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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:
weight of evidence
Study period:
1998-03-11 to 1998-03-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted in accordance with international guidelines and in accordance with GLP. All relevant validity criteria were met.
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
For all concentrations (1 test vessel per concentration), 0.75 mL of test solution was collected four times during the exposure period before and after water renewal, and analysed for test substance concntration. An equal amount of acetone was added to each aliquot before analysis on GC.
Vehicle:
yes
Details on test solutions:
100 mg of test substance was dissolved in 250 mg of HCO-40 was added and the solution was mixed. The solution was diluted in 100 mL od of pure water to make a stock of 1000 mg/L. A stock of solvent controls was also made at 2500 mg/L HCO-40 without test substance. The appropriate amount of stock was added to a 500 mL volumetric flask with 500 mL medium to acheive each test concntration. 10 mL of the corresponding solution was used per replicate test vessel (n = 4) at each test concentration or control. The test concentrations were 0, 0 (solvent only) and 40 mg/L test substance.
Test organisms (species):
Daphnia magna
Details on test organisms:
- Source:National Institute for Environmental Studies, Japan (18 July 1995) and continuously reared at Yokohama Laboratory since obatiainment in Elendt M4 medium.
- Stocks were created with healthy females, the juvenilles from these females were sperated and further cultured until maturation. The neonates (not first brood) from the final subculture were used in the test.
- Test Daphnia were < 24 hours old
- Food: Chlorella vulgaris, 0.15 mg C (organic carbon)/ day
- Exposure method: semi-static (3 times per week, replace the total amount of the test solution)
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
immobility
Hardness:
63 mg/L CaCO3
Test temperature:
20.0 - 20.3 °C measured at each test vessel at the beginning and the end of the test
pH:
7.6 - 7.8 measured at each test vessel at the beginning and the end of the test
Dissolved oxygen:
7.5 - 8.4 mg O2/L measured at each test vessel at the beginning and the end of the test
Nominal and measured concentrations:
Concentration of the test item: 40.0 mg/L (38.8 mg/L = 97 % nominal), control and vehicle control
Details on test conditions:
Less than 24 hour old Daphnia magna were exposed under static non-renewal conditions for 48 hours in 100 mL beakers filled with 100 mL test media. The photoperiod was 16:8 h light:dark. Daphnia were not fed during the experiment. Daphnia were exposed to, control, solvent control of 40 mg/L of the test substance.
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 40 mg/L
Nominal / measured:
nominal
Remarks on result:
other: Nominal values were adopted for calculation of each effect concentration, because all measurement concentrations of test substance were within ±20 % of nominal values.
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
> 40 mg/L
Nominal / measured:
nominal
Remarks on result:
other: Nominal values were adopted for calculation of each effect concentration, because all measurement concentrations of test substance were within ±20 % of nominal values.
Details on results:
There was no mortality in the control, solvent control or test substance exposures.
Results with reference substance (positive control):
EC50 0.23 mg/L

Test substance concentrations in test solution:

- Nominal values were adopted for calculation of each effect concentration, because all measurement concentrations of test substance were within ± 20 % of nominal values.

Results after 24-hour exposure:

- Median immobilization concentration (EC50): > 40.0 mg/L

- No observed effect concentration (NOEC): > 40.0 mg/L

Results after 48-hour exposure:

- No observed effect concentration (NOEC): > 40.0 mg/L

- EC50: > 40.0 mg/L

Validity criteria fulfilled:
yes
Conclusions:
The 24 and 48 hour EC50 and NOEC were > 40 mg/L.
Executive summary:

