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Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2012

Materials and methods

Test guidelineopen allclose all
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)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
8-(butan-2-yl)-5,6,7,8-tetrahydroquinoline
EC Number:
938-871-2
Cas Number:
6613-31-6
Molecular formula:
C13H19N
IUPAC Name:
8-(butan-2-yl)-5,6,7,8-tetrahydroquinoline

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Daphnia magna

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Results and discussion

Effect concentrations
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
4.9 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility

Any other information on results incl. tables

At the start of the renewal periods (Day 0/Day 1), the analytically determined concentrations of GR-50-0572 in the test media (dilutions 1:100, 1:10, 1:4.6 and 1:2.2 of the undiluted filtrate with the loading rate 100 mg/L) were 0.33/0.49, 2.6/4.2, 6.8/9.1 and 13.5 mg/L, respectively (see analytical results and Table 3 in Appendix I). At the end of the renewal periods (Day 1/Day 2), the measured concentrations were 0.33/0.45, 2.6/3.7, 6.5/7.9 and 12.3 mg/L. GR-50-0572 was relatively stable, the analysed concentrations demonstrating between 87 and 100% stability over the 24 hour renewal period. Results of the biological-phase of the study were related to the mean measured exposure concentrations of the test item: Nominal Loading Rate [mg/L] Dilution Factor from the undiluted filtrate with the loading rate 100 mg/L Mean Measured Exposure Concentration of GR-50-0572 [mg/l] Control n.a.

After 48 hours of exposure, no further immobilized test organisms were determined in the control. At the test item concentration of dilution 1:100 an immobilization rate of 20% was determined. However, all immobilised daphnids at this concentration level were found in one single replicate. This result is considered an anomaly (e.g. vessel containing residual contamination from a previous test), given the observations in the next three highest test concentrations. At the dilution 1:46, 5% of the daphnids were found to be immobile. From the dilution 1:4.6 onwards all daphnids were found to be immobile. The following adverse effects besides immobility were observed: At the dilution 1:22 one daphnid showed reduced swimming activity. At the dilution 1:10 six animals were trapped at the water surface and all test animals showed reduced swimming activity. The 48-hour EC50 was calculated to be 4.9 mg/L with 95% confidence limits of 3.2 and 7.5 mg/L. The 48-hour NOEC of GR-50-0572 based on immobility was 3.2 mg/L. The 48-hour EC100 was 7.5 mg/L. No remarkable observations were made concerning the appearance of the test media (Table 3). All test media were clear solutions throughout the entire test duration. At the beginning and end of the test medium renewal periods, the pH of the test media was constantly 7.5 (Table 4). The dissolved oxygen concentrations in the test media and control were at least 8.2 mg/L (Table 5), and water temperature was maintained at 21 °C during the test (Table 6). The test is considered to be valid, as the guideline requirement that not more than 10% of the daphnids in the control should show immobilization or other signs of disease or stress (e.g., discoloration or unusual behavior such as trapping at the surface water) was fulfilled. Furthermore, the dissolved oxygen concentration at the end of the test was ≥3 mg/L in the control and test vessels.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The test item had acute toxic effects on Daphnia magna. The 48-hour EC50 was determined to be
4.9 mg/L with 95%-confidence limits of 3.2 and 7.5 mg/L based on mean measured exposure
concentrations.
– 24-hour EC50: 9.9 mg/L
(95% confidence limits: 7.5 and 13 mg/L)
– 24-hour EC0: 7.5 mg/L
– 24-hour EC100: 13 mg/L
– 48-hour EC50: 4.9 mg/L
(95% confidence limits: 3.2 and 7.5 mg/L)
– 48-hour EC0 and
48-hour NOEC: 3.2 mg/L
– 48-hour EC100: 7.5 mg/L
Executive summary:

The acute toxicity of the test item GR-50-0572 to Daphnia magna was determined in a 48-hour semi-static test according to the EU Commission Directive 92/69/EEC, Part C.2, the Commission Regulation (EC) No 440/2008, Part C.2, the OECD Guideline for Testing of Chemicals, No. 202 (2004), as well as according to the OPPTS Guideline No. 850.1010 (Public Draft, April 1996). Due to the low water solubility of the test item, a dispersion of the test item with the loading rate of 100 mg/L was continuously stirred at room temperature in the dark over 3 hours supported by 15 minutes ultrasonication. Then, the dispersion was filtered with reduced negative pressure. The dilutions 1:100, 1:46, 1:22, 1:10, 1:4.6 and 1:2.2 of the undiluted filtrate with the loading rate of 100 mg/L were used as test media. Additionally, a control was tested in parallel. The preparation of the test media was based on the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, 2000. The test was performed in a closed system (glass tubes completely filled with test medium and tightly sealed with glass stoppers) to avoid any loss of test item due to volatilization. In order to avoid a photolytic degradation of the test item, the test was performed as far as possible in the dark, in the event that the test substance my be susceptible to aqueous photolysis. At the start of the renewal periods (Day 0/Day 1), the analytically determined concentrations of GR-50-0572 in the test media (dilutions 1:100, 1:10, 1:4.6, 1:2.2 of the undiluted filtrate with the loading rate 100 mg/L) were 0.33/0.49, 2.6/4.2, 6.8/9.1 and 13.5 mg/L, respectively. At the end of the renewal periods (Day 1/Day 2), the measured concentrations were 0.33/0.45, 2.6/3.7, 6.5/7.9 and 12.3 mg/L. GR-50-0572 was relatively stable, the analysed concentrations demonstrating between 87 and 100% stability over the 24 hour renewal period. Nominal Loading Rate [mg/L] Dilution Factor from the undiluted filtrate with the loading rate 100 mg/L Mean Measured Exposure Concentration of GR-50-0572 [mg/l] Control n.a.

During the first 24 hours of the test, one immobilized test organism was determined in the control and the lowest test concentration at dilution 1:100. At the highest test concentration at dilution 1:2.2 all test animals were immobile. At all other test concentrations of dilutions 1:46, 1:22, 1:10 and 1:4.6 no immobile daphnids were observed. Furthermore, adverse effects were observed at the concentrations dilution 1:10 and 1:4.6, few daphnids were trapped at the water surface and all daphnids showed reduced swimming activity in both concentrations. After 48 hours of exposure, no further immobilized test organisms were determined in the control. At the test item concentration of dilution 1:100 an immobilization rate of 20% was determined. This result is considered an anomaly (e.g. vessel containing residual contamination from a previous test), given the observations in the next three highest test concentrations. At the dilution 1:46, 5% of the daphnids were found to be immobile. From the dilution 1:4.6 onwards all daphnids were found to be immobile. The following adverse effects besides immobility were observed: At the dilution 1:22 one daphnid showed reduced swimming activity. At the dilution 1:10 six animals were trapped at the water surface and all test animals showed reduced swimming activity. The biological test results (based on mean measured concentrations) were as follows: – 24-hour EC50: 9.9 mg/L (95% confidence limits: 7.5 and 13 mg/L) – 24-hour EC0: 7.5 mg/L – 24-hour EC100: 13 mg/L – 48-hour EC50: 4.9 mg/L (95% confidence limits: 3.2 and 7.5 mg/L) – 48-hour EC0 and 48-hour NOEC: 3.2 mg/L – 48-hour EC100: 7.5 mg/L The test is considered to be valid as the validity criteria were met: in the control, no daphnids showed immobilization or other signs of disease or stress and the dissolved oxygen concentration at the end of the test was ≥3 mg/L in all treatments.