Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

TOXICITY TO FISH

 

Short-term toxicity to fish

 

Two key studies showed that the nominal 96 hour LC50 value of the test item to rainbow trout (Salma gairdneri) was clearly about 100 mg/L. In one study a LC50 value of 509 mg/L was reported and in the other no toxic effects was found up to the tested concentration of 100 mg/L.

 

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).

TOXICITY TO DAPHNIA

 

Short-term toxicity to aquatic invertebrates

The 24 and 48 hour median effective concentrations oft he test item tot he freshwater crustacean Daphnia magna (<24 hours old) were determined und static test conditions at a temperature of 20 +/- 1 °C.

The median effective concentration (EC50) was defined as the concentration, calculated from the data obtained, resulting in immobilization of 50% of the daphnia in the time period specified.

 

The values obtained (and their 95% confidence limits) were:

24 h EC50: 200 (140 – 390) mg/L

48 h EC50 26 (23 – 30) mg/L

 

The measured concentrations of the test material at the start and finish of the test ranged from86% to 100% of the nominal values.

 

Long-term toxicity to invertebrates

 

The influence of the test item on reproduction and survival rate of daphnia magna was investigated in a 21 days semistatic test according to the OECD Guideline for testing of Chemicals, Section 2, No. 202, adopted 4 April 84.

 

The test was performed in a compliance with the Good Laboratory practice Regulations.

 

The nominal concentrations tested were 1.0, 3.2, 10.0, 32.0 and 100 mg test article/L and a control without any additions.

 

The test results:

 

Highest concentration tested without toxic effects (NOEC): 10 mg test article/L

Lowest concentrations tested with toxic effects (LOEC): 32.0 mg test article/L

 

In the concentration of 10 mg test article/L the analysed concentrations in the freshly prepared test media amounted in the mean to 82.4 % of the nominal value. In the freshly prepared test media of the concentration of 100 mg/L on day 0 only 54.4 % of the nominal value was measured, but in the lower concentration of 10 mg/L, prepared in sequential dilutions out of the higher concentrations, the measured concentration amounted to 84.7 % at that date. On the next analytical date 90.5 % of the nominal value of the concentration of 100 mg test article/L was determined. Since in the samples of the stock solutions always concentrations between 81.3 and 88.7 % of the nominal values were measured and the test article was sufficiently stable under test conditions, all reported results are related to the nominal concentrations of the test article.

 

TOXICITY TO AQUATIC ALGAE

The influence oft he test item on the growth oft he green alga Scenedesmus subscitatus was investigated.

 

The study was performed according to the OECD Guideline 201. In the study, concentrations in the range 0.3125 mg/L to 80 mg/L were tested.

 

Based on the growth inhibition curve, The NOEC and LOEC values after 72 and 96 hours were found to be 20 mg/L and 80 mg/L, respectively. The EbC50 values after 72 and 96 hours were 27.1 mg/L and 24.2 mg/L, respectively.

 

The analytical results can be summarized s follows:

Nominal concentration (mg/L)

Time

(hours)

% of nominal

5.0

0

74.0

5.0

96

72.4

20

0

91.4

20

96

98.2

80

0

113.1

80

96

97.6

 

TOXICITY TO MICROORGANISMS

A Respiration Inhibition Test with activated sludge according to OECD Guideline No. 209 was carried out with the test item at theDr.U.Noack-Laboratorien, 31157Sarstedt, Germany.Test system was activated sludge of the municipal treatment plant of 31137 Hildesheim, Germany. The test was carried out under static conditions with the substance concentrations 750 and 1000 mg/L (a.i.), corresponding to the nominal test item concentrations 797 and 1064 mg/L. The respiration rates of the control, reference and test item replicates were measured after a contact time of three hours, and the inhibitory effects of the test and reference item were determined in comparison to the control respiration rates. The mean inhibition of respiration for the test item replicates was -9 % and    -5 %.

In order to check the activity of the test system and the test conditions a reference test was carried out with copper (II) sulphate pentahydrate as reference item and the reference toxicity was determined. The EC50-value for the reference item was 115 mg/L.

NOEC and EC-Values of the test item

EC-values

[mg a.i./L]

NOEC

1000

EC20

> 1000

EC50

> 1000

EC80

> 1000