Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Short-term toxicity to fish

The reported 96-hour LC50 is between 10 and 100 mg/L. At a concentration of 100 mg/L effects was shown and 100% mortality is reported. The test concentration of 10 mg/L shows no effect.

Long-term toxicity to fish

Waiving according to "column 2" in Annex IX of REGULATION (EC) No 1907/2006 (CSA does not indicate need for further investigations)

Short-term toxicity to daphnia

In the acute immobilisation test withDaphnia magna( STRAUS), the effects of the test item were determined according to OECD 202 (2004) from2013-02-13 to 2013-02-19, with the definitive exposure phase from 2013-02-13 to 2013-02-15, atDr.U.Noack-Laboratorien, Käthe-Paulus-Str.1, 31157 Sarstedt, Germany.

The study was conducted under static conditions over a period of 48 h with5concentration levels of the test itemAfilan V5760in the range of1.25 to 20.0 mg/L. The test item concentrations were prepared with dilution water in a geometric series with a separation factor of2and homogenised by agitation. Twenty daphnids were exposed to each concentration leveland the control.

The test item concentrations ofAfilan V5760wereanalytically verified by LC-MS/MS at the start of the exposure (0 h) and at the end of the exposure (48 h) in all concentration levels and the control. Details of the analytical method are presented in part11.

The measured concentrations of the test itemAfilan V5760at the start of the exposure (0 h) were in the range of 93 to 116 % of the nominal values. The measured concentrations of the test item at the end of the exposure (48 h) were in the range of 94 to 104 % of the nominal values.The analytical results are presented inTable6.

The measured concentrations were in the range of± 20 % of the nominal values, which demonstrates, that the test item concentrations were successfully maintained for the duration of the test.All effect levels are based on the nominal concentrations of the test itemAfilanV5760(Table1).

The water quality parameters (i.e. pH-value and dissolved oxygen concentration), measured at the start (0 h) and at the end of the exposure (48 h), were within the acceptable limits. The validity criteria of the test guideline were fulfilled.

 

Table1:   EC10-, EC50- (with Confidence Interval), EC100- Values, NOEC and LOEC

(based on the nominal concentrations of the test item)

Endpoints

Test

duration

[h]

Afilan V5760

Nominal
test item concentrations

[mg/L]

95 % confidence limits

 

[mg/L]

EC10

24

    6.66

4.62 – 8.52

48

    5.73

4.23 – 7.77

EC50

24

    8.63

7.31 – 9.74

48

    8.58

6.79 – 9.52

EC100

24

> 20.0

Not applicable

48

  20.0

Not applicable

NOEC

48

    5.00

Not applicable

LOEC

48

  10.0

Not applicable

 

Long-term toxicity to daphnia

Waiving according to "column 2" in Annex IX of REGULATION (EC) No 1907/2006 (CSA does not indicate need for further investigations)

Toxicity to algae

The toxicity ofAfilan V5760 to the unicellular freshwater green algaDesmodesmus subspicatuswas determined according to the principles of OECD 201atDr.U.Noack-Laboratorienin 31157 Sarstedt, Germanyfrom2013-02-05 to 2013-02-19, with the definitive exposure phase from 2013-02-05 to 2013-02-08.The aim of the study was to assess the effects on growth rate and yield over a period of 72 hours.

The study was conducted under static conditions with an initial cell density of 4332 cells/mL.Based on a preliminary test 5concentration levels were tested in a geometrical series with a dilution factor of(nominal):1.00 - 3.16 - 10.0 - 31.6 - 100 mg/L.Three replicates were tested for each test item concentration and six replicates for the control.Environmental conditionswere determined to be within the acceptable limits.

The concentrations ofAfilanV5760were analytically verified by LC-MS/MS at test start and test end of all test concentrations and the control. Details of the analytical method are presented in part9. The analytical results are presented inTable8.

The measured concentrations ofAfilanV5760at test start were in the range of 87 to 106 % of the nominal values. At test end the recoveries were in the range of 101 to 104 % of the nominal values. Therefore, all effect values given are based on the nominal concentrations of the test itemAfilanV5760(seeTable1).

 

Table1:  NOEC, LOEC, EC - values and 95 % Confidence Intervals ofAfilanV5760(0-72 hours)

                  based on nominal test item concentrations [mg/L]

 

Growth Rate Inhibition

NOEC

3.16

LOEC

10.0

ErC10

8.35 (3.16 – 10.0)

ErC20

8.92 (3.16 – 10.0)

ErC50

9.98 (3.16 – 31.6)

 

Yield Inhibition

NOEC

3.16

LOEC

10.0

EyC10

6.77 (3.16 – 10.0)

EyC20

7.23 (3.16 – 10.0)

EyC50

8.08 (3.16 – 10.0)

Toxicity to microorganisms

The EC50 of the test item was reported as 367 mg/L. The EC10 is 118 mg/l