1,1,2,2,3,3,4-heptafluorocyclopentane

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

From 2008-12-25 to 2008-12-30

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

GLP compliance:

no

Remarks:

Non GLP, but in accordance with the test plan and the SOP and the final report fully and accurately reflects the result.

Specific details on test material used for the study:

Purity: >97%

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 100 mg/L
- Sampling time: 0, 24 h

Vehicle:

no

Details on test solutions:

- Preparing the stock solution:
0.5g test item was dissolved in some distilled water. The mixed solution was diluted to 500mL with distilled water, with the concentration of 1g/L. The stock solution was transparent with little liquid drop at the bottom. The stock solution was prepared immediately before use.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Source: Pearl River Fishery Research Institute of Chinese Academic of Fishery Science.
- Length and weight: 1.8 cm to 2.7 cm at length and 0.087 g to 0.176 g at weight per fish.

ACCLIMATION
- Acclimation period: 7 days
- Type and amount of food during acclimation: feedstuff supplied by Guangzhou Weihu Aquatic Biotechnology Co., Ltd.
- Feeding frequency during acclimation: fed daily

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

100.1 mg/L (CaCO3)

Test temperature:

21.5 - 21.6 °C

pH:

7.3 - 7.6

Dissolved oxygen:

80.3-91.1% of the air saturation value

Nominal and measured concentrations:

Nominal: 100 mg/L
Measured: 80 mg/L at 0 h and 22 mg/L at 24 h

Details on test conditions:

TEST SYSTEM
- Renewal rate of test solution (frequency/flow rate): every 24 h
- No. of organisms per vessel: 10 fish
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
Dechlorinated drinking water, pH 7.23, total hardness: 100.1 mg/L (CaCO3)

- Test process
Limit test of 100 mg/L was properly conducted before the definitive test. 4L test water was added to the vessel with cover, and 500 mL stock solution was used to rinse the flask and was added in. The test solution was transparent with little liquid drop at the bottom, which was renewed every 24 hours. 10 fish was placed in each vessel for 96 hours in the test system. At the same time, set up a blank control. The number of dead fish in each vessel was recorded every day and the dead fish was removed before the test solution was renewed.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 14 h illumination and 10 h dark
- Feed: No feed throughout the 96 h test period

TEST CONCENTRATIONS
- Limit study, 100 mg/L

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

Analysis of the samples taken from the test solution with the nominal concentration of 100 mg/L showed that the measured concentration was 80 mg/L at 0 hour and 22 mg/L at 24 hour.
The mortalities of the control and the test group were 0% during the 96 h test.

Validity criteria fulfilled:

yes

Conclusions:

The 96-LC50 of the test item (based on the nominal concentration) was >100 mg/L for Brachydanio rerio.

Executive summary:

Semi-static acute fish study in Brachydanio rerio was used to access the test item according to OECD Guideline 203 (Fish, Acute Toxicity Test).

Limit of 100 mg/L was properly conducted. 10 fish was placed in each vessel for 96 hours in the test system. At the same time, set up a blank control. The number of dead fish in each vessel was recorded every day and the dead fish was removed before the test solution was renewed.

 

Analysis of the samples taken from the test solution with nominal concentration of 100 mg/L showed that the measured concentration was 80 mg/L at 0 hour and 22 mg/L at 24 hour.

The mortalities of the control and the test group were 0 % during the 96 h test.

Under the condition of the test, the 96-LC50 of the test item (based on the nominal concentration) was >100 mg/L for Brachydanio rerio.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1997-12-09 to 1998-02-02

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:

adopted 17 July 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Batch No.: 9705-2A
Purity: 98.18%

Analytical monitoring:

yes

Details on sampling:

Four, mid-vessel samples (20 mL) were removed via a glass sampling tube from each control and test vessel before the addition of the fish at 0 and 48 hours ("fresh" media) and again at 24 and 72 hours from the expired media. Each sample was acidified using orthophosphoric acid (10 drops; analytical grade) as a precautionary measure to minimise any hydrolysis of the test material. On each sampling occasion, two of the samples were analysed immediately and the others were stored in a refrigerator in case further analysis was required.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: At each concentration, the test medium was prepared by injecting the appropriate volume of test material (45, 98, 216, 476, 1047 and 2300 μL) directly into dilution water in the aspirator (23 litres); the test material was warmed to liquefy it before use and the dilution water was aerated before the test material was added. Each aspirator was immediately sealed leaving no headspace and its contents were stirred overnight to mix the medium thoroughly.
- Controls: The control group comprised seven fish, placed in an aspirator containing dilution water (23 L).

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Source: Parkwood Trout Farm
- Length at study initiation: mean fork length was 4.7 cm
- Weight at study initiation (mean): 0.95 g
- Method of breeding:
- Maintenance of the brood fish:

ACCLIMATION
- Acclimation period: 14 d
- Acclimation conditions: not same as the test, held in an aerated supply of dilution water under flow-through conditions until removed for use in tests.
- temperatures ranged from 13.2 to 13.8°C
- pH values ranged from 7.5 to 7.8.
- dissolved oxygen concentrations (DO) ranged from 89 to 102% of the air saturation value (ASV)
- water hardness ranged from 198 to 210 mg/L as CaCO3
- Type and amount of food during acclimation: The fish were fed with proprietary trout pellets (TROUW UK Ltd, Nutra Trout Fry 02), an amount equivalent to between 1 and 4% of the total wet-weight of the fish in the holding tank.
- Feeding frequency during acclimation: Each day
- Health during acclimation: Mortality less than 2%.

