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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:
key study
Study period:
December 2015 - January 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
not specified
Qualifier:
according to
Guideline:
other: Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures
Version / remarks:
OECD Guidance Document No 23, September 2000
Deviations:
not specified
Qualifier:
according to
Guideline:
other: Fish Acute Toxicity Test in "Testing Methods for New Chemical Substances"
Version / remarks:
March 31, 2011, No. 0331-7, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, March 29, 2011 No5. Manufacturing Industries Bureau, Ministry of Economy Trade and Industry, No. 110331009, Environmental Policy Bureau, Ministry of the Environment, Japan; latest revision, April 2, 2012, No.0402-1, Pharmaceutical and Food Safety Bureau, Ministry of Health Labour and Welfare, March 28, 2012, No 2. Manufacturing Industries Bureau, ministry of economy, trade and industry, no 1. Environmental Policy Bureau, Ministry of the Environment, Japan
Deviations:
not specified
GLP compliance:
yes
Specific details on test material used for the study:
Chemical name: (Z)-1-chloro-2,3,3,3-tetrafluoropropene
Other name: HCF0-1224yd(Z)
Molecular formula: C3HClF4
Molecular weight: 148.49
Purity of test item: >99% (GC area%)
Supplier: ASAHI GLASS CO., LTD.
Lot number: 151007
The test item was treated as 100% in purity.

Test sample was sorted in a dark storage place at room temperature.
Analytical monitoring:
yes
Details on sampling:
Frequency of measurement: At the start of exposure, before and after the renewal, and at the end of exposure.
Sample for measurement: Taken from the preparation container. The solution for analysis was taken out from the middle layer of each test vessel in each test level.
Volume of sample: Approximately 10 mL (all test levels)
Vehicle:
no
Details on test solutions:
Dilution water
Dechlorinated tap water, aerated sufficiently and temperature-controlled, was used. Some chemical characteristics of the dilution water measured regularly are listed in Appendix 1. The result of chemical characteristics of the dilution water met the standards that were provided with the standard operation procedure of this laboratory.

Test apparatus and equipment
Test vessel: 3L Glass tank (diameter: 16cm, depth: 16cm)
Cover on test vessel: A test vessel was made airtight by glass lid.
Water bath: Plastic tank. Warming/cooling unit; HCA250 (Sato craft)

After dilution water was added in sampling bag for gas analysis, gaseous test sample was enclosed in the bag. The bag was shaken about 2 hours. After that, the solution was settled for approximately 25-49 hours about 22°C to prepare the stock solution. The day that the test solution was prepared, test item concentration of stock solution was measured (Analytical method was shown in Appendix 2.). Required amount of test solution and dilution water were mixed in the preparation vessel and stirred to prepare the test solution. The test solution was added in the test vessel and shut without headspace by glass plate. Test solution for renewal was prepared every day.
Test organisms (species):
Oryzias latipes
Details on test organisms:
Species: Medaka (Oryzias latipes)
Reason for selection of species: Species recommended in the test guidelines
Supplier: CERI Kurume (in-laboratory production)
Size: Total length 2.5+-0.1 cm.
Bodyweight: 0.16+-0.04g
Allocation: Medaka was allocated at random to each test group.
Lighting condition: Room light, 16-hour light/8-hour dark
No feeding (feeding withdrawal 24 hours before the start of exposure)
Test type:
semi-static
Water media type:
other: Dechlorinated tap water
Total exposure duration:
96 h
Test temperature:
24+-1C
pH:
No adjustment
Dissolved oxygen:
No aeration. Dissolved oxygen concentration at least 60% of the air saturation value at the water temperature throughout exposure duration.
Nominal and measured concentrations:
Nominal concentration: 200, 100, 50, 25, 13 mg/L (geometric series with a factor of 2.0).
Measured concentration: 145, 69.8, 37.9, 18.2 and 9.69 mg/L
Details on test conditions:
Semi-static regime (renewal every 24hours), closed system, without headspace
Control: Dilution water without the test item
1 replicate/test level
7 fish/test level
Volume of test solution: Approx. 3.2 L/test level
Temperature: 24+-1C
Reference substance (positive control):
yes
Remarks:
Copper (II) sulfate pentahydrate (JIS special grade, Wako Pure Chemical Industries, Lot. No. CTP2097)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
101 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
The test concentrations in the test solution were generally maintained and the environmental conditions were within the suitable range, therefore it was concluded that this study complied with the applied test guidelines.
Results with reference substance (positive control):
Substance: Copper (II) sulfate pentahydrate (JIS special grade, Wako Pure Chemical Industries, Lot. No. CTP2097)
Test period: November 16 to November 20, 2015
96hr LCto: 0.41 mg/L. This value was within the stipulated range (mean +- 2S.D.)(0.53 +- 0.19 mg/L (n=57) to background data in this laboratory.
Reported statistics and error estimates:
Statistical procedure used for determination of LC50: Binomial test
LC50 estimated using computer program (running on Microsoft Excel) developed by laboratory

Cumulative mortality (%)

 Measured concentration (mg/L)

Cumulative mortality (%)

   3 hours 24 hours  48 hours  72 hours  96 hours 

 Control

0  0  0  0  0
 9.69  0  0  0  0  0
 18.2  0  0  0  0  0
 37.9  0  0  0  0  0
 69.8  0  0  0  0  0
 145  57  100  100  100  100
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of HCFO-1224yd(Z) to Medaka was determined in a 96-hour test according to OECD guideline 203. The LC50 (mortality) was determined to be 101 mg/l (Geometric mean measured concentration). There were no deviations from the guideline and the validation criteria were all met.
Executive summary:

The acute toxicity of HCFO-1224yd(Z) to Medaka was determined in a 96-hour test according to OECD guideline 203. The LC50 (mortality) was determined to be 101 mg/l (Geometric mean measured concentration). There were no deviations from the guideline and the validation criteria were all met.

Description of key information

The acute toxicity of HCFO-1224yd(Z) to Medaka was determined in a 96-hour test according to OECD guideline 203. The LC50 (mortality) was determined to be 101 mg/l. There were no deviations from the guideline and the validation criteria were all met.

Key value for chemical safety assessment

LC50 for freshwater fish:
101 mg/L

Additional information