 h

Replicate 1

0

0

0

0

0

5

Replicate 2

0

0

1

0

0

5

Replicate 3

0

0

0

0

2

5

Replicate 4

0

1

0

0

1

5

Σ

0

1

1

0

3

20

%

0

5

5

0

15

100

 

Validity criteria fulfilled:
yes
Remarks:
Please see table 1 at "any other information on results incl. tables"
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
26 Oct - 28 Oct 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
no guideline followed
Principles of method if other than guideline:
The acute toxicity to Daphnia magna was determined under static conditions.
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): acetone
- Concentration of vehicle in test medium (final test solution): 0.1 ml/L
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Source: Laboratory culture obtained from ICI Brixham Laboratory; original source: I.R.Ch.A., France
- Age at study initiation (mean and range, SD): < 24 h

CULTURE
- Culture conditions: glass vessels (0.5 - 4 L) containing reconstituted fresh water. New cultures are started with animals < 24 h old, at a density of about 20 per litre. Cultures are held in a temperature controlled room at 18 – 22 °C and artificial light in a 16 h light/8 h dark cycle. The water in the vessels is renewed weekly and the cultures are discarded when they are 5 weeks old or if there appear ephippia.
- Type and amount of food: Chlorella vulgaris, approx. 1E06 cells/mL in the Daphnia vessels
- Feeding frequency: daily
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
160 mg/L as CaCO3
Test temperature:
18 - 22 °C
pH:
8.2 - 8.3
Dissolved oxygen:
8.5 - 9.2 mg/L
Nominal and measured concentrations:
Nominal: 0.5, 1.1, 2.3, 4.8, 10, 22, 47, 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Crystallising dishes
- Material, fill volume: glass, fill vol. 150 mL
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 3
- No. of vessels per vehicle control (replicates): 3

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted fresh water containing 192 mg/L NaHCO3, 120 mg/L CaSO4*2H2O, 120 mg/L MgSO4, 8 mg/L KCl
- Aeration: Test water was aerated 24 h before use and was assumed to be saturated with dissolved oxygen
- Ca/Mg ratio: 1:1
- Culture medium different from test medium: no
- Intervals of water quality measurement: Monitoring of temperature in one test vessel every 4 h, pH and dissolved oxygen was measured in one control and the highest test concentration at test start and test end.

OTHER TEST CONDITIONS
- Photoperiod: 16 h light/8h dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Immobilisation was recorded after 24 and 48 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: approx. 2.0
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
2.5 mg/L
95% CI:
>= 2.1 - <= 2.9
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility

24 h EC50 value: 4.8 mg/L, 95% CL = 4.0 - 5.8 mg/L

Table: Immobilisation of D. magna

Concentration of test substance (mg/L)

Number of D. magna

Number immobilised

24 h

48 h

Control

10

0

0

Control

10

0

0

Control

10

0

0

0.5

10

0

0

0.5

10

0

0

0.5

10

0

0

1.1

10

0

2

1.1

10

0

0

1.1

10

0

0

2.3

10

1

3

2.3

10

2

4

2.3

10

1

5

4.8

10

4

8

4.8

10

6

10

4.8

10

6

10

10

10

9

10

10

10

8

10

10

10

8

10

22

10

10

10

22

10

10

10

22

10

10

10

47

10

10

10

47

10

10

10

47

10

10

10

100

10

10

10

100

10

10

10

100

10

10

10

Validity criteria fulfilled:
not specified
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
26 Oct - 30 Oct 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Guidelines issued by the Ministry of Agriculture, Fisheries and Food, Burnham-on-Crouch, UK
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Direct dispersion in water
Test organisms (species):
Crangon crangon
Details on test organisms:
TEST ORGANISM
- Common name: Brown shrimp
- Source: P. Garnett, King's Lynn, Norfolk, UK
- Weight at study initiation (mean and range, SD): mean 1.32 g, SD 0.41
- Length at study initiation (length definition, mean, range and SD): mean 4.5 cm, SD 0.6

ACCLIMATION
- Acclimation period: 19 Oct - 26 Oct 1989
- Acclimation conditions (same as test or not): 14 °C, dissolved oxygen ≥ 8.1 mg/L
- Health during acclimation (any mortality observed): < 5% in 4 days prior to test
Test type:
semi-static
Water media type:
saltwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
14 °C
Nominal and measured concentrations:
Nominal: 1.8, 3.2, 5.6, 10 and 18 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: aquarium
- Material, size, headspace, fill volume: glass, fill volume 20 L
- Aeration: Via narrow bore glas tubes
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 20
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 1.3 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Synthetic sea water at 32 o/oo S
- Aeration: ≥ 12 h prior to use

OTHER TEST CONDITIONS
- Photoperiod: 16 h light/8 h dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality and abnormal behaviour was recorded after 3, 6, 24, 48, 72 and 96 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
9.9 mg/L
95% CI:
>= 8.9 - <= 11
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: Lethargy was observed at 10 mg/L
- Mortality of control: no mortality and no abnormality

Table 1: Effect concentrations for time points < 96 h

Duration

Endpoint

Effect conc.

Nom./Meas.

Conc. based on

Basis for effect

Remarks

3 h

LC50

15mg/L

nominal

test mat.

mortality

95% CL = 14 - 16 mg/L

6 h

LC50

14mg/L

nominal

test mat.

mortality

95% CL = 13 - 15 mg/L

24 h

LC50

12 mg/L

nominal

test mat.

mortality

95% CL = 11 - 13 mg/L

48 h

LC50

11 mg/L

nominal

test mat.

mortality

95% CL = 9.9 - 12 mg/L

72 h

LC50

10 mg/L

nominal

test mat.

mortality

95% CL = 9.3 - 11 mg/L

Table 2: Lethal time for the two highest concentrations

Concentration

LT50 (h)

95% CL (h)

10

88

44 - 180

18

0.5

0.2 – 1.2

Table 3: Cumulative mortality data for brown shrimp exposed for 96 h

Concentration mg/L

Cumulative mortality (initial population: 20)

3 h

6 h

24 h

48 h

72 h

96 h

Control

0

0

0

0

0

0

1.8

0

0

0

0

0

0

3.2

0

0

0

0

1

1

5.6

0

0

0

0

0

2

10.0

2

2

4

5

6

7

18.0

17

20

20

20

20

20

Validity criteria fulfilled:
not specified

Description of key information

EC50 (48 h): 1.95 mg/L (TWA)

Key value for chemical safety assessment

Additional information

One key study investigating the acute toxicity of Alcohols, C9-11, branched and linear, ethoxylated to aquatic invertebrates is available. The GLP guideline study was conducted under semi-static conditions according to OECD 202. The test organism, Daphnia magna, was exposed to nominal test item concentrations of 0.313, 0.625, 1.25, 2.50 and 5.00 mg/L. Test solutions were renewed every 24 hours.

The test concentrations were analytically monitored by HPLC-MS/MS. The time weighted mean measured concentrations, based on three representative constituents of the UVCB substance, were 0.183, 0.366, 0.753, 1.54 and 3.62 mg/L The determined EC50 (48 h) was 1.95 mg/L (TWA).

 

Two supporting studies are available. In a static test on conducted with Daphnia magna an EC50 (48 h) of 2.5 mg/L (nominal) was determined. A semi-static test on the marine species Crangon crangon determined a LC50 (96 h) of 9.9 mg/L (nominal).