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EC number: 428-650-4 | CAS number: 153719-23-4
Table:Effects of the test substance onCyprinodon variegatus
Mean Measured Concentration (mg/L)
Mean Embryo Hatching Success (%)*
Mean Live, Normal Larvae at Hatch (%)
Larvae (28 days post-hatch)
Mean Larval Survival (%)
Mean Total Length (mm)**
Mean Dry Weight (g)**
Endpoint Summary (µg/L)
* Values presented represent hatching success at the completion of hatch (test day 5).
** Standard deviation for each replicate is presented in parentheses.
*** Significantly reduced compared to the control, based on Dunnett’s Multiple Comparison Test.
**** The conditions in the protocol for determining an ECx were not satisfied (i.e., the test concentrations will bracket the ECx and the ECx comes from linear interpolation rather than extrapolation) therefore, the NOEC approach was used.
The chronic toxicity of the substance to marine water fish was determined in a GLP-compliant study according to OECD 210 (fish early-life stage toxicity test). In this study, groups of sheepshead minnow (Cyprinodon variegatus) embryos and larvae (80 larvae per treatment) were exposed to nominal concentrations of 0 (control), 0.10, 0.26, 0.64, 1.6, 4.0 and 10 mg/L for 33 days (5 days pre-hatch; 28-days post hatch) under flow-through conditions. Analytical confirmation of nominal test concentrations showed that all test concentrations remained well within ±20% of nominal concentrations throughout the test (<LOQ, 0.090, 0.23, 0.74, 1.7, 4.1 and 9.9 mg/L mean measured). Following 28 days post-hatch exposure, data for embryo hatching success, the percent of live, normal larvae at hatch, larval survival, total length, wet weight and dry weight were evaluated. Based on mean measured concentrations and mean total length (determined to be the most sensitive endpoint), the 28-day NOEC was determined to be 1.7 mg/L and 28-d LOEC value was determined to be 4.1 mg/L for sheepshead minnow exposed to the substance.
The long-term toxicity of the test substance to fish was examined in an early life-stage toxicity study according to the FIFRA 72-4 guideline and in compliance with GLP criteria. In this study groups of Rainbow Trout (Oncorhynchus mykiss) were exposed to nominal test concentrations of 0 (control), 1.3, 2.5, 5.0, 10 and 20 mg a.i./L for 88 days (which included a 28-day hatching period and a 60-day post-hatch
period) under flow-through conditions. Nominal test concentrations were analytically verified and determined to remain well within ± 20% of nominal. Embryo survival (hatching success), time to hatch, time to swim-up of the larvae, and the post-hatch growth and survivalwere measured for the rainbow trout in each treatment and the control group. Observations were made during the embryo incubation and post-hatch periods to assess the effects of the test substance on these parameters. Fish lengths were measured at 31 days post-hatch and at test termination. The wet weight and dry weight of each surviving fish were measured at test termination. There were no apparent differences among the experimental groups in the time required for hatching. Hatching success in the negative control group averaged 77%. Hatching percentages in the 1.3, 2.5, 5.1, 10 and 20 mg a.i./L treatment groups were 73, 74, 75, 76 and 73%, respectively. Furthermore, there were no apparent treatment-related effects on time to hatch, time to reach the swim-up stage of development, larvae survival, fiy survival and growth of the organisms in the control group or any of the test substance treatment groups throughout the study. Based on these findings, the 88-d NOEC was determined to be 20 mg a.i./L.
All available data were assessed and the studies representing the worst-case effects were included as key or weight-of-evidence studies. Other studies are included as supporting information. The key studies are considered to be worst-case and were selected for the CSA.
The 28-day NOEC was determined to be 1.7 mg/L and 28-d LOEC value was determined to be 4.1 mg/L for the marine species sheepshead minnow exposed to the substance. The 88-day NOEC was determined to be 20 mg/L for the freshwater species rainbow trout exposed to the substance.
Table: Overview of available data on the long-term toxicity to fish
Guideline / GLP
(incl. 28-day hatching period)
20 mg a.i./L
Flow-through regime. Measured concentrations remained within 20% of nominal.
OECD 210/ GLP
28-d NOEC28-d LOEC
1.7 mg a.i./L
4.1 mg a.i./L
The validity criteria were met.
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