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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
Study period:
2017-12-19 to 2018-01-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
Batch No.: 20170214
Purity: >99%
Analytical monitoring:
yes
Details on sampling:
Samples were taken for analysis from the freshly prepared solutions and the old solution at least twice a week.
Vehicle:
no
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Age at study initiation: less than 24 hours old
- Source: They should not be the first brood progeny. They were derived from a healthy stock (i.e. showing no signs of stress such as high mortality, presence of males and ephippia, delay in the production of the first brood, discolored animals, etc.).
- Feeding during test
- Food type: 0.1~ 0.2 mg C/Daphnia/Day

ACCLIMATION
- Acclimation conditions (same as test or not): The stock animals were maintained in culture conditions (light, temperature, and medium) similar to those to be used in the test.
- Type and amount of food: concentrated algal suspension
- Light: 16 hours photoperiod daily, 8 hours dark
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
21 d
Hardness:
170 mg/L ~ 200 mg/L (as CaCO3)
Test temperature:
19.1 ~ 20.2 ℃
pH:
7.96 ~ 8.26
Dissolved oxygen:
8.24 ~ 9.38 mg/L
Nominal and measured concentrations:
Norminal: 10 mg/L
Measured: 0.0131 mg/L (The overall arithmetic mean of geometrical mean of each batch determined concentration)
Details on test conditions:
TEST SYSTEM
- Test vessel: 200 ~ 250 mL conical flask
- Aeration: Before usage, the water was aerated for more than 24 hours to attain dissolved oxygen saturation.
- Renewal rate of test solution (frequency/flow rate): every 24 h
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): one
- No. of vessels per control (replicates): one

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: treated with Aquapro Pure Water System
- Total organic carbon: 0.046 mg/L, < 2 mg/L
- Intervals of water quality measurement: The indicators of the test water should be inspected externally by a qualified company once a year, there were no indicators affecting the test quality when last checked.

OTHER TEST CONDITIONS
- Photoperiod: 16 hr light (1000 - 1500 lux for cool white light corresponds close to the recommended light intensity 15-20 μE•m-2•s-1): 8 hr dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : The offspring produced by each parent animal were removed and counted daily from the appearance of the first brood. Mortality among the parent animals were recorded preferably daily. Reproductive output per surviving parent animal, i.e. number of living offspring produced during the test per surviving parent, were recorded. The length of the living parent animals (i.e. body length excluding the anal spine) at the end of the test were measured.

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 10 mg/L
- Results used to determine the conditions for the definitive study: The no observed effect concentration was about 10 mg/L (nominal concentration).
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.013 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Details on results:
During the 21 days exposure period, no death and visible toxic signs were observed in the control group and test group.
Total number of juveniles of each parent, body length, first brood time, batch number of each parent, Juveniles of the first brood of each parent were analysis by a two-sided Student T-test using a 5% significance level to obtain the no observed effect concentration (NOEC). The P value of above item in test group was higher than 5%, so there was no significant difference between test group and control group.
The concentrations of test item were determined in samples of test media by HPLC-MS/MS method. The results showed that for the test solutions of 10 mg/L, the arithmetic mean determined concentration in fresh media was 0.0213 mg/L. The arithmetic mean determined concentration in old media was 0.0084 mg/L. The concentration in old solution was 39.4% of the fresh concentrations. The overall arithmetic mean of geometrical mean of each batch determined concentration was 0.0131 mg/L.
Results with reference substance (positive control):
The Recently EC50-24 h of the potassium dichromate to Daphnia was 1.67 mg/L, 95% confidences were 1.43-1.96 mg/L
Validity criteria fulfilled:
yes
Conclusions:
The 21-day NOEC for all the parameters, such as total juveniles of each parent, body length, first brood time, batch number of each parent, Juveniles of the first brood of each parent were 0.0131 mg/L.
Executive summary:

A Daphnia magna Reproduction Test of the test substance was conducted with Daphnia magna over 21 days exposure period according to OECD Guideline 211.

Based on the results of the preliminary test, the definitive test was carried out at concentration of 10 mg/L (nominal concentration). The actual concentrations of test solutions were measured by HPLC-MS/MS method. A concurrent blank control was performed in parallel. 10 daphnias were used for the test group and the control group. 10 animals individually held at test concentration and control was used. Based on the results of the preliminary test, a semi-static system renewed at 24 h with solution was used in the definitive test.

 

During the 21 days exposure period, no death and visible toxic signs were observed in the control group and test group.

The concentrations of test item were determined in samples of test media by HPLC-MS/MS method. The results showed that for the test solutions of 10 mg/L, the arithmetic mean determined concentration in fresh media was 0.0213 mg/L. The arithmetic mean determined concentration in old media was 0.0084 mg/L. The concentration in old solution was 39.4% of the fresh concentrations. The overall arithmetic mean of geometrical mean of each batch determined concentration was 0.0131 mg/L.

Total number of juveniles of each parent, body length, first brood time, batch number of each parent, Juveniles of the first brood of each parent were analysis by a two-sided Student T-test using a 5% significance level to obtain the no observed effect concentration (NOEC). The P value of above item in test group was higher than 5%, so there was no significant difference between test group and control group.

 

The 21-day NOEC for all the parameters, such as total juveniles of each parent, body length, first brood time, batch number of each parent, Juveniles of the first brood of each parent were 0.0131 mg/L.

Description of key information

The 21-day NOEC for all the parameters, such as total juveniles of each parent, body length, first brood time, batch number of each parent, Juveniles of the first brood of each parent were 0.0131 mg/L (the arithmetic mean of geometrical mean of each batch determined concentration).

Key value for chemical safety assessment

Additional information

A Daphnia magna Reproduction Test of the test substance was conducted with Daphnia magna over 21 days exposure period according to OECD Guideline 211.

Based on the results of the preliminary test, the definitive test was carried out at concentration of 10 mg/L (nominal concentration). The actual concentrations of test solutions were measured by HPLC-MS/MS method. A concurrent blank control was performed in parallel. 10 daphnias were used for the test group and the control group. 10 animals individually held at test concentration and control was used. Based on the results of the preliminary test, a semi-static system renewed at 24 h with solution was used in the definitive test.

During the 21 days exposure period, no death and visible toxic signs were observed in the control group and test group.

The concentrations of test item were determined in samples of test media by HPLC-MS/MS method. The results showed that for the test solutions of 10 mg/L, the arithmetic mean determined concentration in fresh media was 0.0213 mg/L. The arithmetic mean determined concentration in old media was 0.0084 mg/L. The concentration in old solution was 39.4% of the fresh concentrations. The overall arithmetic mean of geometrical mean of each batch determined concentration was 0.0131 mg/L.

Total number of juveniles of each parent, body length, first brood time, batch number of each parent, Juveniles of the first brood of each parent were analysis by a two-sided Student T-test using a 5% significance level to obtain the no observed effect concentration (NOEC). The P value of above item in test group was higher than 5%, so there was no significant difference between test group and control group.

The 21-day NOEC for all the parameters, such as total juveniles of each parent, body length, first brood time, batch number of each parent, Juveniles of the first brood of each parent were 0.0131 mg/L.