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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Experimental data of test chemical
Justification for type of information:
Experimental data of test chemical is from peer reviewed journal
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: Refer below principle
Principles of method if other than guideline:
WoE report is prepared based on long term toxicity to aquatic invertebrates study:
2nd and 3rd
GLP compliance:
no
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
Details on test solutions
Following composition was used in the test and control preparations:
11 .76 g CaCl 2. 2H2O(A.R.)/I litre deionized water
4.93 g MgSO 4. 7H2O (A.R.)/I litre deionized water
2.59 g NaHCO 3 (A.R.)/1 litre deionized water
0.23 g KCl (A.R.)/1 litre deionized water.
25 mL of each solution was pipetted into a graduated flask and completed to I litre with deionized water. The amount of calcium and magnesium ions in this solution was 2.5 mM /L. The molar relationship of sodium to potassium ions was 10:1. This water was aerated up to the water saturation level and the pH value was
measured (8.0 + 0.2)
Test organisms (species):
Daphnia magna
Details on test organisms:
Details on test organisms
TEST ORGANISM
- Common name: Water flea
- Strain/clone: IRCHA strain
- Age of parental stock (mean and range, SD): 24 hrs old
- Feeding during test
- Food type: dry algae of the
Scenedesmus genus
- Amount: 9 g of feed were suspended in 1000 ml tap water and 2 ml of the suspension were added to each beaker.
- Frequency: daily
Test type:
semi-static
Water media type:
freshwater
Total exposure duration:
21 d
pH:
8
Nominal and measured concentrations:
Nominal
Details on test conditions:
Details on test conditions
TEST SYSTEM
- Test vessel: 4 test vessels
- Type : open (Covered with watch glasses )
- No. of organisms per vessel: 5
Reference substance (positive control):
not specified
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
14 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: 2nd study
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
91 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Basis of effects were reproduction rate and appearance of 1st offspring
Remarks on result:
other: 3rd study
Details on results:
2. No effect were observed on the reproduction rate of test organism at 14 mg/l.
3. No effect were observed on the reproduction rate of test organism at 91 mg/l.
Validity criteria fulfilled:
not specified
Conclusions:
2. After the exposure of test chemical with daphnia magna for 21 days effect were not observed at the concentration 14 mg/l. Thus NOEC was determine to be 14 mg/l. By considering this NOEC value it is concluded that test chemical is nontoxic to aquatic invertebrates and cannot be classified as per the CLP regulation.
3. After the exposure of test chemical with daphnia magna for 21 days no effects were observed on reproduction rate and appearance of 1st offspring at the concentration 91 mg/l.
Thus based on the overall studies, it was concluded that the test chemical was nontoxic to aquatic invertebrate and it cannot be classified as per the CLP classification criteria.
Executive summary:

Various long term studies available for the test chemical were reviewed to determine the toxic nature of test chemical on the growth and mobility of aquatic invertebrates. The studies are as mentioned below:

In the first study (from peer reviewed journal) toxicity was measured. Aim of this study is to determine the effect of test chemical on the 24 hrs old Daphnia Magna by providing the exposure period of 21 days. Effect were measured on the basis of reproduction rate inhibition. Test conducted in Equivalent to OECD 211. This experiment was performed on 24 hrs old Daphnia magna (IRCHA strain) and synthetic fresh water was used as medium in this medium The amount of calcium and magnesium ions was 2.5mmol/L. Before preparing the dilution series the test chemical was fully dissolved in water using magnetic stirrers. From the stock solution of the substance to be tested, graduated dilutions with dilution water were produced in the concentration range in which effects were to be expected in accordance with the results from the acute 24 h Daphnia test. Four parallel test vessels per concentration level and the controls comprising at least four vessels were filled with 24 h-old Daphnia 1 animal/50 ml and this meant 20 test animals (1 litre) per concentration level and COD of 15-20 mg/L. The semi-static procedure was used in this experiment the parent animals in the test and control vessels had to be pipetted 3 times a week into freshly prepared test and control media in each case at the corresponding concentration level. Then, the pH value and the oxygen concentration were measured in two test vessels per concentration level and the photo period 9 hrs light and 16 hrs dark. The validity criteria were reproduction rate per parent animal after 21 days, in the case of the test preparation in the beakers, was 88.8 offspring (SD = 13.1; coefficient of variation = 14.8%), The "parent animal mortality" after 21 days was 7.1% in the case of the test preparation in beakers and 9.1% in bottles, the pH always remained in the neutral to subalkaline range. After the exposure of test chemical with daphnia magna for 21 days effect were not observed at the concentration 14 mg/l. Thus NOEC was determine to be 14 mg/l. By considering this NOEC value it is concluded that test chemical is nontoxic to aquatic invertebrates and cannot be classified as per the CLP regulation. 

Similarly the above study was supported by the second study from peer reviewed journal. Aim of this study was to determine the effect of test chemical on the 24 hrs old Daphnia Magna by providing the exposure period of 21 days. Effect were measured on the basis of reproduction rate inhibition and appearance of 1st offspring. Test conducted in Equivalent to OECD 211. This experiment was performed on 24 hrs old Daphnia magna (IRCHA strain) and synthetic fresh water was used as medium in this medium The amount of calcium and magnesium ions was 2.5mmol/L. Before preparing the dilution series the test chemical was fully dissolved in water using magnetic stirrers. From the stock solution of the substance to be tested, graduated dilutions with dilution water were produced in the concentration range in which effects were to be expected in accordance with the results from the acute 24 h Daphnia test. Four parallel test vessels per concentration level and the controls comprising at least four vessels were filled with 24 h-old Daphnia 1 animal/50 ml and this meant 20 test animals (1 litre) per concentration level and COD of 15-20 mg/L. The semi-static procedure was used in this experiment the parent animals in the test and control vessels had to be pipetted 3 times a week into freshly prepared test and control media in each case at the corresponding concentration level. Then, the pH value and the oxygen concentration were measured in two test vessels per concentration level and the photo period 9 hrs light and 16 hrs dark. The validity criteria were reproduction rate per parent animal after 21 days, in the case of the test preparation in the beakers, was 88.8 offspring (SD = 13.1; coefficient of variation = 14.8%), The "parent animal mortality" after 21 days was 7.1% in the case of the test preparation in beakers and 9.1% in bottles, the pH always remained in the neutral to subalkaline range. After the exposure of test chemical with daphnia magna for 21 days no effects were observed on reproduction rate and appearance of 1st offspring at the concentration 91 mg/l. By considering this NOEC value it is concluded that test chemical is nontoxic to aquatic invertebrates and cannot be classified as per the CLP regulation. 

