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Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-Propenoic acid, 2-methyl-, 1,3-dioxan-5-yl ester
EC Number:
603-690-7
Cas Number:
132977-93-6
Molecular formula:
C8H12O4
IUPAC Name:
2-Propenoic acid, 2-methyl-, 1,3-dioxan-5-yl ester
Constituent 2
Chemical structure
Reference substance name:
2-Propenoic acid, 2-methyl-, 1,3-dioxolan-4-ylmethyl
EC Number:
600-641-1
Cas Number:
10525-59-4
Molecular formula:
C8H12O4
IUPAC Name:
2-Propenoic acid, 2-methyl-, 1,3-dioxolan-4-ylmethyl
Test material form:
liquid

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
other: Gobiocypris rarus
Details on test organisms:
(1) Species Rare Minnow ( Gobiocypris rarus)

The test species Rare Minnow is recommended by "The Guidelines for the Testing of
Chemicals, 203 Fish Acute toxicity test" (Chemical Registration Center ofMEP, Second
Edition).

Reproduction by the test laboratory.

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Remarks on exposure duration:
Renewal of water after 48 hrs
Post exposure observation period:
no

Test conditions

Hardness:
135 mg/L (expressed as CACO3)
Test temperature:
23.4°C - 23.8°C
pH:
8.19 (7.36 - 8.38)
Dissolved oxygen:
96% (62 - 99%)
Salinity:
n.d.
Conductivity:
n.d.
Nominal and measured concentrations:
Nominal 25.0; 35.4; 50.0; 70.7; 100.0 mg/L
measured 21.4; 29.2; 41.6; 58.8 mg/L after 96hrs; 88,8 mg/L after 72hrs
Reference substance (positive control):
yes
Remarks:
LC50 for the reference substance (K2Cr2O7) of 206 mg/L was achieved in a seperate study.

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
59.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
35.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities:
No abnormal responses of test fish were observed in the blank control and 25.0 mg/L, 35.4
mg/L test groups. The abnonnal responses of "immobilized at the bottom" and "activity at the surface" were observed in test fish of 50.0 mg/L test group; "reduction of activity", "lying at the bottom" and "activity at the surface" were observed in test fish of 70. 7 mg/L test group; "reduction of activity" was observed in test fish of 100 mg/L test group, and all test fish were died after 72 h of the start of test.

- Observations on body length and weight:
The average and standard deviation of body weight and length of the test fish are shown in Table 5. The average and standard deviation of body weight and total length of 7 test fish were 0.263 g ± 0.060 g and 30.60 mm ± 2.49 mm, respectively. So loading rate of fish in the test was 0.368 g fish / L, which met the requirement of ::::; 1.0 g fish / L and total length was within the range of 30 mm ± 10 mm.


- Other biological observations:

- Mortality of control:
The mortality of blank control was 0% at the end of the test

- Other adverse effects control:
No other adverse effects have been observed in the control.

- Abnormal responses:
No abnormal responses in the control are reported.

- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values:
No observations (e.g. precipitation) that might cause a difference between measured and nominal values are reported.

- Effect concentrations exceeding solubility of substance in test medium:
No.
Results with reference substance (positive control):
Sensitivity test of the reference substance K2Cr2O7 to Rare Minnow ( Gobiocypris rarus):
The test results showed that (the test was conducted on November 1, 2018), the 96 h -
LC50 of the reference substance (K2Cr2O7) to Rare Minnow (Gobiocypris rarus) was
206 mg/L and the 95% confidence limits ranged from 179 mg/L to 236 mg/L.
Reported statistics and error estimates:
Cumulative mortalities of each test group at 24 h, 48 h, 72 h and 96 h after the start of the test
were calculated. The LC50 values of test substance to Rare Minnow ( Gobiocypris rarus) at
24 h, 48 h, 72 h and 96 h were calculated by Binomial Distribution (CT-TOX Multi-Method
Program, IBM PC Version 1.1), Trimmed Speannan Karber Method (US EPA data stat) and
EPA PROBIT ANALYSIS PROGR AM Version 1.5.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
In a valid acute toxicity study over 96 hours under semi static conditions (renewal of test medium aftert 48 h) the test species rare minnow (Gobiocypris rarus) was exposed to the test item Glycerol fonnal methacrylate.
The following endpoints were detrmined:
96 h-LC50 59.5 mg/L, 95% confident limit was 49.6 mg/L- 71.3 mg/L
96 h-LC100 100 mg/L
96 h-LC0 35.4 mg/L
Executive summary:

In a valid acute toxicity study over 96 hours under semi static conditions (renewal of test medium aftert 48 h) the test species rare minnow (Gobiocypris rarus) was exposed to the test item Glycerol formal methacrylate.

The measured concentrations of main constituent of test substance in blank control at O h and

48 h (old solution) were both lower than the LOD 0.149 mg/L.

In nominal concentrations of 25.0 mg/L, 35.4 mg/L, 50.0 mg/L, 70.7 mg/L and 100 mg/L test

substance groups, the measured concentrations of main constituent of test substance in fresh

test solutions (at O h and 48 h) ranged from 22.7 mg/L - 92.0 mg/L, and in the old test

solutions (at 48 h and 96 h) ranged fonn 20.3 mg/L- 88.8 mg/L. The measured concentrations

of main constituent of test substance was equal to 81 % - 94% of the nominal concentrations of

main constituent, therefore the test results were expressed with nominal concentration.

The acute toxicity of test substance to Rare Minnow ( Gobiocypris rarus) was performed as

definitive test under semi-static conditions (48 h intervals). At the end of the test, the

cumulative mortalities in the nominal concentrations of 25.0 mg/L, 35.4 mg/L, 50.0 mg/L,

70.7 mg/L and 100 mg/L test substance groups were 0%, 0%, 14%, 86% and 100%,

respectively. Hence, the results described as the 96 h median lethal concentration (LC50), the

lowest concentration causing 100% mortality (LC100 ), and the highest concentration causing

0% mortality (LC0) are given as below:

End points Effect value*

96 h-LC50 59.5 mg/L, 95% confident limit was 49.6 mg/L- 71.3 mg/L

96 h-LC100 100 mg/L

96 h-LC0 35.4 mg/L

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