trans-5-butyl-2-(3',3'',4'',5''-tetrafluoro-1,1':4',1''-terphenyl-4-yl)-1,3-dioxane

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 10, 2012 - Dec 04, 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Version / remarks:

1996

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Samples were taken (at least in duplicate) from each concentration during the Limit Test at 0, 24, 48, 72 and 96 h. On each occasion, one sample was analysed after pre-treatments (see below); the remaining samples were retained in case further analysis would be required.

Pre-treatment method ofthe sample
50.0 ml collected water samples were diluted to 100 mL with 80% acetonitrile solution (acetonitrile: water = 80:20 (v:v)) and filtered with a 0.22 μm millipore membrane( discarding the initial 1 0mL filtrates ), then the filtrates were analysed by UPLC.

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: test item directly added into dilution water, ultrasonicated for 20 min. For the limit test WAF solutions with a nominal concentrations of 100 and 150 mg/L were prepared. Aqueous test substance mixture was stirred for 24 h at 23-25°C.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish (Batch F20120315)
- Source: Guangzhou Hongfa Aquatic Animals Culture Company, China
- Length at study initiation: mean 2.38 cm
- Weight at study initiation: mean 0.25 g

ACCLIMATION
- Acclimation period: Feeding fry held for 28 days supplied with a continuous flow of aerated water before test. Fish to be used for test was held for 7 days under test conditions.
- Acclimation conditions (same as test or not): yes
- Type and amount of food during acclimation: crude protein >49.0%, crude fat >5.0%, crude fibre <3.0%, crude ash <12%, moisture <10.0%

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

122.2 mg/L CaCO3

Test temperature:

23.2 °C to 24.0 °C

pH:

7.55 - 7.67

Dissolved oxygen:

80-93 % of saturation

Nominal and measured concentrations:

Nominal concentration 100 mg/L WAF measured range: 0.116 - 0.125 mg/L
Nominal concentration 150 mg/L WAF measured range: 0.106 - 0.128 mg/L

Details on test conditions:

TEST SYSTEM
- Aeration: no
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.7 - 0.8 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated tap water

OTHER TEST CONDITIONS
- Photoperiod: 16 h light/8 h dark
- Light intensity: 1000 - 1500 lux

EFFECT PARAMETERS MEASURED:
mortality, inactivity, abnormal swimming pattern, other abnormal behaviour recorded at 24, 48, 72 and 96 h

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 1.0, 10.0, 100 mg/L

- Full range
- Test concentrations: 100.0, 150 mg/L (WAF)

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 150 mg/L

Nominal / measured:

nominal

Conc. based on:

other: accomodated fraction (WAF)

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.128 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mortality (fish)

Remarks on result:

other: value based on measured concentration

Results with reference substance (positive control):

24h-LC50: 269 mg/L (potassium dichromate)

Validity criteria fulfilled:

yes

Conclusions:

In this study no toxic effects were observed within 96 h. Therefore, the LC50 is determined to be >150 mg/L (WAF) and > 0.128 mg/L (measured concentration).

Executive summary:

Study design

The test item was tested in a GLP study according to OECD GL 203.A range-finding test and then a limit test were performed. Nominal concentrations of 1, 10 and 100 mg/L were used in the range-finding test, while nominal concentrations of 100 and 150 mg/L WAFs were used in the limit test. Water samples taken from the control and the test treatments in the limit test were analysed. The mean analyzed concentrations were 0.120 mg/L and 0.128 mg/L respectively. The analytical results showed that the concentration of the test item is consistent in the test medium throughout the 96-hour test period ( deviation within 20% ). Thus a static procedure was reasonable.

Results

In the range-finding test, 5 fishes per treatment and no replicates were used, while 10 fishes per treatment and 3 replicates in the limit test in the limit test. The test fishes were exposed for 96 hours to the test solution. During the whole test period, the pH values of the control media and test media were between 7.55 and 7.67, and the Dissolved Oxygen (DO) values varied from 80% to 93% of the air saturation at the test temperature, and the total hardness was in the range of 119 to 125 mg (CaCO3)/L.

During the test, the temperature ofthe test media were maintained in the range of 23.2°C to 24.0°C, at\d all fishes in the control group were n01mal. With the same conditions, K₂Cr₂O₇was used as the positive control substance, and the resulting 24 h-LC50 was 284 mg/L. So the study met the acceptability criteria prescribed by the protocol (pH: 6.0~8.5; dissolved oxygen concentration: > 60% of the air saturation value; total hardness: 10~250 mg (CaCO₃)/L; temperature: (23 ±2) °C; 24 h-LC50 of K₂Cr₂O₇in the range of 200 to 400 mg/L). Therefore the test was considered valid.

During the whole test period, all fish in the control groups and treated groups were alive and appeared normal. The results showed that under valid static test conditions, the 96 h-LC50 of the test item to zebra fish is greater than the nominal concentration of 150 mg/L WAFs (measured concentration 0.128 mg/L), which the maximum concentration causing no m01iality of the test item to zebra fish is the nominal concentration of 150 mg/L WAFs (measured concentration 0.128 mg/L).

Conclusion

In this study no toxic effects were observed within 96 h. Therefore, the LC50 is determined to be >150 mg/L (WAF) and > 0.128 mg/L (measured concentration).

Description of key information

The informtion for this endpoint study record was obtained from an experimental study. The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 203. In this study no toxic effects were observed within 96 h. Therefore, the LC50 is determined to be >150 mg/L (WAF) and > 0.128 mg/L (measured concentration).