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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Endpoint:
short-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 with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
not specified
Analytical monitoring:
yes
Details on sampling:
- The concentrations of test substance were measured at the beginning of the test and after 24h; dissolved oxygen and pH were measured after 24 and 48h.
Vehicle:
no
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Strain/clone: Daphnia magna
- Source: laboratory culture in tap water filtrated by activated carbon (pH 7.4-7.9, Ca/Mg = 3.5-4-1, Na/K = 5.5-6.4, hardness 20-32).
- Feeding during test: no.

ACCLIMATION
- Acclimation period: not specified.
- Acclimation conditions: same as test.
- Type and amount of food: Chlorella vulgaris
- Feeding frequency: 3.2 - 4.8E5 cells/mL/day (0.07 - 0.10 mgC/Daphnia/day)
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
20 - 32
Test temperature:
20 ± 1ºC
pH:
7.4 - 7.9
Dissolved oxygen:
8.0-9.0 ppm
Nominal and measured concentrations:
5 concentrations with a separation factor of 1.8. No further details provided.
Details on test conditions:
TEST SYSTEM
- Test vessel: 100 mL glass beaker.
- Renewal rate of test solution (frequency): 24h
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water filtrated by activated carbon.

OTHER TEST CONDITIONS
- Adjustment of pH: no.
- Photoperiod: continuous darkness.
Reference substance (positive control):
not specified
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
31.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
32.03 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: no.
Reported statistics and error estimates:
EC50 and LC50 were calculated by the probit method based on the initial concentrations, because the decrease was less than 20% of the initial concentration.

Table 1. EC50 and LC50 values and their variations.

Chemical

24h

48h

Vanillin (n=3)

EC50 (CV)

LC50 (CV)

EC50 (CV)

LC50 (CV)

60.0 ± 7.26

(12.1)

71.6 ± 8.84

(12.3)

31.50 ± 3.96

(12.6)

32.03 ± 3.88

(12.1)

Validity criteria fulfilled:
yes
Remarks:
The validity parameters never exceeded the limits allowed by the OECD guideline during the test.
Conclusions:
Under test conditions, the 48h-EC50 of the test item in daphnia was determined to be 31.5 mg/L.
Executive summary:

An acute immobilisation test was performed with the test item on Daphnia magna, according to OECD 202 (no GLP). Twenty daphnids, divided into 4 groups of 5 animals each, were used in each of 5 test concentrations (separation factor 1.8) and for the control group, under semi-static conditions. The concentration of test substance was measured by HPLC at the start of the test and after 24h, and the pH and oxygen concentrations were measured after 24h and 48h. All validity criteria were met. Under test conditions, the 48h-EC50 of the test item in daphnia was determined to be 31.5 mg/L.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See 'Attached justification'.
Reason / purpose for cross-reference:
read-across source
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
31.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Read-across from analogue.
Validity criteria fulfilled:
yes
Conclusions:
Based on the available information for the read-across approach, the target substance is deemed to have a 48h-EC50 = 31 .5 mg/L in daphnia.
Executive summary:

An acute immobilisation test was performed with the analogue substance vanillin on Daphnia magna, according to OECD 202 (no GLP). Twenty daphnids, divided into 4 groups of 5 animals each, were used in each of 5 test concentrations (separation factor 1.8) and for the control group, under semi-static conditions. The concentration of test substance was measured by HPLC at the start of the test and after 24h, and the pH and oxygen concentrations were measured after 24h and 48h. All validity criteria were met. Under test conditions, the 48h-EC50 of the test item in daphnia was determined to be 31.5 mg/L. Based on the available information for the read-across approach, the target substance is deemed to have a 48h-EC50 = 31 .5 mg/L in daphnia.

Endpoint:
short-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:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
yes
Remarks:
10:14-h light:dark photoperiod, no details on analytical monitoring.
GLP compliance:
not specified
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source: the tested chemicals were synthesized by college of chemistry and chemical engineering of Nanjiing University. The purity was monitored by HPLC to assure that no interference peak had occurred.
Analytical monitoring:
not specified
Vehicle:
not specified
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: daphnia
- Source: The Daphnia magna used in the experiments were obtained from a culture maintained at Nanjing University.
- Feeding during test: no.

