Aluminium, 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid complex

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06-09-2016 to 08-09-2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Experimental test result performed using standard test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Principles of method if other than guideline:

Short term toxicity of test chemical to aquatic invertebrates was performed according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) in a static system.

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material (as cited in study report): C.I. Food Blue 1- Molecular formula (if other than submission substance): C16H8N2S2O8Na2- Molecular weight (if other than submission substance): 449.375 g /mol- Substance type: Organic- Physical state: Dark-blue powder or granules- Smiles notation (if other than submission substance): C1(=C2\C(c3cc(S(O)(=O)=O)ccc3N2)=O)\C(c2cc(S(O)(=O)=O)ccc2N1)=O.[Al+3]

Analytical monitoring:

not specified

Vehicle:

yes

Details on test solutions:

The solution 100 mg/l was prepared by dissolving blue powder in OECD growth medium. The solution was kept 5 min in ultrasonic bath.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM- Common name: Water flea- Strain: Straus- Source: Own breeding at University of Chemistry and Technology, Prague- Age at study initiation (mean and range, SD): The animals used for the test shall be less than 24 h old and should not be first brood progeny- Feeding during test: No feedingACCLIMATION - No data available- Acclimation period:- Acclimation conditions (same as test or not):- Type and amount of food:- Feeding frequency:- Health during acclimation (any mortality observed):

Test type:

static

Water media type:

freshwater

Total exposure duration:

72 h

Remarks on exposure duration:

± 1 hr

Test temperature:

20±1°C

pH:

Sample: 7.5 changes to 7.8 during test Control: 7.8 changes to 7.7 during test

Dissolved oxygen:

higher than 7.7 mg/L at the end of test

Nominal and measured concentrations:

Limit test performed at 100 mg/l

Details on test conditions:

TEST SYSTEM- Test vessel: 50 ml glass vessel- fill volume: 25 ml- No. of organisms per vessel: 5- No. of vessels per concentration (replicates): 4TEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: Natural water (surface or ground water), reconstituted water or dechlorinated tap water are acceptable as culturing and dilution water if D. magna survives in it for the duration of the culturing, acclimation and testing without showing signs of stress. Waters in the range pH 6 to pH 9, with hardness between 140 mg/l and 275 mg/l (as CaCO3) are recommended.As an example, the preparation of dilution water meeting the requirements is described below.Dissolve known quantities of reagents in water. The dilution water prepared shall have a pH of 7.8 ± 0.5, a hardness of (225 ± 50) mg/l (expressed as CaCO3), a molar Ca + Mg ratio close to 4 + 1 and a dissolved oxygen concentration above 7 mg/l.Prepare the solutions specified below:- Calcium chloride solution: Dissolve 117.6 g of calcium chloride dihydrate (CaCl2.2H2O) in water (4.2) and make up to 1 l with water (4.2).- Magnesium sulfate solution: Dissolve 49.3 g of magnesium sulfate heptahydrate (MgSO4.7H2O) in water (4.2) and make up to 1 l with water (4.2).- Sodium bicarbonate solution: Dissolve 25.9 g of sodium bicarbonate (NaHCO3) in water (4.2) and make up to 1 l with water (4.2).- Potassium chloride solution: Dissolve 2.3 g of potassium chloride (KCI) in water (4.2) and make up to 1 l with water (4.2).MixingMix 2.5 ml of each of the four solutions and make up to 1 l with water.The dilution water shall be aerated until the dissolved oxygen concentration has reached saturation and the pH has stabilized. If necessary, adjust the pH to 7.8 ± 0.5 by adding sodium hydroxide (NaOH) solution or hydrochloric acid (HCI). The dilution water prepared in this way shall not be further aerated before use.- Sodium hydroxide solution, e.g. [NaOH] : 1 mol/l.- Hydrochloric acid, e.g. [HCl] : 1 mol/l.Reference substance: Dissolve 600 mg of potassium dichromate (K2Cr2O7) in water and make up to 1 l with water (4.2).OTHER TEST CONDITIONS- Adjustment of pH: no adjustment done- Photoperiod: No - Darkness- Light intensity:CALCULATION:EC50 was calculated using non linear regression by the software Prism 4.0

