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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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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:
March to July 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
Qualifier:
according to guideline
Guideline:
ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Javanol
- Physical state: Pale yellow viscous liquid
- Analytical purity: 88.4% (GC, sum of two peaks)
- Lot/batch No.: 008825
Analytical monitoring:
yes
Details on sampling:
Frequency: At the start and the end of the test
Concentrations: Singular samples for analysis were taken from all test concentrations.
Volume: 50, 100 or 200 ml, depending on the expected concentration of Javanol. At the end of the test, the volumes of the test vessels were mixed with remaining volumes incubated under the same conditions. The samples were taken from these mixtures.
Storage: The samples not analysed on the day of sampling were stored in a deep-freeze until analysis.
Additionally, reserve samples of 50 ml were taken according to the same schedule. All reserve samples were stored in a deep-freeze for possible analysis until delivery of the final report with a maximum of three months.
Vehicle:
yes
Remarks:
A stock solution of JAVANOL was prepared at 100 mg/mL in acetone. 0.1 mL of this stock was aded per litre of medium and the solution stirred overnight to homogenise.
Details on test solutions:
Preparation of test solutions:
The standard test procedures required generation of test solutions which should contain completely dissolved test substance concentrations or stable and homogeneous mixtures or dispersions. The testing of concentrations that disturb the test system should be prevented (e.g. film of the test substance on the water surface).
JAVANOL is a clear viscous liquid which is insoluble in water. The water solubility of JAVANOL according to the sponsor is 3.8 mg/1 at 20°C (Test report 97-E81/P). The procedure for preparation was based on research by the Analytical department during method development and validation. This procedure included filtration of the stock solution through a 0.2 um filter (NOTOX Project 222659).
A stock solution was prepared at a JAVANOL concentration of 100 mg/mL in acetone. Per litre of test medium 0.1 ml of this stock was added and the stock was stirred overnight. Prior to testing, this stock solution was filtered through a 0.2 um filter to obtain the fraction actually dissolved. The filtrate was a clear and colourless solution. This filtrate was further diluted to prepare the final test concentrations. The total volumes of test solutions included those necessary for sampling for analysis at both the start and the end of the test period. A total of 160 ml were used in the test vessels and the remaining volumes were incubated under the same conditions during the test period.
Test organisms (species):
Daphnia magna
Details on test organisms:
For the test selection young daphnia with an age < 24 hours. For full test young daphnia from two bulk and individual cultures were combined.
Reason for selection: this sytem has been selected as an internationally accepted species.
Validity of batch: Frequent inspection of the cultures with respect to number of young, appearance of young and parental daphnia and global feeding behaviour.
Maximum age of the cultures: 4 weeks
Renewal of the cultures: after 7 days of cultivation half of the medium twice a week.
Feeding: Daily, a suspension of fresh water algae.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Test temperature:
Between 20.1 and 20.4°C
pH:
Between 7.8 and 8.1
Dissolved oxygen:
Between 8.8 and 9.1 mg/L
Nominal and measured concentrations:
In the definitive test :
Time 0 -
Solvent Control Not Detected
1.0% Dilution of Stock 0.0474 mg/L
2.2% Dilution of Stock 0.108 mg/L
4.6% Dilution of Stock 0.241 mg/L
10% Dilution of Stock 0.437 mg/L
22% Dilution of Stock 1.02 mg/L
46% Dilution of Stock 2.04 mg/L

At 48 hours :
Solvent Control Not Detected
1.0% Dilution of Stock 0.0156 mg/L
2.2% Dilution of Stock 0.0317 mg/L
4.6% Dilution of Stock 0.0915 mg/L
10% Dilution of Stock 0.227 mg/L
22% Dilution of Stock 0.624 mg/L
46% Dilution of Stock 1.36 mg/L

