Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study according to 84/449/EEC and GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

Directive 84/449/EEC

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances):

A stock solution was prepared by intensive stirring of the test item (0.2 %) in DMF puriss. Fluka (0.02 %). Different test concentrations were prepared by dilution with deionized water.

The following concentrations were tested: 100 mg/L - 1000 mg/L test item, containing 10 mg/L - 100 mg/L DMF

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Strain: Daphnia magna STRAUS
- Source: Federal Office of Health , Berlin, Germany; Breeder: Dr. U. Noack-Laboratorien, Sarstedt, Germany
- Method of breeding:
Culture: In 2 L glass vessels at 20 ± 2 °C; vessels ventilated; water change 3 times per week
Culture medium: dilution water according to DIN 38412, part II, 8.2

ACCLIMATION
- Acclimation period: at least 2 h in dilution water
- Type and amount of food: dry food
- Feeding frequency: 2 times per day

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

none

Test temperature:

21.3 °C constant

pH:

7.29-7.85 (test solutions), 7.42 (control dilution water); 7.71 and 7.76 (control 58 mg/L and 100 mg/L DMF)

Dissolved oxygen:

8.2 - 8.5 (test solutions), 8.5 (control dilution water); 8.4 (control 58 mg/L and 100 mg/L DMF)

Nominal and measured concentrations:

Nominal concentrations: 100, 180, 320, 580 and 1000 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers 50 mL, DIN 12 331; 20 mL test solutions
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: deionized water (conductivity < 5 µS/cm

OTHER TEST CONDITIONS
- Photoperiod: 12/12 h light/dark cycle
- Light intensity: diffuse light, ca. 10 [µE/m2 x s]

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobilisation at 24 and 48 h

TEST CONCENTRATIONS
- Test concentrations: see above

Reference substance (positive control):

yes

Remarks:

potassium dichromate p.a. (Merck)

Duration:

24 h

Dose descriptor:

EC0

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

750 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

precipitation of the test substance was observed in all test concentrations approximately 3 h after preparation of the test solution

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- Mortality:
- EC0: 0.7 mg/L
- EC50: 1.2 mg/L
- EC100: 2.0 mg/L

Test concentrations for EC-determination

Test item [mg/L]	DMF [mg/L]	Immobilisation 24 h [%]		Immobilisation 48 h [%]
		Replicate 1	Replicate 2	Replicate 1	Replicate 2
100	10	0	0	10	0
180	18	10	0	10	20
320	32	10	10	10	20
580	58	20	10	30	20
1000	100	50	50	50	60
Control dilution water	0	0	0	0	0
control 58 mg/L DMF	0	0	0	0	0
control 100 mg/L DMF	0	0	0	0	0

Validity criteria fulfilled:

yes

Conclusions:

EC50 (48 h) = 750 mg/L (nominal). Therefore, the substance has not to be classified for acute aquatic toxicity according to Regulation (EC) No 1272/2008

Executive summary:

In the acute immobilisation test with Daphnia magna (STRAUS) the effect of different test concentrations of Pigment Yellow 191, was determined according to Directive 84/449/EEC. The test was conducted under static conditions over 48 h. 2 replicates with 10 test organisms respectively were exposed to test concentrations of 100, 180, 320, 580 and 1000 mg/L (nominal) and the control. DMF was used as solvent. A reference test was carried out with potassium dichromate to determine the toxicity of the reference item. The EC50-value of the reference item of 1.2 mg/L after 24 h was within the prescribed concentration range of 1.0 to 2.5 mg/L according to AQS. Water quality parameters pH-value and dissolved oxygen concentration, measured at 0 and 48 h, were determined to be within the acceptable limits. The validity criteria of the test guideline were fulfilled.

Since the solubilty of the substance is far below the EC 50 value, the result ist treated as not reliable.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reason / purpose for cross-reference:

read-across source

Duration:

24 h

Dose descriptor:

EC0

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

750 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

precipitation of the test substance was observed in all test concentrations approximately 3 h after preparation of the test solution

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- Mortality:
- EC0: 0.7 mg/L
- EC50: 1.2 mg/L
- EC100: 2.0 mg/L

Test concentrations for EC-determination

Test item [mg/L]	DMF [mg/L]	Immobilisation 24 h [%]		Immobilisation 48 h [%]
		Replicate 1	Replicate 2	Replicate 1	Replicate 2
100	10	0	0	10	0
180	18	10	0	10	20
320	32	10	10	10	20
580	58	20	10	30	20
1000	100	50	50	50	60
Control dilution water	0	0	0	0	0
control 58 mg/L DMF	0	0	0	0	0
control 100 mg/L DMF	0	0	0	0	0

Validity criteria fulfilled:

yes

Conclusions:

EC50 (48 h) = 750 mg/L (nominal). Therefore, the substance has not to be classified for acute aquatic toxicity according to Regulation (EC) No 1272/2008

Executive summary:

In the acute immobilisation test with Daphnia magna (STRAUS) the effect of different test concentrations of Pigment Yellow 191, was determined according to Directive 84/449/EEC. The test was conducted under static conditions over 48 h. 2 replicates with 10 test organisms respectively were exposed to test concentrations of 100, 180, 320, 580 and 1000 mg/L (nominal) and the control. DMF was used as solvent. A reference test was carried out with potassium dichromate to determine the toxicity of the reference item. The EC50-value of the reference item of 1.2 mg/L after 24 h was within the prescribed concentration range of 1.0 to 2.5 mg/L according to AQS. Water quality parameters pH-value and dissolved oxygen concentration, measured at 0 and 48 h, were determined to be within the acceptable limits. The validity criteria of the test guideline were fulfilled.

Since the solubilty of the substance is far below the EC 50 value, the result ist treated as not reliable.

Description of key information

In the acute immobilisation test with Daphnia the effect of different test concentrations of Pigment Yellow 191, was determined according to Directive 84/449/EEC.  The test was conducted under static conditions with to test concentrations of 100, 180, 320, 580 and 1000 mg/L (nominal) and the control. DMF was used as solvent. 
EC50 (48 h) = 750 mg/L    

Additional information

Since the solubilty of the substance is far below the EC 50 value, the result ist treated as not reliable.