Hydrogen [3-[[1-[anilinocarbonyl]-2-oxopropyl]azo]-2-hydroxy-5-nitrobenzene-1-sulphonato(3-)]hydroxychromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017-07-01 to 2017-08-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen [3-[[1-[anilinocarbonyl]-2-oxopropyl]azo]-2-hydroxy-5-nitrobenzene-1-sulphonato(3-)]hydroxychromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

EC Number:

304-519-6

EC Name:

Hydrogen [3-[[1-[anilinocarbonyl]-2-oxopropyl]azo]-2-hydroxy-5-nitrobenzene-1-sulphonato(3-)]hydroxychromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

Cas Number:

94276-33-2

Molecular formula:

C16 H12 Cr N4 O9 S . C11 H25 N O . H

IUPAC Name:

hydrogen 3-[(2-ethylhexyl)oxy]propan-1-amine 11-methyl-4-nitro-12-(phenylcarbamoyl)-6-sulfonato-8λ³-oxa-10λ³-oxa-1λ⁴,13-diaza-9-chromatricyclo[7.4.0.0²,⁷]trideca-1(13),2(7),3,5,10-pentaene-9,9,9-tris(ylium)-8,12-diid-9-olate

Test material form:

solid

Details on test material:

Physical state / Appearance: Solid / orange to brown

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature, without exposure to light in a tightly sealed container.

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Samples of all fresh test item concentrations and the control at exposure initiation and all 24-hour-old test item concentrations and the control at renewal were determined. Moreover, samples of fresh test item concentrations (filtrate of a loading of 10 mg/L, filtrate of a loading of 100 mg/L, control at renewal) as well as 24-hour-old test item concentrations (filtrate of a loading of 10 mg/L, filtrate of a loading of 100 mg/L, the control at exposure termination) were determined.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
The test item is a complex mixture which in incompletely soluble in water. The composition of the soluble fraction changes with the loading. Thus the definitive test was performed using test item concentrations: filtrate of a loading of 100 mg/L, filtrate of a loading of 57 mg/L, filtrate of a loading of 32 mg/L, filtrate of a loading of 18 mg/L, filtrate of a loading of 10 mg/L, plus the control. Appropriate amounts of the test item were weighed separately in glass flasks with ISO test water and mixed with an appropriate volume of the ISO test water [SOP/W/7]. The mixtures were heterogeneous (with non-dissolved particles on the surface). The mixtures and the control (500 mL ISO test water) were left for mechanical shaking for 48 hours (90 revolutions per minute, darkness, room temperature). After 48 hours of mechanical shaking, the mixtures were heterogeneous (visible particles on the surface and bottom of the flask). All mixtures and the control were filtrated through a conditioned nitrocellulose membrane filter (HAWG filter, 0.45 µm, Millipore), [SOP/W/37]. Each filtrate was visually homogeneous (without any visible non-dissolved particles) transparent and colored. The test vessels were conditioned with test item concentrations/control before exposure initiation. The test item concentrations were visually homogeneous, transparent and colored directly after preparation and throughout exposure period.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Strain: STRAUS
- Source: the test organism originated from the standard laboratory culture cultivated at the Institute of Industrial Organic Chemistry, Branch Pszczyna, Department of Ecotoxicology.
- Age of parental stock (mean and range, SD): Daphnia magna Straus (< 24 h old at exposure initiation); not first brood progeny; neonates collected from the laboratory culture
- Feeding during test: No

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

224 mg/L CaCO3

Test temperature:

18.7 – 19.6 ºC

pH:

fresh: 7.7 - 7.84
termination: 7.85 - 7.89

Dissolved oxygen:

fresh: 8.5 - 8.9 mg/L
termination: 7.7 - 8.3 mg/L

Salinity:

46 mg/L NaHCO3

Conductivity:

598 µS/cm

Nominal and measured concentrations:

Nominal: 10, 18, 32, 57, and 100 mg/L (loading)

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beakers
- Type: closed
- Material, size, headspace, fill volume: glass ,150 mL, fill volume: 100 mL
- Aeration: No
- Renewal rate of test solution: after 24 h
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
Composition of ISO water: see "Any other information on materials and methods"


OTHER TEST CONDITIONS
- Photoperiod: (light/dark) (h) 16/8

EFFECT PARAMETERS MEASURED: mobility

RANGE-FINDING STUDY
- Test concentrations: 12, 120 mg/L, 10-fold diluted filtrate of a loading of 12 mg/L
- Results used to determine the conditions for the definitive study: At exposure termination in the test item concentration filtrate of a loading of 120 mg/L, the immobilization of Daphnia magna was 100%

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

72.4 mg/L

Nominal / measured:

nominal

Conc. based on:

other: loading rate

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EL10

Effect conc.:

42.8 mg/L

Nominal / measured:

nominal

Conc. based on:

other: loading rate

Basis for effect:

mobility

Effect concentrations 3

Duration:

48 h

Dose descriptor:

LOELR

Effect conc.:

57 mg/L

Nominal / measured:

nominal

Conc. based on:

other: loading rate

Basis for effect:

mobility

Effect concentrations 4

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

32 mg/L

Nominal / measured:

nominal

Conc. based on:

other: loading rate

Basis for effect:

mobility

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- Relevant effect levels: LOEC (48 h) ≤ 0.32 mg/L
- Limit test: No
- Dose-response test: Yes
- EC10: 24 h 0.33 mg/L

Any other information on results incl. tables

Table 2: Immobilisation, definitive test

Test item concentration	Number of Daphnia magna	Number of immobilized Daphnia magna								Total of immobilized Daphniamagna [%]
		24 h				48 h
		Replicates
		A	B	C	D	A	B	C	D	24 h	48 h
Control	20	0	0	0	0	0	0	0	0	0	0
filtrate of a loading of 10 mg/L	20	0	0	0	0	0	0	0	0	0	0
filtrate of a loading of 18 mg/L	20	0	0	0	0	0	0	0	0	0	0
filtrate of a loading of 32 mg/L	20	0	0	0	0	0	0	0	0	0	0
filtrate of a loading of 57 mg/L	20	0	0	1	1	1	1	3	2	10	35
filtrate of a loading of 100 mg/L	20	2	1	0	1	4	4	3	4	20	75

 

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The test substance is acutely harmful for aquatic invertebrates.