The acute toxicity to aquatic invertebrates (Daphnia magna) was determinated according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) under static conditions. After 48 hours exposure an EC50 and NOEC were > 40 mg/L.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2007-12-21 to 2008-01-25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The study was conducted in accordance with international guidelines and in accordance with GLP. All relevant validity criteria were met. Although there is no analytical verification of exposure to the test item in this study, the test is acceptable for the derivation of an EL50 as per OECD GD 23 (Guidance Document on the Aquatic Toxicity Testing of Difficult Substances and Mixtures), and is therefore considered in the weight-of-evidence for this endpoint.
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
Concentration were determined at the start and the end of the test.
Vehicle:
no
Details on test solutions:
A limit test was conducted without use of a vehhicle. 100 mg/L of test substance was strirred for 48 hours at 20 ºC. After 48 hours the mixture was left to stand for 1 hour and then the liquid from the middle layer was collected and used for the test.
Test organisms (species):
Daphnia magna
Details on test organisms:
Daphnia magna (Clone A) were obtained from Sheffield S10 2UQ, United Kingdom. The Daphnia were continuously bred since obtainment at Kurume office for CERI. Daphnia were kept at 20 ± 1 ℃with a Photoperiod of 16:8 hours light-dark.. Daphnia were fed with Chlorella vulgaris (0.1 - 0.2 mg C/dpahnid/day).

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Post exposure observation period:
Mortality/ immobility
Hardness:
37 mg CaCO3/L
Test temperature:
19.9 - 20.1 °C measured at each test vessel at the beginning and the end of the test
pH:
7.8 - 7.9 measured at each test vessel at the beginning and the end of the test
Dissolved oxygen:
8.5 - 8.7 mg O2/L measured at each test vessel at the beginning and the end of the test
Nominal and measured concentrations:
Both exposure concentrations were not quantifiable.
The water solubility of the test substance is < 0.021 mg/L (i.e.
Details on test conditions:
Daphnia were exposed to the test substance in a static non-renewal test, in 100 mL of test media with 5 daphnids per replicate (n = 4). Daphnds were less than 24 hours old at the start of the test and were not fed during the test.

TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: highest test concentration was at the test substance limit for water solubility
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 0.021 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Value presents the Limit of Quantification (LOQ) of the analytical method.
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Value based on the (columnar liquid extraction) setting doping concentration.
Details on results:
No effects, sublethal or otherwise were observed during the test.
Results with reference substance (positive control):
EC50 = 0.28 mg/L

48h EC50 (half of immobilizatiotn concentration = > solubility of the test substance

48h EL50 (half immobilization addition concentration) = > 100 mg/L

Validity criteria fulfilled:
yes
Remarks:
(- Immobilization rate of the control group should not exceed 10 % during the exposure period. - Dissolved oxygen concentration must be at 3 mg/L or higher at the end of the exposure time.)
Conclusions:
The EC50 was greater than the limit of solubility and the EL50 was >100 mg/L.
Executive summary:

In order to test acute toxicity to invertebrates of the substance, Daphnia magna were exposured to 1 nominal loading rate of the test substance (100 mg/L) and blank conctrol solution for a period of 48 hours under static conditions. Mobility and visible abnormalities were recorded at 24 and 48 hours. No immobility of the organisms was observed during the test. The EC50 was > solubility mg/L and the EL50 was >100 mg/L.

Description of key information

EL50 (Daphnia magna); > 100 mg/L (nominal); EC50 > 0.021 mg/L (LOD),  OECD 202, Anon (2008)

EC50 (Daphnia magna); > 40 mg/L (meas.); OECD 202, Anon (2008)

Key value for chemical safety assessment

Additional information

A weight of evidence was used to define the endpoint for short-term toxicity to aquatic invertebrates, using two reliable studies: Anon (2008) and Anon (1998).

Anon (2008) utilised the approach described in OECD 23 (Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures) for poorly water soluble substances, testing a water accommodated fraction at the regulatory limit concentration of 100 mg/L WAF (measured concentration <0.021 mg/L (LOD)). No immobilisation was observed at this limit concentration, concluding that the EC50 was greater than the limit of water solubility.

Anon (1998) used a dispersant to enhance the solubility in the test medium (as described in OECD 202) achieving a maximum measured concentration of 40 mg/L which was used as the concentration in a limit test. No immobility of daphnids was observed at the limit concentration and the EC50 was determined to be >40 mg/L (and thus greater than the limit of water solubility).

Due to the substance not causing immobility at, or above, the limit of water solubility the substance was concluded as not acutely toxic to aquatic invertebrates and no hazard has been identified for this endpoint in accordance with REACH Annex I (section 3).