3-fluoro-4'-(trans-4-propylcyclohexyl)-1,1'-biphenyl

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 18, 2013 - February 19, 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Version / remarks:

2012

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 100 mg/L
- Sampling method: The limit concentration of the test item and the control were analysed by HPLC-DAD at the start of the exposure intervals (0h) on days 0, 10, 17 and at the end of the exposure intervals on days 3, 12, 19 (48 or 72h). For the analyses at the end of the exposure intervals, seperate replicates without algae and daphnids were prepared and stored under test condictions until sampling.
- Sample storage conditions before analysis: All original and prepared samples were stored at room temeperature.

Vehicle:

yes

Remarks:

Elendt M4, according too ELENDT (1990), modified to a total hardness of 160 to 180 mg CaCO3/L

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A saturated solution (100 mg/L) was prepared with dilution water one day before start of each exposure interval. The test item (100 mg/L) was tranferred with an appropriate amount of the dilution water into brown glass flask and shaken overhead with 20 rpm for 24 hours at room temperature. Undissolved test item was removed by filtration with a membrane filter (0.45 µm, RC, Machery-Nagel).
- Vehicle: Elendt M4, according too ELENDT (1990), modified to a total hardness of 160 to 180 mg CaCO3/L

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: Daphnia magna Straus (Clone 5)
- Source: lnstitut für Wasser-, Boden- und Lufthygiene (WaBolu)
- Breeder: DR.U. NOACK-LABORATORIEN, Käthe-Paulus-Str. 1, 31157 Sarstedt, Germany
- Feeding during test: Daily feeding per test vessel with Pseudokirchneriella subcapitata (0.204 - 0.231 mL) and Desmodesmus subspicatus (0.195 - 0.213 mL) suspension was provided as food corresponding to 0.2 mg C per Daphnia and day.

ACCLIMATION
- Acclimation period: At least 2h in dilution water
- Acclimation conditions: same as test
- Type and amount of food: At least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus, with an algae cell density of > 10^6 cells/mL

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

21 d

Hardness:

160 - 183 mg/L CaCO3

Test temperature:

20.3 - 22.4°C

pH:

7.53 - 8.54

Dissolved oxygen:

5.02 - 9.63 mg/L

Nominal and measured concentrations:

Nominal concentration: 100 mg/L
Measured Concentration: 1.08 µg/L (geometric mean measured concentration)

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers 100 mL capacity
- Volume of test medium: 50 mL
- Type : open
- Renewal rate of test solution: renewal 3 times per week, i.e. after 48 and 72 hours
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10

TEST MEDIUM / WATER PARAMETERS
- Culture medium Elendt M4, according to ELENDT ( 1990), modified to a total hardness of 160 to 180 mg CaC03/L
- Culture medium different from test medium: no
- Intervals of water quality measurement: once within 7 days

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16/8h light/dark cycle
- Light intensity: Max. 20 µE m-2 s-1

TEST CONCENTRATIONS
- Range finding study: A non GLP preliminary range finding test was carried out at the test facility as acute immobilisation test to Daphnia magna STRAUS. A limit loading rate of 100 mg/L of the test item was tested under static conditions over a period of 48 h and no immobilisation was seen.

Reference substance (positive control):

yes

Remarks:

A reference test was conducted as an acute immobilisation test (acc. to OECD 202 and AQS P 9/2) under static conditions with a test duration of 24h once per month.

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 1.08 µg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: >= 100 mg/L (nominal); NOEC = solubility limit

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 1.08 µg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: >= 100 mg/L; NOEC = solubility limit

Details on results:

The measured concentrations of the test item at the start of the exposure intervals were in the range of 0.724 to 2.15 µg/L. At the end of the exposure intervals (48 or 72 h), the measured concentrations of the test item were in the range of 0.272 to 1.85 µg/L. The geometric mean measured concentration of the test item was calculated to be 1.08 µg/L and was used for the assessment of the effect levels.

