methyl-bis(2-arylpropyl)dihydro-heteropolycycle

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2020-03-20- 2020-06-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: OECD series on testing and assessment number 23 (Second Edition), Guidance Document on Aqueous-Phase Aquatic Toxicity Testing of Difficult Test Chemicals. Paris: OECD, Adopted on February 8, 2019.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

liquid

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

The test solutions of all test groups were filtered with 0.45 µm aqueous phase polyether sulfone (PES) filter membranes (the first 5 mL - 10 mL filtrate were discarded) before testing. The samples were analyzed immediately.

Test solutions

Vehicle:

no

Details on test solutions:

Dechlorinated tap water was used in the test. The total hardness of test water was 115 mg/L ( expressed as CaCO3) and the pH was 8.29.

0.50 g test substance was weighed into a 5 L - vessel and 5000 mL test water was added to obtain the nominal concentration of 100 mg/L test suspension. The test suspension was stirred with a magnetic stirrer for about 24 h. Then the mixture was filtered through 0.45 µm aqueous phase polyether sulfone (PES) filter membranes and discarded the insoluble particles, and the nominal concentration of 100 mg/L saturated solution (100%LS) was obtained and used in the test directly. The test stock solution was prepared in triplicate according to the mentioned above.
1200 mL, 1620 mL, 2192 mL and 2960 mL stock solution were transferred into 5 L- vessels and diluted with 2800 mL, 2380 mL, 1808 mL and 1040 mL test water respectively, then the concentrations of 30.0%LS, 40.5%LS, 54.8%LS and 74.0%LS test solutions were obtained and used in the definitive test directly. 4000mL stock solution was transfened into a 5 L -vessel, it was used as I 00%LS test group in the definitive test.

Test organisms

Test organisms (species):

other: Rare Minnow (Gobiocypris rarus)

Details on test organisms:

The fish were bred in the test laboratory. The batch number of Rare Minnow (Gobiocypris rarus) was FGr20191106-1115. Before the start of the test, Rare Minnow (Gobiocypris rarus) were acclimated for 68 days under the domestication conditions (water quality: dechlorinated tap water, temperature: 23 °C ± 2 °C, photoperiod: 14 h light / 10 h darkness). The dissolved oxygen concentration during acclimation was kept above 80% of the air saturation value. The fish were fed on workday per week until 24 hours before the start of the test. The mortality was 0% during the 7 days prior to the start of the test, which met the requirement of mortalities being less than 5% of the population.

Total number of test fish
42 fish ( detennination of the sex of fish was not required.)

Study design

Test type:

semi-static

Water media type:

other: Dechlorinated tap water

Limit test:

no

Total exposure duration:

96 h

Test conditions

Hardness:

115 mg/L (expressed as CaCO3)

Test temperature:

21.6 °C - 24.7 °C

pH:

The test was perfomed without adjustment of pH and the pH was in the range of 7.81 -8.32 during the test period.

Dissolved oxygen:

The test solutions were not aerated during the exposure. The dissolved oxygen concentration in the test solutions during the test was kept at least 60% of the air saturation value. The dissolved oxygen was in the range of 77% - 101 %.

Nominal and measured concentrations:

30.0%LS, 40.5%LS, 54.8%LS, 74.0%LS and 100%LS (LS= Limit Solution)
Time-weighted means of measured concentrations of test groups: 0.473 mg/L, 0.648 mg/L, 0.878 mg/L, 1.18 mg/L and 1.66 mg/L

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

1.4 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

1.18 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 3

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

1.66 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

The mortality of the control group was 0% at the end of the test, which met the validity criterion that the mortality should not less than l 0%. The dissolved oxygen concentration in the test solutions was 77% - 101%.

Conclusions:

Under the test condition of this study, the acute toxicity test of test substance to Rare Minnow (Gobiocypris rarus) was perfonned as definitive test which conducted under semi-static test, for a period of 96 h. The cumulative mortalities of 30,0%LS, 40.5%LS, 54.8%LS, 74.0%LS and 100%LS test groups were 0%, 0%, 0%, 0% and 100% respectively at the end of the test. The results of test substance to Rare Minnow (Gobiocypris rarus) described as 96 h median lethal concentration (LC50), the highest concentration causing 0% mortality at 96 h (LC0) and the lowest concentration causing 100% mortality at 96 h (LC100) were calculated based on the time-weighted means of measured concentrations.
The 96 h-LC50 to Rare Minnow (Gobiocypris rarus) was 1.40 mg/L and the 95% confidence limits are not reliable (based on the time-weighted means of measured concentrations).

Executive summary:

The purpose of the study is to evaluate the possible toxicity of the test substance to fish for a period of 96 h, with the effect of a short-term exposure to indicate the acute toxicity of the test substance.

The fish were exposed to the test substance for a test period of 96 hours. Mortalities and abnonnalities were recorded at 24 h, 48 h, 72 h and 96 h and the median lethal concentration, i.e. the calculated concentrations of test item which causes death in 50% of the test fish (24 h -LC50, 48 h - LC50, 72 h - LC50, 96 h - LC50) were detennined. At the same time, the highest test concentration without dead test organisms (LC0) and the lowest test concentration at which all test organisms were dead (LC100) within the period of the test, were determined.

The cumulative mortality of blank control was 0% at the end of the test, which met the validity criterion that the mortality should not exceed l 0%.

The cumulative mortalities of 30.0%LS, 40.5%LS, 54.8%LS, 74.0%LS and 100%LS test groups were 0%, 0%, 0%, 0% and 100% respectively at the end of the test.

The 96 h-LC50 to Rare Minnow (Gobiocypris rarus) was 1.40 mg/L and the 95% confidence limits are not reliable (based on the time-weighted means of measured concentrations).