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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Experimental test result performed according to the OECD test guideline.
Qualifier:
according to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
GLP compliance:
no
Analytical monitoring:
yes
Details on sampling:
The solution of test chemical was prepared by dissolving 100 mg of test chemical in 100 ml of Adams medium to get the final concentration of 1000 mg/L. Stock solution was then analytically determined.The final solubility value obtained after analytical detection was 296.79 mg/L.The remaining test solutions were prepared by dilution from the stock solution. Thus, test chemical concentrations used for the study were 0, 0.5, 1, 2, 4 and 8 mg/L, respectively.
Vehicle:
no
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water Flea
- Strain/clone: Straus
- Length at study initiation (length definition, mean, range and SD): 0.37 cm
- Source: Eggs of Daphnia magna were obtained from MicroBio tests Kleimoer 15B-9030 MARIAKERKE (GENT) BELGIUM and maintained in the Laboratory, Nagpur.
- Maintenance: A population of parthenogenetic females of synchronized age structure has been maintained for more than 2 years in the test facility under constant temperature conditions (18 to 22 °C) at a 16 : 8 hour light-dark photoperiod (illumination: < 1000 lux). The culture media (Adams medium') was partly renewed once a week. The Daphnia were exclusively fed with unicellular green algae (Selenestrum capricornutum). Media renewal of Daphnia culture was done twice a week and pH, DO, temperature was recorded daily
- Feeding during test: yes
- Food type: Test organism was fed with Selenestrum capricornutum.
- Frequency: Test organism was fed with Selenestrum capricornutum thrice a week.



Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Hardness:
200 mg/l as CaCO3
Test temperature:
18 – 22°C
pH:
7.8
Dissolved oxygen:
6.3 to 8.3 mg/l
Nominal and measured concentrations:
Nominal concentrations: 0, 0.5, 1, 2, 4, 8 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass beaker
- Material, size, headspace, fill volume: 100 mL glass beaker
- No. of organisms per vessel: 1 test organism
- No. of vessels per concentration (replicates): 10 replicates
- No. of vessels per control (replicates): 10 replicates

OTHER TEST CONDITIONS
- Photoperiod: 16 hour light and 8 hour dark
- Light intensity: 1000 – 1500 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Reproduction rate and the mobility behaviour / mortality rate of parent Daphnia was assessed at least three times a week.

TEST CONCENTRATION
- Test concentrations: Test chemical concentrations used for the study were 0, 0.5, 1, 2, 4 and 8 mg/L, respectively.
Reference substance (positive control):
no
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
0.558 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Key result
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
0.198 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction

The mortality in the control groups did not exceeded 20% percent.

Validity criteria fulfilled:
yes
Remarks:
The mortality rate < 20% (end of the test) Living offspring produced per parent Daphnia surviving at the end of the test was ≥ 60 in the controls. The DO concentration remained > 3 mg/L. The pH range 6-9. Water hardness >140 mg/L (as CaCO3).
Conclusions:
Based on the reproduction of the test organism Daphnia magna due to the exposure of test chemical, the 21 days EC50 and EC10 value was determined to be 0.5581 mg/l and 0.198 mg/L (nominal concentration).
Executive summary:

Chronic toxicity to aquatic invertebrate study was conducted for 21 days for assessing the effect of test chemical on aquatic invertebrates. The study was performed following the OECD Guideline 211 (Daphnia magna Reproduction Test) under semi-static conditions. The solution of test chemical was prepared by dissolving 100 mg of test chemical in 100 ml of Adams medium to get the final concentration of 1000 mg/L. Test chemical concentrations were verified analytically by UV-Vis Spectrophotometer and the final solubility value obtained after analytical detection was 296.79 mg/l. The remaining test solutions were prepared by dilution from the stock solution. Thus, test chemical concentrations used for the study were 0 (control), 0.5, 1, 2, 4 and 8 mg/L, respectively. Daphnia magna (water flea) of length 0.37 cm was used as a test organism. A population of parthenogenetic females of synchronized age structure has been maintained for more than 2 years in the test facility under constant temperature conditions (18 to 22 °C) at a 16 : 8 hour light-dark photoperiod (illumination: < 1000 lux). The culture media (Adams medium') was partly renewed once a week. The Daphnia were exclusively fed with unicellular green algae (Selenestrum capricornutum) thrice a week. Total 50 test organisms were exposed to five test chemical concentrations (n = 10) in 100 ml glass beaker. In addition to this, control test vessel was also setup during the study. Test vessels were then placed at temperature of 18 – 22°C, hardness 200 mg/l as CaCO3, pH 7.8, dissolved oxygen 6.3 to 8.3 mg/l and under a photoperiod of 16 hour light and 8 hour dark with 1000 – 1500 lux light intensity. Reproduction rate and the mobility behaviour / mortality rate of parent Daphnia was assessed at least three times a week. The test concentrations were measured and was observed be maintained within 80-120% of nominal concentration, thus, effect concentrations (EC) would be evaluated as the nominal concentrations. The mortality in the control groups did not exceeded 20% percent. Thus, the validity criterion of the test has been fulfilled. On the basis of the effect of test chemical on the reproduction of the test organism Daphnia magna,

the 21 days EC50 and EC 10 value was determined to be 0.5581 mg/l and 0.198 mg/L respectively ( nominal concentration). Thus, test chemical was considered as toxic to aquatic invertebrates and hence, considered to be classified in 'aquatic chronic category 2' as per the CLP classification criteria.

