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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:
November 1986 - January 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
For the aquatic toxicity studies, the test item content of the saturated test medium was determined at the start of the study and after 48 h of exposure using the method of chemical analysis as mentioned below. All samples were concentrated 200 times using solid phase extraction leading to a minimal detectable concentration of 5 µg/l.
Vehicle:
yes
Details on test solutions:
Considering the poor solubility of P5367 in water several attempts were made to achieve a homogeneous suspension of P5367 in tap water. Initially, stock solutions were made up with DMSO as a solvent. The concentrations of P5367 in DMSO were 5 mg/0.1 ml and 88 mg/0.1 ml (stock A and stock B respectively). From these stock solutions 0.1 ml was added to 1 litre water. Sonication of the test medium with 5 mg P5367 per litre water resulted in a suspension, but within 24 hours the formation of needle-like particles was observed. Addition of 0.1 m l of stock B resulted in the appearance of a clump of P5367 which could not be dispersed by ultra sonication. Hence, these stock solutions were not used in the tests with Daphnia magna. It was then decided to use an alternative method of test medium preparation.
Concentrations of P5367 were made up in water with the use of methanol (p.a., Merck) < 0.1 ml per liter water, which was evaporated before addition of the medium. The test medium was stirred for 24 hours before the Daphnia were added (see section results for further description of the method).
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna Straus (Crustacea, Cladocera)
- Age at study initiation: less than 3 days old
- Method of breeding: Batches of Daphnia magna Straus (Crustacea, Cladocera) were bred synchronously in standard tap water with a density of 25 Daphnia per liter. Each batch was started with newborn animals of less than 3 days old. About 250 of these Daphnia were placed into 10 liters of water in an all-glass culture vessel in a climate room. The temperature in the climate room, which stays illuminated for 16 hours per day, was kept on 19 -/+ 0.5°C. The organisms received food daily in the form of a suspension of Chlorella pyrenoidosa. After 7 days of cultivation half of the volume of the medium is renewed twice a week, Cultures older than 4 weeks are discarded.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
None
Hardness:
11.7° DH
Test temperature:
According to the study plan, the temperature should be maintained at 18 - 22°C +/- 1°C during the test. During the test, between 24 h and 48 h of exposure the temperature of the test medium decreased from 18.0°C to 17.5°C, however, such a marginal decrease of temperature had no significant influence on the results.
pH:
8.0 - 8.4
Dissolved oxygen:
7.2 - 9.2 mg/l O2
Salinity:
Freshwater used
Nominal and measured concentrations:
Main Test: 0.01 and 0.1 mg/l
Details on test conditions:
See explanations under "test solutions" and "results".
Reference substance (positive control):
yes
Remarks:
K2Cr207 was tested as a reference substance
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 0.02 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% CL could not be calculated
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 0.02 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% CL could not be calculated
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
0.02 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% CL could not be calculated
Details on results:
The maximum soluble concentration (MSC) was estimated to be 20 ug/l in Milli-Q water, using the HPLC-method for detection of MSC-values. In an experiment for the determination of the solubility of P5367 in water, methanol was used as a vehiculum to suspend 20 ug and 40 ug in 1 liter water respectively. These suspensions were kept in dark for 24 hours. Then samples were taken to measure the dissolved amount of P5367. It appeared that no dissolved P5367 could be detected. Next, Daphnia were exposed to 0.01 mg and 0.1 mg of P5367 per liter water respectively. This test was performed in duplicate together with a water-control and a solvent-control. No significant effects or mobility of Daphnia were observed after both 24 h and 48 h of exposure. The pH and oxygen concentrations were within the limits. On the basis of these results, it was decided not to carry out an additional experiment because even exposure of Daphnia to a saturated concentration of 0.1 mg P5367 did not reveal any effect on mobility.
Results with reference substance (positive control):
One week before the main study with P5367, K2Cr207 was tested as a reference substance, using Daphnia from the same culture. The 48 h EC50 was between 1.0 and 1.8 mg/l which is within the expected range (0.56-1.8 mg/l; n= 7). Since, in addition the oxygen concentrations were higher than 6.5 mg/l and the immobilisation in then control vessels did not exceed 10% it can be concluded that the test conditions were optimal and the results obtained are valid.
Validity criteria fulfilled:
yes
Conclusions:
The EC50 on Daphnia magna was > 0.1 mg/l (solubility limit of test item incl. solvent), corresponding to > 0.02 mg/l based on the water solubility.
Executive summary:

The study was performed 1987 as GLP-test following EU-testing method C.2 using Daphnia Magna as test species. The test was performed under static conditions with nominal test item concentrations of 0.01 and 0.1 mg/l in the main study. Due to the very low solubility of the test item, methanol was added as auxiliary agent to prepare the stock solutions. There were no efffects on daphnia observed throughout the main study at 0.1 mg/l nominal concentration, therefore, the EC50 was determined to be above the water solubility of 0.02 mg/l.

Description of key information

The study was performed in1987 as GLP-test following EU-testing method C.2 using Daphnia magna as test species. The test was performed under static conditions with nominal test item concentrations of 0.01 and 0.1 mg/l in the main study. Due to the very low solubility of the test item, methanol was added as auxiliary agent to prepare the stock solutions. There were no effects on Daphnia throughout the main study at 0.1 mg/L nominal concentration, therefore, the EC50 was determined to be above the water solubility of 0.02 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
0.02 mg/L

Additional information

Source: GLP-report