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Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
December 17th, 1993 - March 3rd, 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: Plant drain water testing method, acute testing on fish (JIS K 0102-1986, 71)
Deviations:
not specified
GLP compliance:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 9221301
- Expiration date of the lot/batch: not specified

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in a dark and cool place
- Stability under test conditions: verified before the initiation of exposure
Analytical monitoring:
not specified
Details on sampling:
no data
Vehicle:
no
Details on test solutions:
The test substance was dissolved in deionized water and the mother solution was adjusted to a concentration of 2000 mg/L
Test organisms (species):
Oryzias latipes
Details on test organisms:
TEST ORGANISM
- Source: Nakashima fish nusery
- Length at study initiation: average 0.22g
- Weight at study initiation: average 2.9 cm
- Breeding conditions: At the time when the fish were received, a visual inspection was carried out and abnormal specimen were eliminated. They were placed inside a medicated water tank, and then raised for 3 days under running water.

ACCLIMATION
- Acclimation conditions: After breeding, the fish were transferred to the acclimation tank and immersed in medicated water. Then acclimation was carried out. During that time abnormal specimen were eliminated, and the rest were raised for 12 days under running at a water temperature of 25+/-2°C. After sorting out the fish and immersing them in medicated water once more, they were raised for 39 days under running water.
- Type and amount of food during acclimation: not specified
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
no
Test temperature:
25±2°C
pH:
6.6 to 7.6 at the initiation of exposure
7.5 to 7.7 at the termination of exposure
Dissolved oxygen:
7.9 to 8.0 mg/L at the initiation of exposure
5.8 to 7.2 mg/L at the termination of exposure
Nominal and measured concentrations:
Test concentrations: 8.78, 13.2, 19.8, 29.6, 44.4, 66.7, 100 mg N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide/L
Details on test conditions:
TEST SYSTEM
- Test vessel: cylindrical glass water tank
- Material, size, headspace, fill volume: 4 l
- Aeration: not specified
- Renewal rate of test solution (frequency/flow rate): water changed every 24 hours
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): not specified
- No. of vessels per control (replicates): not specified
- Biomass loading rate: not specified

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: underground water raised on the grounds of Kurumei Research Center
- Intervals of water quality measurement: periodical analysis (once every 6 months) of total hardness, evaporation residue, chemical oxygen demand, free chlorine, ammonia nitrogen as well as of noxious substances such as organic phosphorus, cyanide ion and heavy metals

OTHER TEST CONDITIONS
- Photoperiod: not specified
Reference substance (positive control):
not specified
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
22.6 mg/L
Nominal / measured:
not specified
Conc. based on:
other: N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide
Basis for effect:
mortality (fish)
Remarks on result:
other: according to Doudoroff's method
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
46.5 mg/L
Nominal / measured:
not specified
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: extrapolated from the composition of the test material
Details on results:
- Behavioural abnormalities: not specified
- Observations on body length and weight: not specified
- Mortality of control: no
- Other adverse effects control: not specified
- Abnormal responses: not specified
Validity criteria fulfilled:
not specified
Conclusions:
A 48-hour semi-static acute fish toxicity test was performed with Oryzias latipes according to a Japanese standard (JIS K 0102-1986, 71) and to GLP. A 48h-LC50 of 22.6 mg/L was determined for N-[2-(2-oxo-1-imidazolidinyl)ethyl] methacrylamide, and a 48h-LC50 of 46.5 mg/L was determined for the reaction mass of N-[2-(2-oxo-1-imidazolidinyl)ethyl] methacrylamide and methacrylic acid.
Executive summary:

A 48-hour semi-static acute fish toxicity test was performed with Oryzias latipes according to a Japanese standard (JIS K 0102-1986, 71) and to GLP. A 48h-LC50 of 22.6 mg/L was determined for N-[2-(2-oxo-1-imidazolidinyl)ethyl] methacrylamide, and a 48h-LC50 of 46.5 mg/L was determined for the reaction mass of N-[2-(2-oxo-1-imidazolidinyl)ethyl] methacrylamide and methacrylic acid.

Description of key information

Study 1. A 48-hour semi-static acute fish toxicity study was performed with Oryzias latipes according to a Japanese standard (JIS K 0102-1986, 71) and to GLP. A 48h-LC50 of 22.6 mg/L was determined for N-[2-(2-oxo-1-imidazolidinyl)ethyl] methacrylamide, and a 48h-LC50 of 46.5 mg/L was determined for the reaction mass of N-[2-(2-oxo-1-imidazolidinyl)ethyl] methacrylamide and methacrylic acid.

 

Study 2. A 32-day flow-through chronic fish toxicity study was performed with Pimephales promelas according to OECD Test Guideline and to GLP. During the range-finding test, fishes were exposed to the reaction mass of N-[2-(2-oxo-1-imidazolidinyl)ethyl] methacrylamide and methacrylic acid at the following concentrations: 0.14, 1.39, 13.9 and 139.1 mg/L. After 4 days of exposure, no significant mortality was observed at any of the test concentration. After 8 days of exposure, no significant mortality or clinical effects were observed in the control and the three lowest concentrations during the exposure; in the highest concentration (100 mg/L), only 25% of the introduced embryos survived the exposure.

 

The acute fish toxicity data from study 1, although not standard (test duration only half as long as the standard duration), can be used in a weight-of-evidence approach to assess the acute toxicity to fish of the reaction mass of N-[2-(2-oxo-1-imidazolidinyl)ethyl] methacrylamide and methacrylic acid. The (range-finding) fish toxicity data from study 2 suggest a 96h-LC50 above 100 mg/L and a 192h-LC50 between 10 and 100 mg/L, with Pimephales promelas. The observed trend is consistent with the fish toxicity data from study 1 which reports a 48h-EC50 of 46.5 mg/L with Oryzias latipes; although no toxicity data is reported for a 96h exposure period, the 48h toxicity value can be used as a default value for the hazard assessment, and PNEC derivation, to avoid any additional (and very likely unnecessary) testing on fishes.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
46.5 mg/L

Additional information

The 48h-EC50 of 46.5 mg/L obtained with Oryzias latipes is used as a default value for the hazard assessment, and PNEC derivation.

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