Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12-2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: TCCA(Toxic Chemical Control Act)-Test Guidelines described in Annex 5 of TCCA-Good Laboratory Practice Standards and Test Guidelines” Notification No. 2012-23, National Institute of Environmental Research, Korea (Aug. 22, 2012)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Test substance name: MI RAMER M1086
Appearance : Clear liquid
Manufacturing date: 2012-03-29
Supplier:Miwon Specialty Chemical Co., Ltd.
Receipt day: 2012-05-23
Deli very amount: 399.223 g(Gross)
Cas No.:117646-83-0
Lot No.:120329JY1
Purit y: 95.55 %
Expiration date: 2013-03-28 (Manufactured after 1 year)
Storage condition: Room temperature [(15 ~ 25)°C

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
yes
Details on test solutions:
As a result of the preliminary test for the solubility of the dilution water, the test substance was a poor water-soluble substance. Also, the test substance was unstable in dilution water during 24 hours. Therefore, this study was conducted using the organic solvent according to the OECD Guidance Document No. 231), and the test substance was stable in dilution water for 24 hours. The test solution was prepared using the organic solvent, triethylene glycol.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Source
Nine through seventeen day old daphnids were obtained from the National Institute of Agricultural Science & Tech. (249, Seodun-dong, Gwonseon-gu, Suwon-si, Gyeonggi-do, Korea) on Oct. 22, 2009. Twenty to sixty daphnids were maintained in a glass beaker with 800–1,600 mL of dilution water.

Maintenance of daphnids
Young daphnids of less than 24-hour old were obtained from the mature daphnids of more than 14-day old and giving birth to over three generations and were transferred to new culture beakers and bred for 28 days. The culture beaker was maintained at 20±1°C in a water bath under on a cycles of 16 hours of continuous artificial light and 8 hours of continuous darkness. The daphinds were fed daily with a suspension of Chlorella sp. (0.1–0.2 mgC per daphnid).
During the culture period, Daphnia holding cultures were observed for general condition (behavior, antennae movement and appearance), neonate production and ephippia once daily.
Young daphnids of less than 24-hour old obtained from the mature daphnids of more than 14- day old and giving birth to over three generations were used for this study.

Identification
Test system was not individually identified and labels indicating the study number and test concentration was placed on replicate test dishes containing daphnids.

Study design

Test type:
semi-static
Water media type:
freshwater
Total exposure duration:
48 h

Test conditions

Test temperature:
20±1°C
pH:
6–9
Dissolved oxygen:
not less than 3 mg/L
Reference substance (positive control):
yes

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
0.61 mg/L
Nominal / measured:
meas. (geom. mean)
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
0.47 mg/L
Nominal / measured:
meas. (geom. mean)
Details on results:
During an exposure period, the EC50 at 24 hours after exposure was determined to be 0.61 mg/L (measured concentration, 95% confidence limits: 0.56–0.66 mg/L), the EC50 at 48 hours after exposure was determined to be 0.47 mg/L (measured concentration, 95% confidence limits: 0.41–0.53 mg/L).
The highest concentration causing no immobility was determined to be 0.2476 mg/L (measured concentration), the lowest concentration producing 100% immobility was determined to be >0.7885 and 0.7885 mg/L (measured concentration) at 24 and 48 hours after exposure, respectively.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
In conclusion, the EC50 obtained under the test conditions with the test substance, MIRAMER M1086, was determined to be 0.61 mg/L (measured concentration, 95% confidence limits: 0.56–0.66 mg/L) at 24 hours and 0.47 mg/L (measured concentration, 95% confidence limits: 0.41–0.53 mg/L) at 48 hours, respectively. At the end of exposure, the highest concentration causing no immobility was determined to be 0.2476 mg/L (measured concentration), the lowest concentration producing 100% immobility was determined to be 0.7885 mg/L (measured concentration), respectively.
Executive summary:

This study was designed to assess the acute toxicity of the test substance, MIRAMER M1086, on the immobilisation of Daphnia magna during an exposure period of 48 hours under static conditions and to determine the median effective concentration (EC50) of immobilisation. The desired nominal concentrations were selected at dose level of 10, 17, 31, 56 and 100 mg/L.

The concentration analysis of the test substance in the test solutions was conducted in the 100, 56, 31, 17 and 10 mg/L treatment groups. As a result, the accuracies and precisions (CV) were 107.98, 99.45, 92.52, 86.74, 97.04% and 2.80, 8.21, 6.97, 4.90, 6.44% at the start of exposure (0 hour), 89.56, 110.44, 102.33, 91.49, 108.17% and 2.02, 7.87, 7.47, 5.47, 3.53% at 24 hours after exposure (before renewal of test solution), 85.68, 85.95, 98.44, 103.43, 109.67% and 9.66, 2.93, 2.94, 3.82, 5.43% at 24 hours after exposure (after renewal of test solution), 51.37, 51.00, 48.09, 63.18, 67.57% and 6.90, 1.18, 5.30, 6.16, 8.47% at 48 hours after exposure, respectively.

No test substance was detected in the test solutions of the control group (including the solvent control group).

The concentration in the test solution in each treatment group was within ±20% of nominal values for solubility at the start of exposure and 24 hours after exposure (before and after renewal of test solution). But, the concentration in the test solution in each treatment group exceeded ±20% of 24 hours after exposure (after renewal of test solution) at 48 hours after exposure. Therefore, all test results were calculated based on the geometric means of the measured values during the exposure period.

Based on the results of this study, the EC50 obtained under the test conditions with the test substance, MIRAMER M1086, was determined to be 0.61 mg/L (measured concentration, 95% confidence limits: 0.56–0.66 mg/L) at 24 hours and 0.47 mg/L (measured concentration, 95% confidence limits: 0.41–0.53 mg/L) at 48 hours, respectively. At the end of exposure, the highest concentration causing no immobility was determined to be 0.2476 mg/L (measured concentration), the lowest concentration producing 100% immobility was determined to be 0.7885 mg/L (measured concentration), respectively.