Description of key information

Chronic toxicity to aquatic invertebrate study was conducted for 21 days for assessing the effect of test chemical on aquatic invertebrates (Experimental study report, 2019). The study was performed following the OECD Guideline 211 (Daphnia magna Reproduction Test) under semi-static conditions. The solution of test chemical was prepared by dissolving 100 mg of test chemical in 100 ml of Adams medium to get the final concentration of 1000 mg/L. Test chemical concentrations were verified analytically by UV-Vis Spectrophotometer and the final solubility value obtained after analytical detection was 296.79 mg/l. The remaining test solutions were prepared by dilution from the stock solution. Thus, test chemical concentrations used for the study were 0 (control), 0.5, 1, 2, 4 and 8 mg/L, respectively. Daphnia magna (water flea) of length 0.37 cm was used as a test organism. A population of parthenogenetic females of synchronized age structure has been maintained for more than 2 years in the test facility under constant temperature conditions (18 to 22 °C) at a 16 : 8 hour light-dark photoperiod (illumination: < 1000 lux). The culture media (Adams medium') was partly renewed once a week. The Daphnia were exclusively fed with unicellular green algae (Selenestrum capricornutum) thrice a week. Total 50 test organisms were exposed to five test chemical concentrations (n = 10) in 100 ml glass beaker. In addition to this, control test vessel was also setup during the study. Test vessels were then placed at temperature of 18 – 22°C, hardness 200 mg/l as CaCO3, pH 7.8, dissolved oxygen 6.3 to 8.3 mg/l and under a photoperiod of 16 hour light and 8 hour dark with 1000 – 1500 lux light intensity. Reproduction rate and the mobility behaviour / mortality rate of parent Daphnia was assessed at least three times a week. The test concentrations were measured and was observed be maintained within 80-120% of nominal concentration, thus, effect concentrations (EC) would be evaluated as the nominal concentrations. The mortality in the control groups did not exceeded 20% percent. Thus, the validity criterion of the test has been fulfilled. On the basis of the effect of test chemical on the reproduction of the test organism Daphnia magna, the 21 days EC50 and EC 10 value was determined to be 0.5581 mg/l and 0.198 mg/L respectively (nominal concentration). Thus, test chemical was considered as toxic to aquatic invertebrates and hence, considered to be classified in 'aquatic chronic category 2' as per the CLP classification criteria.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
0.198 mg/L

Additional information

Chronic toxicity to aquatic invertebrate study was conducted for 21 days for assessing the effect of test chemical on aquatic invertebrates (Experimental study report, 2019). The study was performed following the OECD Guideline 211 (Daphnia magna Reproduction Test) under semi-static conditions. The solution of test chemical was prepared by dissolving 100 mg of test chemical in 100 ml of Adams medium to get the final concentration of 1000 mg/L. Test chemical concentrations were verified analytically by UV-Vis Spectrophotometer and the final solubility value obtained after analytical detection was 296.79 mg/l. The remaining test solutions were prepared by dilution from the stock solution. Thus, test chemical concentrations used for the study were 0 (control), 0.5, 1, 2, 4 and 8 mg/L, respectively. Daphnia magna (water flea) of length 0.37 cm was used as a test organism. A population of parthenogenetic females of synchronized age structure has been maintained for more than 2 years in the test facility under constant temperature conditions (18 to 22 °C) at a 16 : 8 hour light-dark photoperiod (illumination: < 1000 lux). The culture media (Adams medium') was partly renewed once a week. The Daphnia were exclusively fed with unicellular green algae (Selenestrum capricornutum) thrice a week. Total 50 test organisms were exposed to five test chemical concentrations (n = 10) in 100 ml glass beaker. In addition to this, control test vessel was also setup during the study. Test vessels were then placed at temperature of 18 – 22°C, hardness 200 mg/l as CaCO3, pH 7.8, dissolved oxygen 6.3 to 8.3 mg/l and under a photoperiod of 16 hour light and 8 hour dark with 1000 – 1500 lux light intensity. Reproduction rate and the mobility behaviour / mortality rate of parent Daphnia was assessed at least three times a week. The test concentrations were measured and was observed be maintained within 80-120% of nominal concentration, thus, effect concentrations (EC) would be evaluated as the nominal concentrations. The mortality in the control groups did not exceeded 20% percent. Thus, the validity criterion of the test has been fulfilled. On the basis of the effect of test chemical on the reproduction of the test organism Daphnia magna, the 21 days EC50 and EC 10 value was determined to be 0.5581 mg/l and 0.198 mg/L respectively ( nominal concentration). Thus, test chemical was considered as toxic to aquatic invertebrates and hence, considered to be classified in 'aquatic chronic category 2' as per the CLP classification criteria.