Reference substance (positive control):

yes

Remarks:

Potassium dichromate (K2Cr2O7)

Key result

Duration:

72 h

Dose descriptor:

other: IC

Effect conc.:

100 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 8% inhibition were observed

Results with reference substance (positive control):

- Results with reference substance valid- EC50: 0.79 mg/L (24 hours)

Validity criteria fulfilled:

yes

Conclusions:

After the incubation period of 48 hrs in which daphnids exposed with test chemical C.I. Food Blue 1, only 8 % inhibition were observed at 100 mg/l. Thus on the basis of only 8 % inhibition it was consider that the IC50 was > 100 mg/l and the chemical was nontoxic.

Executive summary:

Aim of this study was to access the short term toxicity of test chemical C.I. Food Blue 1 to aquatic invertebrates daphnia magna. Study was performed according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) in a static system for the total exposure period of 48 hrs.

 

The solution 100 mg/l was prepared by dissolving blue powder in OECD growth medium. The solution was kept 5 min in ultrasonic bath. Limit test at 100 mg/l were performed. Effects on immobilisation were observed for 48 hours. With the test substance one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. After the exposure of chemical, effect concentration EC50 was calculated using nonlinear regression by the software Prism 4.0.

 

After the incubation period of 48 hrs in which daphnids exposed with test chemical C.I. Food Blue 1, only 8 % inhibition were observed at 100 mg/l. Thus on the basis of only 8 % inhibition it was consider that the IC50 was > 100 mg/l and the chemical was nontoxic and non-hazardous to aquatic invertebrates and cannot be classified as per the CLP criteria.

Description of key information

Aim of this study was to access the short term toxicity of test chemical C.I. Food Blue 1 to aquatic invertebrates daphnia magna. Study was performed according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) in a static system for the total exposure period of 48 hrs. The solution 100 mg/l was prepared by dissolving blue powder in OECD growth medium. The solution was kept 5 min in ultrasonic bath. Limit test at 100 mg/l were performed. Effects on immobilisation were observed for 48 hours. With the test substance one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. After the exposure of chemical, effect concentration EC50 was calculated using nonlinear regression by the software Prism 4.0. After the incubation period of 48 hrs in which daphnids exposed with test chemical C.I. Food Blue 1, only 8 % inhibition were observed at 100 mg/l. Thus on the basis of only 8 % inhibition it was consider that the IC50 was > 100 mg/l and the chemical was nontoxic and non-hazardous to aquatic invertebrates and cannot be classified as per the CLP criteria.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

Summarized result for the toxicity of test chemical (Cas no. 16521 -38 -3) on the growth of aquatic invertebrates are as follows:

In the first key study from experimental report toxicity was measured. Aim of this study was to access the short term toxicity of test chemical C.I. Food Blue 1 to aquatic invertebrates daphnia magna. Study was performed according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) in a static system for the total exposure period of 48 hrs. The solution 100 mg/l was prepared by dissolving blue powder in OECD growth medium. The solution was kept 5 min in ultrasonic bath. Limit test at 100 mg/l were performed. Effects on immobilisation were observed for 48 hours. With the test substance one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. After the exposure of chemical, effect concentration EC50 was calculated using nonlinear regression by the software Prism 4.0. After the incubation period of 48 hrs in which daphnids exposed with test chemical C.I. Food Blue 1, only 8 % inhibition were observed at 100 mg/l. Thus on the basis of only 8 % inhibition it was consider that the IC50 was > 100 mg/l and the chemical was nontoxic and non-hazardous to aquatic invertebrates and cannot be classified as per the CLP criteria.

Similarly in the second supporting study from peer reviewed journal, acute toxicity study for test chemical in Daphnia similis when they were exposed for 48 hr. 20 % immobilization was observed at test concentrations of 30mg/l. Test conducted under the static system. Daphnia fed during the test on algae Ankistrodesmus falcatus. After the exposure of test chemical for 48 hrs, EC20 were observed at 30 mg/l on the basis of immobility of daphnia similis. Thus on that basis chemical was not consider as toxic and not classified as per the CLP classification criteria.

Based on the above experimental studies, it was concluded that the test chemical was nontoxic and not classified as per the CLP classification criteria.