sodium 5-(4-amino-6-(4-((E)-4-(4-(bis(2-hydroxyethyl)amino)-6-(8-hydroxy-7-((E)-phenyldiazenyl)-3,6-disulfonatonaphthalen-1-ylamino)-1,3,5-triazin-2-ylamino)-2-sulfonatostyryl)-3-sulfonatophenylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-3-((E)-phenyldiazenyl)naphthalene-2,7-disulfonate

Endpoint summary

Description of key information

Short-term toxicity to aquatic invertebrates

EC50 (48h) > 100 mg/l

Toxicity to aquatic plants other than algae

EC50 (7d) > 352 mg/l

Additional information

No information on the "aquatic toxicity" of the Target Substance is available. However data on a Similar Substance has been taken into account for the assessment. More details on the substance similarity are reported in section 13.

Short-term toxicity to aquatic invertebrates

In the acute immobilisation test with Daphnia magna (STRAUS), the effects of the limit concentration of 114 mg/L test item were determined under static conditions over a period of 48 hours according to OECD 202 (2004), equivalent to the Council Regulation (EC) No 440/2008 Method C.2 (2008). A stock solution of 114 mg/L of the test item was freshly prepared with dilution water before the start of the exposure (at 0 hours), homogenised by manual agitation and used for testing. Corrected for purity, the limit concentration was 100 mg/L of pure (anhydrous) substance. The test item solution was red coloured and visually clear throughout the exposure period. Twenty daphnids were exposed to the limit concentration and the control. The concentrations of the test item were analytically verified via spectrophotometric analysis at the start (0 hours) and at the end of the exposure (48 hours) in the limit concentration and the control. The measured concentration in the limit concentration of the test item at the start of the exposure (0 hours) was 107 mg/L and 106 mg/L at the end of the exposure (48 hours). The measured test item concentrations were within ± 20 % of the nominal concentration. This indicates that the limit test item concentration was successfully maintained for the duration of the test. Therefore, the effect levels were based on the nominal concentration of the test item, corrected for purity. The water quality parameters (i.e. pH-value and dissolved oxygen concentration), measured at the start (0 hours) and at the end of the exposure (48 hours), were within the acceptable limits. The validity criteria of the test guidelines were fulfilled. At the limit concentration of 114 mg/L of the test item, which is equivalent to 100 mg/L pure (anhydrous) substance, no effects were observed on Daphnia magna. In conclusion, the following endpoint values were determined on the basis of the nominal test item concentrations, corrected for purity after 24 h and 48 h of exposure: EC10-, EC50- and EC100-value is greater than 100 mg/L.

 

Toxicity to aquatic plants other than algae

The effects of test item on the growth of the monocotyledon species Lemna gibba was determined according to the principles of OECD 221 under GLP conditions. Each test concentration was freshly prepared with dilution water from a stock solution of 400 mg/L. The tested solutions were visually clear throughout the exposure. A semi-static exposure over 7 days was carried out. Based on a preliminary test, 5 nominal test item concentration levels were tested in a geometrical series with a dilution factor of 2.5: 10.2 - 25.6 -64 - 160 - 400 mg test item/L. Corrected for purity, the test concentrations were 8.98 - 22.5 - 56.3 - 141 - 352 mg/L. Three replicates were investigated for each test concentration and six for the control. Frond numbers were assessed on days 0, 3, 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 item and the control were analysed via spectrophotometric analysis at the beginning and end of the exposure and at every renewal day. Freshly prepared and old media were analysed. The measured concentrations of the test item in the fresh and old test media were in the range of 89 to 95 % and 92 to 103 % of the nominal values, respectively. All effect values are given below based on nominal test item concentration, corrected for purity.

 

Based on frond number (after 7 days):

NOEC (growth rate): 56.3 mg/L

LOEC (growth rate): 141 mg/L

ErC50: > 352 mg/L

ErC20: > 352 mg/L

ErC10: 52.4 mg/L (95% confidence limits 25.5 - 103)

NOEC (Yield): 56.3 mg/L

LOEC (Yield): 141 mg/L

EyC50: > 352 mg/L

EyC20: 65.4 mg/L (95% confidence limits < 8.98 – 140)

EyC10: < 8.98 mg/L

 

Based on dry weight (after 7 days):

NOEC (growth rate): < 8.98 mg/L

LOEC (growth rate): 8.98 mg/L

ErC50: > 352 mg/L

ErC20: 32.8 mg/L (21.8 - 45.8)

ErC10: < 8.98 mg/L

NOEC (Yield): < 8.98 mg/L

LOEC (Yield): 8.98 mg/L

EyC50: 58.1 (95% confidence limits 40.0 - 84.9)

EyC20: < 8.98 mg/L

EyC10: < 8.98 mg/L

Justification for classification or non-classification

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

A )Acute (short-term) aquatic hazard

Category Acute 1: 96 hr LC 50 (for fish) and/or 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤ 1 mg/l

B) Long-term aquatic hazard

(iii) Substances for which adequate chronic toxicity data are not availableand 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) and/or 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤ 1 mg/l

Category Chronic 2: 96 hr LC 50 (for fish) and/or 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants)> 1 to ≤10 mg/l

Category Chronic 3:96 hr LC 50 (for fish) and/or 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) > 10 to ≤ 100 mg/l

Based on the above results, the test substance has not been classified for aquatic toxicity.