Thus based on the overall studies, it was concluded that the test chemical was nontoxic to aquatic invertebrate and it cannot be classified as per the CLP classification criteria.

Description of key information

2. After the exposure of test chemical with daphnia magna for 21 days effect were not observed at the concentration 14 mg/l. Thus NOEC was determine to be 14 mg/l. By considering this NOEC value it is concluded that test chemical is nontoxic to aquatic invertebrates and cannot be classified as per the CLP regulation.  

3. After the exposure of test chemical with daphnia magna for 21 days no effects were observed on reproduction rate and appearance of 1st offspring at the concentration 91 mg/l.

Thus based on the overall studies, it was concluded that the test chemical was nontoxic to aquatic invertebrate and it cannot be classified as per the CLP classification criteria.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
14 mg/L

Additional information

Various long term studies available for the test chemical and structually and functionally similar read across chemical were reviewed to determine the toxic nature of test chemical on the growth and mobility of aquatic invertebrates. The studies are as mentioned below:

In the first study (from peer reviewed journal) toxicity was measured. Aim of this study is to determine the effect of test chemical on the 24 hrs old Daphnia Magna by providing the exposure period of 21 days. Effect were measured on the basis of reproduction rate inhibition. Test conducted in Equivalent to OECD 211. This experiment was performed on 24 hrs old Daphnia magna (IRCHA strain) and synthetic fresh water was used as medium in this medium The amount of calcium and magnesium ions was 2.5mmol/L. Before preparing the dilution series the test chemical was fully dissolved in water using magnetic stirrers. From the stock solution of the substance to be tested, graduated dilutions with dilution water were produced in the concentration range in which effects were to be expected in accordance with the results from the acute 24 h Daphnia test. Four parallel test vessels per concentration level and the controls comprising at least four vessels were filled with 24 h-old Daphnia 1 animal/50 ml and this meant 20 test animals (1 litre) per concentration level and COD of 15-20 mg/L. The semi-static procedure was used in this experiment the parent animals in the test and control vessels had to be pipetted 3 times a week into freshly prepared test and control media in each case at the corresponding concentration level. Then, the pH value and the oxygen concentration were measured in two test vessels per concentration level and the photo period 9 hrs light and 16 hrs dark. The validity criteria were reproduction rate per parent animal after 21 days, in the case of the test preparation in the beakers, was 88.8 offspring (SD = 13.1; coefficient of variation = 14.8%), The "parent animal mortality" after 21 days was 7.1% in the case of the test preparation in beakers and 9.1% in bottles, the pH always remained in the neutral to subalkaline range. After the exposure of test chemical with daphnia magna for 21 days effect were not observed at the concentration 14 mg/l. Thus NOEC was determine to be 14 mg/l. By considering this NOEC value it is concluded that test chemical is nontoxic to aquatic invertebrates and cannot be classified as per the CLP regulation. 

Similarly the first study was supported by the second study from peer reviewed journal. Aim of this study was to determine the effect of test chemical on the 24 hrs old Daphnia Magna by providing the exposure period of 21 days. Effect were measured on the basis of reproduction rate inhibition and appearance of 1st offspring. Test conducted in Equivalent to OECD 211. This experiment was performed on 24 hrs old Daphnia magna (IRCHA strain) and synthetic fresh water was used as medium in this medium The amount of calcium and magnesium ions was 2.5mmol/L. Before preparing the dilution series the test chemical was fully dissolved in water using magnetic stirrers. From the stock solution of the substance to be tested, graduated dilutions with dilution water were produced in the concentration range in which effects were to be expected in accordance with the results from the acute 24 h Daphnia test. Four parallel test vessels per concentration level and the controls comprising at least four vessels were filled with 24 h-old Daphnia 1 animal/50 ml and this meant 20 test animals (1 litre) per concentration level and COD of 15-20 mg/L. The semi-static procedure was used in this experiment the parent animals in the test and control vessels had to be pipetted 3 times a week into freshly prepared test and control media in each case at the corresponding concentration level. Then, the pH value and the oxygen concentration were measured in two test vessels per concentration level and the photo period 9 hrs light and 16 hrs dark. The validity criteria were reproduction rate per parent animal after 21 days, in the case of the test preparation in the beakers, was 88.8 offspring (SD = 13.1; coefficient of variation = 14.8%), The "parent animal mortality" after 21 days was 7.1% in the case of the test preparation in beakers and 9.1% in bottles, the pH always remained in the neutral to subalkaline range. After the exposure of test chemical with daphnia magna for 21 days no effects were observed on reproduction rate and appearance of 1st offspring at the concentration 91 mg/l. By considering this NOEC value it is concluded that test chemical is nontoxic to aquatic invertebrates and cannot be classified as per the CLP regulation. 

Thus based on the overall studies, it was concluded that the test chemical was nontoxic to aquatic invertebrate and it cannot be classified as per the CLP classification criteria.