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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:
experimental study
Adequacy of study:
key study
Study period:
1992-03-05 to 1992-03-07
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)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OTS 797.1300 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 101.6 mg/L (nominal concentration)

- Sampling method: high performance liquid chromatography (HPLC)

- Sample storage conditions before analysis: Test concentrations were verified by chemical analysis. Water samples (~ 50 mL) were taken from the control and test level (replicates pooled) at 0 hours and 48 hours, membrane filtered (0.45 µm) and stored at ca. -20 °C prior to being sent for analysis.
Vehicle:
no
Details on test solutions:
The test substance was dissolved in test water to give an stock solution of 400 mg/L (equivalent to 101.6 mg active ingredient/L).
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain: Straus
- Source: Institute National de Recherche Chimique Appliquée (IRChA), France
- Age at study initiation: less than 24 hours
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
171 mg CaCO3/L
Test temperature:
21 °C
pH:
7.9 - 8.0
Dissolved oxygen:
7.9 - 8.3 mg O2/L
Nominal and measured concentrations:
nominal: 400 mg/L (= 101.6 mg active ingredient/L)
measured: 94 mg active ingredient/L
Details on test conditions:
TEST SYSTEM
- Test vessel: glass jar
- Type: open
- fill volume: 200 mL
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source of dilution water: Laboratory tap water filtered, dechlorinated and softened by passage through an Elga® water purification system
- Culture medium different from test medium: no


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light/8 hours dark


EFFECT PARAMETERS MEASURED: EC50; Daphnia were considered to be immobilised if they were unable to swim for approximately 15 seconds after gentle agitation.

Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
>= 400 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 400 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: No
- Mortality of control: No
- Other adverse effects control: none
- Abnormal responses: No

Table 1: EC50 values

Time (h)

EC50 (mg a.i./L)

95% confidence limits (mg a.i./L)

24

> 100

-

48

> 100

-

NOEC at 24 h: ≥ 100 mg a.i./L

NOEC at 48 h: ≥ 100 mg a.i./L

a.i. – active ingredient

 

Table 2: Cumulative immobilisation data for Daphnia magna exposed for 48 hours to test item

Nominal concentration (mg a.i./L)

Measured concentration

(mg a.i./L)

Cumulative immobilised Daphnia magna

(initial population: 10 per replicate)

24 hours

48 hours

Total %

Total %

Control

R1

Control

R1

0

0

0

0

0

0

R2

R2

0

0

0

0

0

0

100

R1

94

R1

0

0

0

0

0

0

R2

R2

0

0

0

0

0

0

R3

R3

0

0

0

0

0

0

R4

R4

0

0

0

0

0

0

R1 Replicate 1

R2 Replicate 2

R3 Replicate 3

R4 Replicate 4

 

Table 3: Measured concentrations (Mean values and percentages of nominal)

Nominal concentration

(mg a.i./L)

Number of samples analysed

Measured concentration

(mg a.i./L)

% Nominal

Control

2

-

-

101.6

2

94.4

93

Validity criteria fulfilled:
yes
Conclusions:
Under the test conditions of the present acute toxicity study in Daphnia magna with the 25.4 % aqueous test solution according to OECD 202, the 48 h EC50 (immobilisation) value was > 100 mg/L (based on active ingredient).
Executive summary:

The potential of the test item to cause acute toxicity in daphnia magna was investigated in a study conducted in accordance with OECD 202 and EU method C2 under GLP conditions. For this purpose, young daphnids were exposed under static conditions for 48 hours to one concentration of the test item dissolved in water. The incidence of immobilisation was recorded for the test and control group at 24 hours and at 48 hours and the following values determined:


EC50 (24 h) > 100 mg/L


EC50 (48 h) > 100 mg/L


NOEC (24 h): ≥ 100 mg/L


NOEC (48 h): ≥ 100 mg/L


All validity criteria were met. All results were expressed in terms of nominal concentrations of active ingredient since the measured levels remained near nominal throughout the study (96 % of nominal at 0 hours and 89 % of nominal at 48 hours: average, 93 %).

Description of key information

Under the test conditions of the present acute toxicity study in Daphnia magna with the 24.5 %  aqueous test solution according to OECD 202, the 48 h EC50 (immobilisation) value was > 100 mg a.i./L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
EC50
Effect concentration:
100 mg/L

Additional information

The potential of the test item to cause acute toxicity in daphnia magna was investigated in a study conducted in accordance with OECD 202 and EU method C2 under GLP conditions. For this purpose, young daphnids were exposed under static conditions for 48 hours to one concentration of the test item dissolved in water. The incidence of immobilisation was recorded for the test and control group at 24 hours and at 48 hours and the following values determined:

EC50 (24 h) > 100 mg/L

EC50 (48 h) > 100 mg/L

NOEC (24 h): ≥ 100 mg/L

NOEC (48 h): ≥ 100 mg/L

All validity criteria were met. All results were expressed in terms of nominal concentrations since the measured levels remained near nominal throughout the study (96 % of nominal at 0 hours and 89 % of nominal at 48 hours: average, 93 %)