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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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2007-05-09 to 2007-11-08
Justification for type of information:
ANALOGUE APPROACH JUSTIFICATION
Please refer to the attached read across justification in section 13
Reason / purpose for cross-reference:
read-across source
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 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:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-05-09 to 2007-11-08
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:
2004
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
December 29th, 1992
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test medium (reconstituted water and test material) was freshly prepared. Therefore, the calibrated flask with test medium was treated in an ultrasonic device for 1 hour. Subsequently, the preparation was stirred with a magnetic stirrer for further 23 hours. The formulation was then passed through a single use syringe filter (pore size 0.2 pm). The filtrate was used for the study.
Test organisms (species):
Daphnia magna
Details on test organisms:
- Common name: Daphnia magna
- Strain/clone: Straus
- Justification for species other than prescribed by test guideline: OECD 202
- Age at study initiation: not older than 24 hours
- Source: Merck KGaA, Darmstadt, Institute of Toxicology
- Feeding during test: no
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
250 mg CaCO3/L
Test temperature:
21 - 22 °C
pH:
7.74 - 7.79
Dissolved oxygen:
90.8 - 91.3 [O2] %
Nominal and measured concentrations:
Nominal: 100 mg/L
Measured: below detection limit
Details on test conditions:
TEST SYSTEM
- Type: open static
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water (ELENDT 1990)

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

EFFECT PARAMETERS MEASURED:
Motility: the motility was determined visually and recorded after 24 and 48 hours. Those animals which were not able to swim within 15 seconds after gentle agitation of the test container, were considered to be immobile.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
Daphnia magna exposed to an aqueous preparation of the nominal concentration of 100 mg/L test item were not affected.
Results with reference substance (positive control):
Potassium dichromate:
24 h EC50 0.95 (0.87 - 1.04) mg/L
48 h EC50 0.74 (0.68 - 0.81) mg/L

After exposure of Daphnia magna to a nominal concentration of 100 mg/L for 48 hours, the following results were obtained:

Table 1

Nominal concentration

No. of Daphnia magna immobilized / exposed

[mg/L]

24 hours

48 hours

0

0/20

0/20

100

0/20

0/20

For the test item, the following nominal EC50 values for Daphnia magna were determined:

24 h EC50 > 100 mg/L

48 h EC50 > 100 mg/L

NOEC >= 100 mg/L (nominal)

LOEC > 100 m/L (nominal)

Validity criteria fulfilled:
yes
Conclusions:
Under the test conditions according to OECD TG 202 and under GLP, the 48 hour EC50 of the test item to Daphnia magna was determined to be >100 mg/L
Executive summary:

The objective of this aquatic toxicity study was to provide information on the influence of the test material on the mobility of Daphnia magna and to serve as a basis for classification and labeling purposes. EEC Directive 92/69 and OECD Guideline No. 202 recommend the method of application and the species Daphnia magna. For this purpose, juvenile Daphnia magna were exposed to an aqueous test material solution over 48 hours, under defined conditions. The study comprised of four test vessels per concentration containing five Daphnia magna each, i.e. 20 Daphnia magna per concentration (test medium group). Daphnia magna were exposed to a nominal test material concentration of 100 mg/L (limit test) in an open static system. An aqueous solution of nominal 100 mg/L of the test item revealed no aquatic toxicity in the test system. The 48 hour EC50 for Daphnia magna exceeded the maximum solubility of the test material in reconstituted water (< 0.06 mg/L) and, thus, could not be determined in this test. For the test material the following nominal EC50 values for Daphnia magna were determined to be 24 h EC50 > 100 mg/L and 48 h EC50 > 100 mg/L.

Description of key information

Under the test conditions according to OECD TG 202 and under GLP, the 48 h EC50 of the test item to Daphnia magna was determined to be >100 mg/L.

Key value for chemical safety assessment

Additional information

For this endpoint a one-to-one read across was performed to a chemical similar compound of the same chemical class with a comparable physicochemical profile and similar data in biological relevant assays. The study was performed according to GLP and the methods applied are fully compliant with OECD TG 202.

The objective of this aquatic toxicity study was to provide information on the influence of the test material on the mobility of Daphnia magna and to serve as a basis for classification and labeling purposes. EEC Directive 92/69 and OECD Guideline No. 202 recommend the method of application and the species Daphnia magna. For this purpose, juvenile Daphnia magna were exposed to an aqueous test material solution over 48 hours, under defined conditions. The study comprised of four test vessels per concentration containing five Daphnia magna each, i.e. 20 Daphnia magna per concentration (test medium group). Daphnia magna were exposed to a nominal test material concentration of 100 mg/L (limit test) in an open static system. An aqueous solution of nominal 100 mg/L of the test item revealed no aquatic toxicity in the test system. The 48 hour EC50 for Daphnia magna exceeded the maximum solubility of the test material in reconstituted water (< 0.06 mg/L) and, thus, could not be determined in this test. For the test material the following nominal EC50 values for Daphnia magna were determined to be 24 h EC50 > 100 mg/L and 48 h EC50 > 100 mg/L.