The average values of living juveniles per parental daphnid was 77 for the control and 75 for the geometric mean measured concentration of 1.08 µg/L after 21 days. The reproductive output of daphnids in the geometric mean measured concentration of 1.08 µg/L was comparable to the reproductive output of daphnids in the control (t-test, p = 0.05).

The coefficient of varation of the number of living offspring produced per parent was 7% for the control and 6% for the geometric mean measured concentrwation of 1.08 µg/L. Generally in a well-run test, the coefficient of varation around the mean number of living offspring per parent animal should be <= 25%.

The intrinsic rates of natural increase (IR) of the surviving parental daphnids accounting for generation time and number of offspring were used for calculation of population growth and maintenance. The intrinsic rates of the geometric mean measured concentration of 1.08 µg/L were comparable to those in the control (t-test, p= 0.05).

No adult mortality was observed during the test period of 21 days. In the geometric mean measured concentration of 1.08 µg/L and in the control, all parental daphnids survived until the end of the test after 21 days.

The first brood was released between days 8 and 9 by all parental daphnids of the control and the geometric mean measured concentration of 1.08 µg/L. At the geomtric mean measured concentration of 0.281 µg/L and the control, 4 broods were produced by all parental daphnids.

The mean dry body weight and total body length of all parental daphnids of the geometric mean measured concentration of 1.08 µg/L and the control were determined at the end of the study. The mean dry body weight of the parental daphnids was 1.05 mg per daphnid for the control and 1.06 mg per daphnid for the geometric mean measured concentration of 1.08 µg/L. The mean body length of the parental daphnids was 5.00 mm per daphnid for the control and 4.95 mm per daphnid for the geometric mean measured concentration of 1.08 µg/L.

No stillborn juveniles or aborted eggs were observed in the control and in the geometric mean measured concentration of 1.08 µg/L during the exposure period of 21 days.

No males or ephippia (winter eggs) were observed in the control or in the geometric mean measured concentration of 1.08 µg/L.

Water quality parameters (i.e. pH-value, dissolved oxygen concentration, total water hardness and temperature) were within the acceptable limits.

Results with reference substance (positive control):

The EC50 of the reference item ptassium dichromate was 1.92 mg/L (95% confidence limits: 1.74 - 2.11 mg/L) after 24 hours and therefore within the prescribed concentration range of 0.6 - 2.4 mg/L of quality criteria according to AQS P 9/2 (05/1996) for daphnids clone 5 cultured in Elendt M4 medium. The EC50-value of the reference item is also within the recommended rangeof 0.6 - 2.1 mg/L according to OECD-Guideline 202.

Validity criteria fulfilled:

yes

Conclusions:

No significant effects on the reproductive output or adult mortality were observed in this study. The No Observed Effect Concentration (NOEC) after 21 days was assessed at 1.08 µg/L, which is the maximum solubility level of the test item in the dilution water.

Executive summary:

The Daphnia magna Reproduction Test (Semi-Static, 21 d) was conducted as a limit test with a saturated solution of the test item, prepared with a nominal loading of 100 mg/L, according to OECD 211 (2012).

The test species was Daphnia magna STRAUS (Clone 5). Ten daphnids individually held were used for the saturated solution and the control. At the start of the exposure, the daphnids were

to 24 h old. The test method was semi-static with renewal of the test solutions three times per week. The aim of the Daphnia Reproduction Test over 21 days was to assess effects on the reproduction capacity and other test item-related effects on parameters such as intrinsic rate of natural increase, occurrence of aborted eggs and stillborn juveniles, time of release of the first brood, adult mortality, dry body weight and body length of the parental daphnids.

The concentrations of the test item were analytically verified via HPLC-DAD of samples taken at the start of the exposure intervals on days 0, 10, 17 (0 h) and at the end of the exposure intervals on days 3, 12, 19 (48 or 72 h) of the saturated solution and the control.

The measured concentrations of the test item at the start of the exposure intervals were in the range of 0.724 to 2.15 µg/L. At the end of the exposure intervals (48 or 72 h), the measured concentrations of the test item were 0.272 to 1.85 µg/L.