ACCLIMATION
- Acclimation period: not specified.
- Acclimation conditions: same as test or not.
- Type and amount of food: green algae (Chlorellapyrenoidoso)
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
99.4 mg/L expressed as CaCO3
Test temperature:
22 ± 1ºC
pH:
7.4
Dissolved oxygen:
> 8.0 mg/L
Nominal and measured concentrations:
nominal.
Details on test conditions:
TEST SYSTEM
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated tap water (dissolved oxygen concentration > 8.0 mg/L; pH = 7.4; hardness = 99.4 mg/L expressed as CaCO3) was used for maintaining stock cultures and was used as the test medium in all experiments.

RANGE-FINDING STUDY
- Test concentrations: the concentration range was determined from range-finding tests. No further details.
Reference substance (positive control):
not specified
Duration:
48 h
Dose descriptor:
other: log 48h-EC50
Effect conc.:
-3.499 mol/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
48.23 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: not specified.
Reported statistics and error estimates:
The results of the three assays were combined and probit analysis was used to determine the median immobilization concentration of the test item (EC50).
Validity criteria fulfilled:
yes
Remarks:
Control survival was always 100%, dissolved oxygen concentration was > 8 mg/L.
Conclusions:
The log 48h-EC50 of the test item in daphnia was reported to be -3.499 mol/L, which corresponds to an EC50 of 48.23 mg/L.
Executive summary:

An acute immobilisation test was performed with the test item on Daphnia magna, by a method similar to OECD 202 (no GLP). A preliminary study was performed to determine the concentration of the main test. Then, the daphnids, divided into 3 groups of 10 animals each, were used in three separate assays involving seven different concentrations of test item and dilution water controls. Based on the results of the test, the log 48h-EC50 of the test item in daphnia was reported to be -3.499 mol/L, which corresponds to an EC50 of 48.23 mg/L.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See 'Attached justification'.
Reason / purpose for cross-reference:
read-across source
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
48.23 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Read-across from analogue.
Validity criteria fulfilled:
yes
Conclusions:
Based on the available information for the read-across approach, the target substance is deemed to have a 48h-EC50 = 48.23 mg/L in daphnia.
Executive summary:

An acute immobilisation test was performed with the analogue substance vanillin on Daphnia magna, by a method similar to OECD 202 (no GLP). A preliminary study was performed to determine the concentration of the main test. Then, the daphnids, divided into 3 groups of 10 animals each, were used in three separate assays involving seven different concentrations of test item and dilution water controls. Based on the results of the test, the log 48h-EC50 of the test item in daphnia was reported to be -3.499 mol/L, which corresponds to an EC50 of 48.23 mg/L. Based on the available information for the read-across approach, the target substance is deemed to have a 48h-EC50 = 48.23 mg/L in daphnia.

Description of key information

Weight of evidence: Based on two studies from the analogue substance vanillin, and following a worst-case scenario approach, the 48h-EC50 of the test item in daphnia is deemed to be 31.5 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
31.5 mg/L

Additional information

Weight of evidence. Based on the available information for the read-across approach, the 48h-EC50 of the test item in daphnia is deemed to be 31.5 mg/L (worst case).

An acute immobilisation test was performed with the analogue substance vanillin on Daphnia magna, according to OECD 202 (no GLP). Twenty daphnids, divided into 4 groups of 5 animals each, were used in each of 5 test concentrations (separation factor 1.8) and for the control group, under semi-static conditions. The concentration of test substance was measured by HPLC at the start of the test and after 24h, and the pH and oxygen concentrations were measured after 24h and 48h. All validity criteria were met. Under test conditions, the 48h-EC50 of the test item in daphnia was determined to be 31.5 mg/L. Based on the available information for the read-across approach, the target substance is deemed to have a 48h-EC50 = 31 .5 mg/L in daphnia. Another acute immobilisation test was performed with the analogue substance vanillin on Daphnia magna, by a method similar to OECD 202 (no GLP). A preliminary study was performed to determine the concentration of the main test. Then, the daphnids, divided into 3 groups of 10 animals each, were used in three separate assays involving seven different concentrations of test item and dilution water controls. Based on the results of the test, the log 48h-EC50 of the test item in daphnia was reported to be -3.499 mol/L, which corresponds to an EC50 of 48.23 mg/L. Based on the available information for the read-across approach, the target substance is deemed to have a 48h-EC50 = 48.23 mg/L in daphnia.