FEEDING DURING TEST : not feed

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

206 to 214 mg/L as CaCO3

Test temperature:

14.1 to 15.1 °C

pH:

7.5 to 8.0

Dissolved oxygen:

79-114% ASV

Nominal and measured concentrations:

Nominal: 1.94, 4.27, 9.39, 20.7, 45.5 and 100 mg/L
Measured: 1.94 (nominal, below LOD), 4.39, 11.1, 19.4, 56.5 and 120 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aspirators, with a nominal total capacity of 23 litres, completely filled with media and sealed with glass lids secured with Parafilm
- Aeration: no
- Renewal rate of test solution: 24h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.41 g fish per litre

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Treatment involved blending tap water, previously filtered through activated carbon to remove chlorine, with tap water, which had been softened and treated by reverse osmosis, to achieve hardness in the range 200 - 250 mg/L as CaCO3. This water was held in an intermediate tank where it was equilibrated to the test temperature and gently aerated before being supplied to the holding and test areas.
For more details, refer to APPENDIX 2 Composition of the dilution water used in aquatic tests in attached background material.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light, provided by overhead fluorescent tubes, and eight hours dark.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Observations of the fish were made after 24, 48, 72 and 96 hours; additional observations were made during the first four hours.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2
- Range finding study
- Test concentrations: 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: After 96 hours, only one fish had died and the results of chemical analysis indicated that the measured concentrations were lower than intended and increased during the test. A number of preliminary tests were then conducted in which the procedure used to prepare the test media was modified to achieve exposure concentrations in the test media.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

74.2 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

After 96 hours, the highest measured concentration at which no more than one fish died was 56.5 mg/L and the lowest at which there was 100% mortality was 120 mg/L. At 11.1 mg/L, an aggressive fish was observed in the vessel; this was thought to have been responsible for the death of two fish at this level.
Sub-lethal, treatment-related effects, which were seen at all exposure levels, included darkened pigmentation, lethargy, nervous/erratic swimming behaviour, hyperventilation and loss of co-ordination.
At 19.4 to 120 mg/L, all fish were affected or had died within the initial two hours of exposure and within 72 hours at 11.1 mg/L. At 4.39 mg/L, the majority ofthe fish were affected after 96 hours of exposure. At 1.94 mg/L, at most, two fish exhibited minor symptoms at intervals during the test although at 96 hours, only one fish appeared dark.
At all concentrations, the test media were clear and colourless; their appearance did not change between renewals.

Reported statistics and error estimates:

Median lethal concentrations (LC50s) were estimated by the computer program of Stephan et al using the number of fish exposed and the number dead at each measured concentration.

Validity criteria fulfilled:

not specified

Conclusions:

Under semistatic exposure conditions, the 96-hour LC50 value of test item to the rainbow trout, calculated using measured concentrations, was found to be 74.2 mg/L, with 95% confidence limits of 56.5 and 120 mg/L. The NOEC was considered to be 1 mg/L (nominal value).

Executive summary:

The acute lethal toxicity of test item to the rainbow trout was assessed under semistatic exposure conditions over a period of 96 hours using methods based on OECD Procedure 203. Groups of seven fish were exposed to test itemat nominal concentrations of 1.94, 4.27, 9.39, 20.7, 45.5 and 100 mg/L or to dilution water alone. Because the test material was known to be volatile, the aqueous test media were prepared in glass aspirators which were completely filled leaving no headspace and sealed. To aid dissolution, the contents of the aspirators were stirred overnight in the test area before the fish were added. To maintain oxygen levels, the fish were transferred to fresh media every day.

After 96 hours, the highest measured concentration at which no more than one fish died was 56.5 mg/L and the lowest at which there was 100% mortality was 120 mg/L. At 11.1 mg/L, an aggressive fish was observed in the vessel; this was thought to have been responsible for the death of two fish at this level.

Sub-lethal, treatment-related effects, which were seen at all exposure levels, included darkened pigmentation, lethargy, nervous/erratic swimming behaviour, hyperventilation and loss of co-ordination.

At 19.4 to 120 mg/L, all fish were affected or had died within the initial two hours of exposure and within 72 hours at 11.1 mg/L. At 4.39 mg/L, the majority ofthe fish were affected after 96 hours of exposure. At 1.94 mg/L, at most, two fish exhibited minor symptoms at intervals during the test although at 96 hours, only one fish appeared dark.

At all concentrations, the test media were clear and colourless; their appearance did not change between renewals.

Under semistatic exposure conditions, the 96-hour LC50 value of test item to the rainbow trout, calculated using measured concentrations, was found to be 74.2 mg/L, with 95% confidence limits of 56.5 and 120 mg/L. The NOEC was considered to be 1 mg/L (nominal value).

Description of key information

- Key study:

The acute lethal toxicity of test item to the rainbow trout was assessed under semistatic exposure conditions over a period of 96 hours using methods based on OECD Procedure 203. 96-hour LC50 value was found to be 74.2 mg/L, with 95% confidence limits of 56.5 and 120 mg/L. The NOEC was considered to be 1 mg/L (nominal value).

- Supporting study:

Semi-static acute fish study in Brachydanio rerio was used to access the test item according to OECD Guideline 203 (Fish, Acute Toxicity Test). The 96-LC50 of the test item (based on the nominal concentration) was >100 mg/L for Brachydanio rerio.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

74.2 mg/L