The geometric mean measured concentration of the test item was calculated to be 1.08 µg/L and was used for the assessment of the effect levels.

        

The average values of living juveniles per parental daphnid were 77 for the control and 75 for the geometric mean measured concentration of 1.08 µg/L after 21 days. The reproductive output of daphnids in the geometric mean measured concentration of 1.08 µg/L was comparable to the reproductive output of daphnids in the control (t-test, p = 0.05).

 

The coefficient of variation of the number of living offspring produced per parent was 7 % for the control and 6 % for the geometric mean measured concentration of 1.08 µg/L. Generally, in a well-run test, the coefficient of variation around the mean number of living offspring per parent animal should be <= 25 %.

 

The intrinsic rates of natural increase (IR) of the surviving parental daphnids accounting for generation time and number of offspring were used for calculation of population growth and maintenance. The intrinsic rates of the geometric mean measured concentration of 1.08 µg/L were comparable to those in the control (t-test, p = 0.05).

 

No adult mortality was observed during the test period of 21 days. In the geometric mean measured concentration of 1.08 µg/L and in the control, all parental daphnids survived until the end of the test after 21 days.

 

The first brood was released on days 8 and 9 by all parental daphnids of the control and the geometric mean measured concentration of 1.08 µg/L.

At the geometric mean measured concentration of 1.08 µg/L and the control, 4 broods were produced by all parental daphnids.

 

The mean dry body weight and total body lengths of all parental daphnids of the geometric mean measured concentration of 1.08 µg/L and the control were determined at the end of the study.

The mean dry body weight of the parental daphnids was 1.05 mg per daphnid for the control and 1.06 mg per daphnid for the geometric mean measured concentration of 1.08 µg/L.

The mean body length of the parental daphnids was 5.00 mm per daphnid for the control and 4.95 mm per daphnid for the geometric mean measured concentration of 1.08 µg/L.

 

No stillborn juveniles or aborted eggs were observed in the control and in the geometric mean measured concentration of 1.08 µg/L during the exposure period of 21 days.

 

No males or ephippia (winter eggs) were observed in the control or in the geometric mean measured concentration of 1. 08 µg/L.

 

Water quality parameters (i.e. pH-value, dissolved oxygen concentration, total water hardness and temperature) were within the acceptable limits.

 

In order to prove the validity of the test system and test conditions at the test facility, an acute immobilisation test according to AQS P 9/2 and OECD 202 is monthly carried out with potassium dichromate as reference item.

The EC50 of the reference item was 1.92 mg/L (95% confidence limits: 1.74 - 2.11 mg/L) after 24 hours and therefore within the prescribed concentration range of 0.6 - 2.4 mg/L of quality criteria according to AQS P 9/2 (02/2000) for daphnids clone 5 cultured in Elendt M4 medium. The ECso-value of the reference item is also within the recommended range of 0.6

- 2.1 mg/L according to OECD-Guideline 202.

 

No biologically significant effect could be determined in the geometric mean measured concentration of 1.08 µg/L in comparison to the control.

 

Reference 2

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

For this endpoint information from structural similar compounds (CAS 132123-39-8) is available. The studies for these similar compounds were performed according to GLP and the methods applied are fully compliant with OECD TG 211. See chapter 13 report for a more detailed justification.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Version / remarks:

2012

Deviations:

no

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 1.08 µg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: >= 100 mg/L (nominal); NOEC = solubility limit

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 1.08 µg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: >= 100 mg/L (nominal); NOEC = solubility limit

Description of key information

A Daphnia magna Reproduction Test with a structural analogue substance was conducted. No significant effects on the reproductive output or adult mortality were observed in this study. The No Observed Effect Concentration (NOEC) after 21 days was assessed at 1.08 µg/L, which is the maximum solubility level of the test item analogue in the dilution water. The nominal NOEC is >= 100 mg/L.