3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol

Long-term toxicity to fish

Administrative data

Endpoint:

long-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

3 (not reliable)

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Method for Testing the Degree of Accumulation of Chemical Substances in Fish Body. July 13, 1974, Revised October 8, 1998, Kanpogyo No.5, Planning and Coordination Bureau, Environment Agency

Deviations:

yes

Remarks:

(No post-exposure (depuration) phase)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)

Deviations:

yes

Remarks:

(No post-exposure (depuration) phase)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol

EC Number:

211-477-1

EC Name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol

Cas Number:

647-42-7

Molecular formula:

C8H5F13O

IUPAC Name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol

Details on test material:

- Purity: 99.8 wt%

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Sampling intervals/frequency for test organisms: The test fish of Level 1 and 2 were analysed five times in duration of exposure. Four fish were taken out at each sampling time and divided into two groups, then both were analysed individually. Because one fish was too small to take out the stored sample for the measurement of lipid content, two fish a group were employed.
The control fish were analysed before the experimental starting and after the experimental completion. Four fish were taken out at each sampling time and divided into two groups, and then each was analysed individually. In addition, two fish were taken out and three groups (two fish per group) were used for measurement of lipid contents.
- Sampling intervals/frequency for test medium samples: The test water of each level was analysed once before first analysis of test fish and at the same time as analysis of test fish thereafter. The number of each sample was one .
- Details on sampling and analysis of test organisms and test media samples: Analysis of test item in test water and test fish was performed with gas chromatography-mass spectrometry (GC-MS) analysis. If the test item was bioaccumulated in the. test fish, the test item had a possibility to be metabolised in the fish body. Therefore, C5F11COOH (hereafter mentioned as "carboxylic acid" ) which was an estimated metabolite of the test item in the test fish was analysed at the same time. Analysis of the carboxylic acid in the test fish was performed with the liquid chromatography - tandem mass spectrometry (LC/MS/MS).

Test solutions

Vehicle:

yes

Details on test solutions:

PREPARATION OF SPIKED WATER
Preparation of stock solution
- Dispersant
HCO-20 (Hydrogenated castor oil)
- Preparation
The item supplied by the sponsor and HCO-20 (20 times amount of it) were mixed and kneaded. And ion-exchanged water was added to the mixture to prepare 1000 mg/L stock solution.

Test organisms

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Carp
- Source: Sugishirna fish farm, Japan
- Age at study initiation: Yearling fish
- Length at study initiation: 6.6 - 6.8 cm
- Health status: The fish were checked visually at receipt and those showing any abnormalities were removed.
- Description of housing/holding area: 100-L glass tank
- Feeding during test: yes
- Food type: Feed for fry of carp
Proteins content ≥ 43.0 %
Lipid content ≥ 3.0 %
Manufacturer Nippon Fonnula Feed Mfg. Co., Ltd.
- Amount: Amount corresponding to about 2 % of total body weight was fed twice a day in halves.
- Frequency: Amount corresponding to about 2 % of total body weight was fed twice a day in halves. The fish were starved for 24 hours before sampling.

ACCLIMATION
- Acclimation period: flow-through system for 41 days
- Acclimation conditions (same as test or not): same

Study design

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

28 d

Test conditions

Hardness:

58.6 mg/L

Test temperature:

24.6 - 25.9 °C

pH:

7.6 - 7.9

Dissolved oxygen:

7.0 -8.0 mg/L

Salinity:

fresh water

Nominal and measured concentrations:

Nominal concentrations:
High exposure level (Level 1) - 10 µg/L
Low exposure level (Level 2) - 1 µg/L

Mean Measured:
High exposure level (Level 1) - 9.11 µg/L
Low exposure level (Level 2) - 0.835 µg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 100-L glass tank
- Type of flow-through: 0.02 mL/min for stock solution and 1600 mL/min for dilution water, 2304 L/day of test water, was supplied.
- Renewal rate of test solution: 2304 L/day of test water
- No. of organisms per vessel: test - 29; control - 12
- No. of vessels per concentration (replicates): 1
- No. of vessels per control / vehicle control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Groundwater from the premises of Kurume Laboratory.
It was confirmed that the dilution water met the ministerial ordinance of the Ministry of Health and Welfare (December 21, 1992), water quality criteria for fisheries (Shadanhozin Nihon Suisansigen Hogokyokai, March 1983), OECD Guidelines for Testing of Chemicals, "Fish, Early-life Stage Toxicity Test" (Guideline 210, July 17, 1992) and environmental quality standards for water pollutants No.14 (Revised February 22, 1999, Environment Agency) or OECD Guidelines for Testing of Chemicals, "Bioconcentration: Flow-through Fish Test (Guideline 305, June 14, 1996)".

RANGE-FINDING / PRELIMINARY STUDY
- Test concentrations: 0.854, 1.88, 4.13, 9.09 and 20.0 mg/L
- Results used to determine the conditions for the definitive study: yes, 96-hour LC50 value 10.4 mg/L

Results and discussion

Effect concentrations

Dose descriptor:

other: NOEC not determined directly, NOEC value of 10 ug/L inferred from study design.

Details on results:

- Mortality of test organisms: none

Any other information on results incl. tables

Results of test fish observation - no abnormality in behaviour or appearance was noted.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability).
Results of test fish observation - no abnormality in behaviour or appearance was noted.

Executive summary:

A fish bioconcentration test was conducted for 28 days on common carp with two exposure levels of the test substance. Bioconcentration values for the test substance and a metabolite, carboxylic acid, were determined. The 28 day carp study is not technically a chronic study BUT no effects were seen after 28 days exposure to nominal 1 and 10 µg/L concentrations. There was no mortality or abnormality in behaviour or appearance.