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Description of key information

Short-term toxicity to fish

46.4 mg/l <LC50< 100 mg/l

Short-term toxicity to aquatic invertebrates

EC50 = 0.266 mg/l

Long term toxicity to aquatic invertebrates

LOEC = 1.5 mg/l

Toxicity to aquatic plants other than algae

ErC50 =   6.45 (5.09 – 7.88) mg/L based on frond number

ErC50 = 2.99 (2.48 – 3.66) mg/L based on dry weight

Additional information

Short-term toxicity to fish

The short-term toxicity to fish of the test substance was determined according to DIN 38 412 "Testverfahren mit wasserorganismen (gruppe l). allgemeine hinweise zur planung, durchfuehrung und auswertung biologischer testverfahren (ll)". The test was conducted at four different concentration: 10.0, 21.5, 46.4 and 100 mg/l. The LC50 value was found to be in a range of 46.4 mg/l and 100 mg/l.

This result is in line with a further test where the LC50 value calculated was 45 mg/l.

Short-term toxicity to aquatic invertebrates

No studies on "Toxicity to aquatic plants other than algae" are available on the Target Substance in itself. However a study conducted on a Similar Substance has been used for the assessment. Similar Substance 02 differ from the Target one only on the salification. More information are reported in section 13.

In the acute immobilization test with Daphnia magna (STRAUS), the effects of the test item were determined at the test facility according to OECD 202 (2004) from 2017-04-09 to 2014-04-12, with the definitive exposure phase from 2017-04-10 to 2017-04-12.

The study was conducted under static conditions over a period of 48 hours with five nominal concentrations of the test item ranging from 0.0625 to 1.00 mg/l in a geometric series with a separation factor of 2.

The test itemis a red powder, which is dispersible with water.All test item concentrations were visually clear throughout the exposure period. The concentration levels 0.250 to 1.00 mg/l showed a concentration-related strong to light orange colour. The concentration level of 0.125 mg/l was slightly orange in fresh medium and colorless in old medium. The orange colour was clearer in fresh media (0 hours) than in old media (48 hours) at the respective concentration levels. The concentration level 0.0625 mg/L was colourless throughout the exposure period.Twenty daphnids (divided into 4 replicates with 5 daphnids each) were exposed to each concentration leveland the control.

The concentrations of the test itemwereanalytically verified via LC-MS/MS in fresh media at the start of the exposure (0 hours) and in old media at the end of the exposure period (48 hours) in all tested concentration levels and in the control.

The measured concentrations of the test item in fresh media at the start of the exposure (0 hours) were in the range of 105 to 111 % of the nominal values in all test item concentrations. In old media at the end of the exposure period (48 hours), the measured test itemconcentrations were in the range of 97 to 104 % of the nominal values of the test concentrations.The measured concentrations of the test item remained stable within ± 20 % of the nominal concentrations throughout the exposure period and no hint for possible degradation products was observed in the respective chromatograms, which indicates that the test item concentrations were successfully maintained for the duration of the test.

All effect concentrations (EC10 / 50 / 100) are based on the nominal concentrations of the test item.

The validity criteria of the test guideline were fulfilled.

 

EC10-, EC50- (with 95 % Confidence Limits) and EC100-Values

(based on the nominal concentrations of the test item)

BasicRed 18.1 Chloride

Effect concentrations

 

Test

duration

[hours]

Toxicity endpoint
based on the nominal concentrations of the test item

[mg/L]

EC10

(with 95% confidence limits)

24

0.287

(Cl: 0.250 – 1.00)

48

0.145

(Cl:0.0625 – 0.195)

EC50

(with 95% confidence limits)

24

0.500

(Cl: 0.250 – 1.00)

48

0.266

(Cl: 0.227 – 0.319)

EC100

24

1.00

 

48

1.00

 

Long-term toxicity to aquatic invertebrates

Data on "Long-term toxicity to aquatic invertebrates" derives from tests carried out on an analogue molecule, with a different salification of the same core structure (Similar Substance 01). Further information are reported in the Read Across justification attached to section 13.

Different available tests may be valuable that gives information on long term toxicity to Daphnia.

The toxicity of the test substance to invertebrates was determined in two different tests, considered for the assessment in a weight of evidence approach, according to the Short Term Methods for Estimating the Chronic Toxicity of Effluentas and Receiving Waters to Freshwater Organisms, USEPA, 1985 (EPA/600/4-85/014).

The tests were both performed at four different concentrations: 1.5, 4.5, 9, 15 mg/l. Ten test organisms were exposed to each treatment in individual test chambers. Test solutions were renewed on days two and five with reproduction counts made at that time.

The LOEC value calculated in the first experiment was = 1.5 mg/l, while the NOEC calculated in the second test was = 15 mg/l. In a protective manner LOEC = 1.5 mg/l was considered the key value for the chemical safety assessment.

Toxicity to aquatic plants other than algae

No studies on "Toxicity to aquatic plants other than algae" are available on the Target Substance in itself. However a study conducted on a Similar Substance has been used for the assessment.

Similar Substance 02 differ from the Target one only on the salification. More information are reported in section 13.

The effects of the test item on the growth of the monocotyledonous aquatic plant species Lemna gibba was determined according to the principles of OECD 221.

Lemna gibba was exposed to the test item for 7 days under static conditions. Based on a preliminary test, 5 nominal test item concentration levels were tested in a geometrical series with a dilution factor of 2: 0.625 - 1.25 - 2.50 - 5.00 - 10.0 mg/L, corresponding to the geometric mean measured test item concentrations: 0.440 – 1.09 – 2.39 – 5.05 – 10.8 mg/L. Three replicates were investigated for each test concentration and six for the control. Frond numbers were assessed on days 0, 2, 5 and 7. Environmental parameters (light, pH and temperature) were within the acceptable limits. The validity criteria of the test guideline were fulfilled.

The concentrations of the test itemand the controlwere analysed via HPLC-DAD at the beginning and end of the exposure.

The measured concentrations at the start and the end of the exposure were in the range of 98 to 106 % and < LOQ to 110 % of the nominal values, respectively. All effect values are given based on the geometric mean measured test item concentrations. The EC50 value based on growth rate calculated in this test are:

ErC50 =   6.45 (5.09 – 7.88) mg/L based on frond number

ErC50 = 2.99 (2.48 – 3.66) mg/L based on dry weight

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), Part 4: Environmental Hazards, a substance shall can be classified for hazardous to the aquatic environment when the following criteria are met:

Category Acute 1:

96 hr LC 50 (for fish) < 1 mg/l and/or

48 hr EC 50 (for crustacea) < 1 mg/l and/or

72 or 96 hr ErC 50 (for algae or other aquatic plants) < 1 mg/l

Substances for which adequate chronic toxicity data are not available and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log K ow ≥ 4)

Category Chronic 1:

96 hr LC 50 (for fish) > 0.1 to ≤ 1 mg/l and/or

48 hr EC 50 (for crustacea) > 0.1 to ≤ 1 mg/l and/or

72 or 96 hr ErC 50 (for algae or other aquatic plants) > 0.1 to ≤ 1 mg/l

Despite the substance has chronic data available, they are not considered as sufficient for the assesment and the short -term toxicity to Daphnia studyprovides the lowest value that will be used for Classification:Category Chronic 1 and Category Acute 1 (H410).