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Endpoint summary

Description of key information

Short term toxicity to aquatic invertebrates

EC50(48h) = 6.63 mg/l, based on nominal concentration

Toxicity to aquatic algae and cyanobacteria

ErC50 (72h) = 38.3 mg/l, based on nominal concentration

Additional information

Short-term toxicity to aquatic invertebrates

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).

The study was conducted under semi-static conditions over a period of 48 hours withfiveconcentration levels of the test item of1.00 - 2.00 - 4.00 - 8.00 - 16.0 mg/Lin a geometric series with a separation factor of 2.

Twenty daphnids (divided into 4 replicates with 5 daphnids each) were exposed to each concentration level and the control.

The concentrations of the test item were analytically verified via spectrophotometric analysis in the fresh media at the start of the exposure and at the renewal of the test solutions (0 and 24 hours) as well as in the 24 hours old media at the renewal and at the end of the test (24 and 48 hours) in all concentration levels and in the control.

The measured concentrations of the test item in the fresh media were in the range of < LOQ to 116% at the start of the exposure (0 hours) and at the renewal (24 hours). The measured concentrations of the test item in the old media at the renewal and at the end of the test (24 and 48 hours) were in the range of < LOQ to 142%. The three lowest concentration levels could not be quantified, since the nominal test item concentrations were below the LOQ of the analytical method. The establishment of a method with a lower LOQ was not possible.

The EC_{10 / 50 / 100}-values given in the table belowwere based on the nominal concentrations of the test item.

The validity criteria of the test guideline were fulfilled.

 EC_{10 / 50 / 100}-Values(based on the nominal test item concentrations)

Effect levels	Test duration [hours]	VANADYL, BIS-2-HYDROXYACETATE Nominal test item concentrations [mg/L]
EC10 (with 95% confidence limits)	24	15.5 (95% Cl: 8.10 – > 16.0)
	48	4.55 (95% Cl: 3.88 – 5.52)
EC50 (with 95% confidence limits)	24	> 16.0 (95% Cl: not applicable)
	48	6.63 (95% Cl: 5.94 – 7.09)
EC100	24	> 16.0
	48	16.0

Based on the nominal concentration levels of the test item, the 48 hours-EC₅₀for Daphnia magna was 6.63mg/L (95% confidence limits: 5.94 – 7.09 mg/L).

Toxicity to aquatic algae and cyanobacteria

The toxicity of the test item to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined according to the principles of OECD 201 andCouncil Regulation (EC) No. 266/2016/Method C.3.The aim of the study was the determination of 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 5416 cells/mL. A stock solution with a nominal concentration of 100 mg test item/L was freshly prepared with dilution water. This dispersion was stirred for 30 minutes (room temperature, 1100 rpm) with a magnetic stirrer. The stock solution was checked via laser beam (Tyndall effect) for undissolved test item. The Tyndall effect was negative. Five concentrations were tested in a geometrical series with a spacing factor of √10: 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. The environmental conditionswere within the acceptable limits.

The concentrationsthe test itemwereanalytically verified via spectrophotometric analysis at the start (0 hours) and at the end of the exposure (72 hours).

The measured concentrations of the test item at the start of the exposure(0 hours) were in the range of < LOQ to 152% of the nominal values, after 24 hours < LOQ to 193%, after 48 hours < LOQ to 187% and at test end (72 hours) in the range of < LOQ to 181% of the nominal values.  

All effect values given are based on the nominal test item and are summarized as follows:

NOEC, LOEC, EC_x-values(0 - 72 hours)(based on the nominal test item concentrations, with 95% confidence intervals)

	Growth Rate Inhibition nominal test item concentrations, with 95% confidence intervals [mg/L]
NOEC	1.00
LOEC	3.16
ErC10	11.7 (8.98 – 15.3)
ErC20	19.5 (16.5 – 22.0)
ErC50	38.3 (35.8 – 42.3)
	Yield Inhibition nominal test item concentrations, with 95% confidence intervals [mg/L]
NOEC	< 1.00
LOEC	1.00
EyC10	n.a.
EyC20	3.40 (< 1.00 – 7.91)
EyC50	13.6 (10.3 – 18.2)

n.a. = not applicable

The EC₅₀-values for inhibition of growth rate (E_rC₅₀) and yield (E_yC₅₀) after 72 hours were 38.3 (35.8 – 42.3) mg/L and 13.6 (10.3 – 18.2) mg/L, respectively. The NOEC for inhibition of growth rate and yield was 1.00 and < 1.00 mg/L, respectively.

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 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) 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

The substance under investigation has toxic effects on both throphic level, however the Daphnia results to be the most sensitive species with an effect level (EC50) of 6.63 mg/l, based on nominal concentration. For this reason the proposed classification for this substance is Aquatic Chronic Category 2, according to the CLP Regulation (EC 1272/2008).