3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene

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:

From August 2017 to January 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

- Appearance: Clear colourless liquid
- Test item storage: At room temperature protected from light
- Purity/Composition correction factor: No correction factor required

Analytical monitoring:

yes

Details on sampling:

Samples were taken from test group of fresh media at 0 and 72 hours, and of old media at 24 and 96 hours.

Vehicle:

no

Details on test solutions:

Test item was added directly into test water to prepare the test solution. The weight of test item was calculated according to the volume of bottles; 1.13231-1.15963 g the test item was weighted and moved into a glass bottle (with a stopper) respectively. Test water of 11.3
-11.6 L was filled into the bottles respectively, and then be magnetic stirred (350 - 420 rpm) for about 24 hours to get the test solution. Following the stirring period, the test solution was settled for about 24 hours, and then the upper 1/3 solution was taken to use for test by siphon device. During this process, the closed system was used to prevent the volatilization of the test item.

Test organisms (species):

other: Gobiocypris rarus

Details on test organisms:

TEST ORGANISM
- Common name: Gobiocypris rarus
- Source: in-house culture
- Length at study initiation: 2.3 to 2.9 cm
- Weight at study initiation: 0.2346 - 0.3012

ACCLIMATION
- Acclimation period: more than 14 days:
- Temperature: 21-25°C (constant within a range of 2°C)
- pH: 6.0-8.5
- Dissolved oxygen concentration: > 80% of air saturation value (ASV)
- Photoperiod: light/dark = 12 hours/12 hours;
- Feeding: brine shrimp twice on workday and once on weekend which was discontinued approximately 24 hours prior to the start of the definitive test
- Health during acclimation (any mortality observed): There were no any sign of disease or mortalities maintained in-house since June 13, 2016 and the fish were held in water of the quality to be used in the test during the acclimation period and under the following conditions:


FEEDING DURING TEST : none

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

22.07 - 23.36°C.

pH:

8.10 - 8.34

Dissolved oxygen:

86.9-100.5% of the air saturation value (ASV)

Nominal and measured concentrations:

Nominal concentrations (limit test): 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Aeration: continuous over 24h
- Renewal rate of test solution: every 24h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: <1.0 g fish /L water

TEST MEDIUM / WATER PARAMETERS :
Source/preparation of dilution water: The water used for the aquatic test was water treated with aquapro pure water system


OTHER TEST CONDITIONS
- Photoperiod: light/dark = 12 hours/12 hours

EFFECT PARAMETERS MEASURED : The fish in the test and control groups were observed daily. Toxic signs and mortality were recorded at 2, 4, 24, 48, 72 and 96 hours after exposure.

OTHER PARAMETERS MEASURED: Dissolved oxygen concentrations and pH-values of fresh and old media were measured daily during the 96-hour exposure period in both control and test solution. The environmental temperature was monitored by automatic temperature monitoring system and recorded at 1 hour interval.

LIMIT TEST CONCENTRATIONS
- Range finding study : not performed, only a limit test was performed
- Test concentrations: 100 mg/L (nominal)
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Key result

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.62 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 0.62 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

ANALYTICAL RESULTS:
For the test solutions of nominal concentrations of 100 mg/L, the mean determined concentration was 0.66 mg/L in the fresh solutions and 0._59 mg/L in the old solutions. The mean measured concentration was 0.62 mg/L.

TOXIC SIGNS and MORTALITY:
During the 96-hour exposure period, the fish showed no poisoning signs or deaths in control vessels and 100 mg/L vessels

Sublethal observations / clinical signs:

ANALYTICAL RESULTS:

For the test solutions of nominal concentrations of 100 mg/L, the mean determined concentration was 0.66 mg/L in the fresh solutions and 0.59 mg/L in the old solutions. The mean measured concentration was 0.62 mg/L. Results are shown in the table below

Nominal concentration (mg/L)	Replicate	Measured Concentration of sample (mg/L)				Mean in fresh media (mg/L)	Mean in old media (mg/L)	Overall conc. (mg/L)
		2016-08-29		2016-09-01
		0h-Fresh	24h-old	72h-Fresh	96h-old
Control	1	<LOD	0.100*	<LOD	<LOD	-	-	-
100	1	0.67	0.57	0.75	0.55
	2	0.63	0.61	0.73	0.62	0.66	0.59	0.62
	3	0.62	0.54	0.57	0.63
	Mean	0.64	0.57	0.68	0.60

LOD :0.1 mg/L.

* the sample of control was suspected contaminated when pretreated because signal wasn't detected in the 0h sample.

TOXIC SIGNS and MORTALITY:

During  the 96-hour  exposure  period,  the  fish  showed  no  poisoning  signs or deaths in control vessels and 100 mg/L vessels.

Acceptability of the Test

1.No mortality was observed in the control during the test.

2. The dissolved oxygen concentrations in test solutions were between 86.9%- 100.5% ASV,which was greater than 60.0%of the air saturation value, throughout the test.

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the test, according to the lack of toxicological signs and death, the 96h-LC50 and the 96h-NOEC for Gobiocypris rarus exposed to the test item was determined to be > 0.62 mg/L and >= 0.62 mg/L based on measured concentrations of the limit test concentration (loading rate of 100 mg/L), respectively.

Executive summary:

The acute toxicity of the test item to the freshwater fish Gobiocypris rarus was investigated in a GLP-compliant study performed in accordance with OECD Guidelines No. 203. Under the conditions of the test, according to the lack of toxicological signs and death, the 96h-LC50 and the 96h-NOEC for Gobiocypris rarus exposed to the test item was determined to be > 0.62 mg/L and = 0.62 mg/L based on measured concentrations of the limit test concentration (loading rate of 100 mg/L), respectively.

It could be concluded that no toxicity was observed at the limit of solubility of the test item in the test medium.

Description of key information

The acute toxicity of the test item to the freshwater fish Gobiocypris rarus was investigated in a GLP-compliant study performed in accordance with OECD Guidelines No. 203. Under the conditions of the test, according to the lack of toxicological signs and death, the 96h-LC50 and the 96h-NOEC for Gobiocypris rarus exposed to the test item was determined to be > 0.62 mg/L and = 0.62 mg/L based on measured concentrations of the limit test concentration (loading rate of 100 mg/L), respectively.

It could be concluded that no toxicity was observed at the limit of solubility of the test item in the test medium.

Additional information

The toxicity of the test item to freshwater fish was investigated in one GLP-compliant study performed in accordance with standard methods, without deviations. The study is considered as reliable (Klimisch 1) and is selected as a key study for the endpoint.