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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Residue analysis was not performed on actual test concentrations. This does not invalidate the overall significance of the study.
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes
Test material information:
Composition 1
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 104663
- Purity: 98.9%

OTHER SPECIFICS:
White powder
Test substance is not volatile
Analytical monitoring:
yes
Details on sampling:
- Concentrations:
- Sampling method: at 0 and 48 hours
- Sample storage conditions before analysis:
Vehicle:
no
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna STRAUS
- Strain/clone: no data
- Source: Animals bred at the testing facility, originally derived from the German Federal Environmental Ageny (Umweltbundesamt)
- Age of parental stock: Neonates 2 - 24 hrs old
- Feeding during test: no

ACCLIMATION
- Acclimation conditions: In Elendt M4 medium; 20 +/- 1 °C, 12:12 hrs light:dark cycle
- Type and amount of food: Schenedesmus (current name: Desmodesmus) subspicatus green algae, no data about amount and frequency
Test type:
static
Water media type:
freshwater
Total exposure duration:
48 h
Test temperature:
20 +/- 1 °C
pH:
7.2 – 7.6 (both tests)
Dissolved oxygen:
8.2 – 8.4 mg/L (first test), 8.4 – 10 mg/L (second test)
Nominal and measured concentrations:
Initial concentrations : First test: 3, 4.2, 5.9, 8.2, 11.5 µg/L, plus control, Second test: 11.5, 16.1, 22.5 µg/L, plus control
Actual concentrations: Nominal test concentrations were around or below the quantification limit (10 µg/L); test substance stability was therefore tested seperately at a concentration of 500 µg/L (41% after 0 h, 41% after 24 h, 37% after 48 h). It reveals that these results are also not reliable, due to unknown reasons.
Details on test conditions:
TEST SYSTEM
- Test vessel: 20 mL
- Type: open
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- Biomass loading rate: 4 mL/animal

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted medium as given in guideline OECD 202
- Culture medium different from test medium: Yes, daphnids were reared in Elendt M4 medium (as given in guideline OECD 202)

EFFECT PARAMETERS MEASURED: Immobility, sampled at 24 and 48 hours
Reference substance (positive control):
not required
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 0.008 - < 0.011 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
0.006 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
0.022 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Mortality of control: No immobilisation, 100 % survival

  Effect data (Immobilisation):

Test substance Concentration

(nominal)

[mg/l]

ImmobileDaphnia

 

 

Number

Percentage

O2

[mg/l]

48 h

pH

 

48 h

24 h

48 h

24 h

48 h

Control (1)

0

0

0

0

8.3

7.5

0.0115 (1)

3

11

15

55

8.2

7.4

0.0082 (1)

3

4

15

20

8.3

7.4

0.0059 (1)

0

0

0

0

8.3

7.4

0.0042 (1)

0

0

0

0

8.3

7.4

0.003 (1)

0

0

0

0

8.3

7.4

Control (2)

0

0

0

0

8.7

7.2

0.0225 (2)

3

20

15

100

8.4

7.2

0.0161 (2)

1

17

5

85

8.4

7.2

0.0115 (2)

2

12

10

60

8.6

7.2

(1)    = 1st test, (2) = 2nd test

 

The 24h-EC values were not determinable

Validity criteria fulfilled:
yes
Conclusions:
The test results indicate that octenidine dihydrochloride is acutely very toxic towards Daphnia magna.
Executive summary:

The test was performed according to the OECD guideline 202. The water flea Daphnia magna STRAUS (Crustacea: Cladocera) was used as the test organism on acute toxicity of Octenidine dihydrochloride towards invertebrates.

In the first test animals were exposed to five concentrations of Octenidine dihydrochloride, ranging from 3.2 to 11.5 µg/L and a control group. All concentrations were tested using 4 replicate treatments with 5 animals each. The test was performed at 20 °C and in complete darkness in a reconstitued medium according to OECD guideline 202. Immobili­sation was assessed at 24 and 48 hours, physico-chemical water parameters were measured at 0 and 48 hours.

Because less than 100 % immobility was yielded in the highest concentration, a second test was run under the same conditions, employing concentrations of 11.5, 16.1 and 22.5 µg/L and a control group.

Actual concentrations of Octenidine dihydrochloride were assayed by HPLC after 0, 24 and 48 hours in separate vessels but results were unreliable.

Octenidine dihydrochloride was found to be acutely very toxic towards Daphnia magna. Residue analysis of test concentrations was impossible because the HPLC method was not sufficiently sensitive. Also, results from a seperate test at a higher substance concentration in a blank vessel were not reliable.

Due to unreliable results of the octenidine dihydrochloride analyses, measured values are estimated by applying the mean percent recovery rates obtained from the test on D. magna reproduction. A geometric mean of initial (94.3% at 0 h) and final (51.3% at 48 h) percent recovery values, as required by OECD 202, was applied as follows:

(94.3 · 51.3)½= 69.55

Thus, nominal values are divided by 69.55% to give the measured average values.

Except stability of the test substance concentration all validity criteria according to the test guideline OECD 202 are met in both tests performed during this study.

EC0

0.0042 mg/L (measured average)

EC50

between 0.0058 and 0.008 mg/L (measured average)

We propose the arithmetic mean to be used as EC50

EC50= 0.0068 mg/L (measured average)

 EC100

0.0156 mg/L(measured average)

Description of key information

Acute toxicity towards invertebrates was tested with the water flea Daphnia magna, and the EC50 was established at approximately 0.007 mg/L.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
0.007 mg/L

Additional information

Analytical monitoring of the test substance was performed during this study. However, for unknown reasons results from vessels with organisms delivered inconsistent and unreliable results. Therefore, measured concentrations refer to the results from blank vessels without organisms, which were set up in parallel to the biotests.