Concentrations of JAVANOL determined in 48 hour old exposure solutions were between 29.4 and 66.7% of the Time 0 concentrations.
Details on test conditions:
Test type: Static
Test duration: 48 hours
Test vessels: 100 ml, all-glass
Medium: ISO, prepared in milli-R0 water
Number of daphnia: 20 per concentration
Loading: 10 per vessel containing 80 ml medium
Light: 16 hours/8 hour light/dark cycle
No feeding
No aeration of the test solutions
Introduction of Daphnia: within 1 hour after preparation of the test solutions
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
0.15 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
0.69 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% Ci : 0.58 - 0.87 mg/L
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
0.38 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% CI : 0.30 - 0.52 mg/L
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
1.67 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
The EC50 values were based on the actual average exposure concentrations expressed as mg/l. Since there was 50% response at the lowest dosage in test 1, only the results of the final study were used to determine the EC50 values. The values for average concentrations were used to calculate the EC50 values and the respective parameters.
Results with reference substance (positive control):
The 24h-EC50 was 1.3 mg/l with 0% immobility at 1.0 mg/l and 100% immobility at 1.8 mg/l.
The 48h-EC50 was 0.8 mg/l with 95% fiducial limits of 0.7 and 1.1 mg/l.
Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of the present 48-hour study, Javanol did not induce significant acute immobilization of Daphnia magna at 0.15 mg/l (NOEC).
The 24h-EC50 was 0.69 mg/l based on average exposure concentrations (95% confidence interval between 0.58 and 0.87 mg/l).
The 48h-EC50 was 0.38 mg/l based on average exposure concentrations (95% confidence interval between 0.30 and 0.52 mg/l). The 48-hour EC100 corresponded with an average concentration of 1.67 mg/l.
Executive summary:

The study procedures described in this report were based on the ISO International Standard 6341, the EEC directive 92/69, Part C.2. and the OECD guideline no 202, adopted April 4, 1984.

Javanol is a clear viscous liquid which is hardly soluble in water. The water solubility of Javanol is 3.8 mg/l (at 20°C) according to data of the sponsor. The procedure for preparation was based on research by the Analytical department during method development and validation. This procedure included filtration of the stock solution through a 0.2 micrometer filter.

After a range-finding test, two full tests were performed. The test solutions contained various amounts of a 0.2 micrometer filtrate prepared at nominal 10 mg/l with acetone as presolvent (0.1 ml/l). Analytical support showed that Daphnia magna were exposed to a range of initial Javanol concentrations of 0.5 to 5 mg/l in the first test and 0.05 to 2 mg/L in the second definitive test. The test period was 48 hours and both studies were performed in duplicate with 10 daphnia per vessel and included a blank and solvent-control (0.1 ml/l acetone).

Analysis of the samples taken at the end of the full tests showed that the actual test concentrations were not stable during the exposure period and could not be maintained at 80% pf the initial concentration. Hence, EC50 values were based on the average exposure concentrations.

Javanol did not induce significant acute immobilization of Daphnia magna at 0.15 mg/l (NOEC).

The 24h-EC50 was 0.69 mg/l based on average exposure concentrations (95% confidence interval between 0.58 and 0.87 mg/l).

The 48h-EC50 was 0.38 mg/l based on average exposure concentrations (95% confidence interval between 0.30 and 0.52 mg/l). The 48 -hour EC100 corresponded with an average concentration of 1.67 mg/l.

Description of key information

Under the conditions of the present 48-hour study, Javanol did not induce significant acute immobilization of Daphnia magna at 0.15 mg/L (NOEC).


The 24h-EC50 was 0.69 mg/L based on average exposure concentrations (95% confidence interval between 0.58 and 0.87 mg/L).


The 48h-EC50 was 0.38 mg/L based on average exposure concentrations (95% confidence interval between 0.30 and 0.52 mg/L).


The 48-hour EC100 corresponded with an average concentration of 1.67 mg/L.

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Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
0.38 mg/L

Additional information

The 48h-EC50 was 0.38 mg/L based on average exposure concentrations (95% confidence interval between 0.30 and 0.52 mg/L).

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