3-sec-[C15-18-(branched and linear)-alk-2-enyl]pyrrolidine-2,5-dione

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 29, 2019 to , June 20, 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Test substance is a UVCB

Analytical monitoring:

yes

Details on sampling:

The actual concentrations of test substance in the 100 mg/L WSF test group were analyzed at 0h, 72 h (new solution) and 24 h, 96 h (old solution). The blank control was analyzed at 0 h (new solution) and 24 h ( old solution).

Vehicle:

no

Details on test solutions:

0.50 g test substance was weighed directly into a 5 L - vessel and dissolved with test water to 5000 mL to obtain the nominal concentration of 100 mg/L test suspension. The test suspension was stirred with a magnetic stirrer for about 48 h (the depth of vortex was maintained at one third of the test solution height). Then the mixture was filtered through 0.45 μm polyether sulfone (PES) filter membranes, and the nominal loading rate of 100 mg/L WSF test solution was obtained and used in the test directly.

Note: The filter membranes were pre-saturated in a small amount of saturated solution for about 30 min
before they were used for filtering the test substance suspension.

Test organisms (species):

other: Rare Minnow (Gobiocypris rarus)

Details on test organisms:

Rare Minnow (Gobiocypris rarus) with the batch number was FGr20181024-1031. Before the start of the test, Rare Minnow (Gobiocypris rarus) were acclimated for 99 days under the same conditions of the test (water quality: dechlorinated tap water, temperature: 23 °C ± 2 °C, photoperiod: 14 h light / 10h darkness). The dissolved oxygen concentration during acclimation was kept above 80% of the air saturation value. The fish were fed one time on each workday until 24 hours before the test was started. The mortality was 0% during the 7 days prior to the start of the test, which met the requirement of mortalities being Jess than 5% of the population.

The sensitivity test of reference substance K2Cr207 (performed on February 25, 2019) showed that the 96 h-LC50 of K2Cr207 to Rare Minnow (Gobiocypris rarus) was 193 mg/L and the 95% confidence limits ranged from 152 mg/L to 244 mg/L

Total number of test fish 14 fish (The sex of fish was not determined.)

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

135 mg/L, CaC03

Test temperature:

23.4 °C to 23.8 °C

pH:

7.72 to 8.32

Dissolved oxygen:

67% to 103%.

Nominal and measured concentrations:

100 mg/L WSF test

Details on test conditions:

Conditions of exposure
Type of test:
Semi-static limit test, with renewals at 24 h intervals
Exposure duration:
96 h
Test concentration:
A nominal loading rate of 100 mg/L WSF test group was selected.
Control:
A blank control (test water without test substance) was tested in parallel.
Replicate:
No replicates
Number of fish:
7 fish I group, 14 fish in total
Volume of test solution:
4.8 L/ test vessel
Loading of test fish:
7 fish/ test vessel; 0.230 g fish/L

Reference substance (positive control):

yes

Key result

Duration:

96 h

Dose descriptor:

LL50

Remarks:

based on WSF loading rate

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

The test substance is a UVCB hence toxicity cannot be attributed to a single component but to the test substance as a whole, the test results are reported based on nominal loading rates only.

Sublethal observations / clinical signs:

End Points	Effect value
LL50	> 100 mg/L (Based on the nominal loading rate WSF)
LL100	> 100 mg/L (Based on the nominal loading rate WSF)
LL0	= 100 mg/L (Based on the nominal loading rate WSF)

Validity criteria fulfilled:

yes

Conclusions:

The toxicity effects of test substance on Rare Minnow (Gobiocypris rarus) described as the 96 h median lethal loading rate, LL50 is >100 mg/L (Based on the nominal loading rate WSF).

Executive summary:

The toxicity of the test substance to Rare Minnow (Gobiocypris rarus) was determined following the OECD guideline 203 and other applicable guidelines. The study was conducted in accordance to GLP. The test was conducted as a 100 mg/L WSF (water soluble fraction) due to the test substance being a UVCB with low water solubility, and as a limit test under semi-static conditions (24 h renewals), based on the results of the range-finding test. No replicates were used in the study: a total of 14 fish were used: 7 fish/group (two groups -- 100 mg/L WSF and blank control). Test solutions of the blank control and the 100 mg/L WSF were observed to be clear and colorless. At the end of the test, the cumulative mortality of the 100 mg/L WSF test group was 0%. The 96 h median lethal loading rate (LL50) of the test substance to Rare Minnow (Gobiocypris rarus) was determined to be > 100 mg/L (nominal loading rate WSF), the lowest loading rate causing 100% mortality (LL100) was determined to be > 100 mg/L (nominal loading rate WSF), and the highest loading rate causing 0% mortality (LL0) was determined to 100 mg/L (nominal loading rate WSF).

Description of key information

Under the conditions of this study, exposure of the test material to the freshwater fish Rare Minnow (Gobiocypris rarus) has been investigated and gave a 96-hour LL50 value of greater than 100 mg/L loading rate WSF.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

The toxicity of the test substance to Rare Minnow (Gobiocypris rarus) was determined following the OECD guideline 203 and other applicable guidelines. The study was conducted in accordance to GLP. The test was conducted as a 100 mg/L WSF (water soluble fraction) due to the test substance being a UVCB with low water solubility, and as a limit test under semi-static conditions (24 h renewals), based on the results of the range-finding test. No replicates were used in the study: a total of 14 fish were used: 7 fish/group (two groups -- 100 mg/L WSF and blank control). Test solutions of the blank control and the 100 mg/L WSF were observed to be clear and colourless. At the end of the test, the cumulative mortality of the 100 mg/L WSF test group was 0%. The 96 h median lethal loading rate (LL50) of the test substance to Rare Minnow (Gobiocypris rarus) was determined to be > 100 mg/L (nominal loading rate WSF).