Reaction mass of 3H-Indolium, 2-[[2-(4-methoxyphenyl)-2-methylhydrazinylidene]methyl]-1,3,3-trimethyl- and acetate

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

for read across substance

Justification for type of information:

Data for the target chemical is summarized based on the structurally similar read across chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

WoE report is based on two short term toxicity study of invertebrate for the test chemical :1.To evaluate short term toxicity of test material2.Short term toxicity of test material to aquatic invertebrates was performed according to the OECD 202 guideline in a static system.

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material : Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate- Molecular formula : C20H24N3OC2H3O2- Molecular weight : 381.473 g/mol- Smiles notation : [N+]=1(c2ccccc2C(C)(C)C1\C=N\NCc1ccc(cc1)OC)C.C(C)(=O)[O-]- InChl : 1S/C20H23N3O.C2H4O2/c1-20(2)17-7-5-6-8-18(17)23(3)19(20)14-22-21-13-15-9-11-16(24-4)12-10-15;1-2(3)4/h5-12,14H,13H2,1-4H3;1H3,(H,3,4)- Substance type: Organic- Physical state: Liquid (Yellow)

Analytical monitoring:

not specified

Details on sampling:

2.The stock solution 20 mg/L was prepared by dissolving dark violet iquid in reconstituted water. Test solutions of required concentrationas were prepared by mixing the stock solution of the test sample with reconstituted test water.

Vehicle:

not specified

Test organisms (species):

Daphnia magna

Details on test organisms:

2.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 feeding

Test type:

static

Water media type:

freshwater

Total exposure duration:

48 h

Test temperature:

2)20±1°C

pH:

2)Test at 0.100 mg/l: 8.1 (changed to 7.9 during test)Control: 7.7 (Changed to 7.9 during test)

Dissolved oxygen:

2)higher than 8.7 mg/L at the end of test

Nominal and measured concentrations:

2) 0, 0.006, 0.012, 0.025, 0.050, 0.100 mg/l

Details on test conditions:

2.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:

K2Cr2O7

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.27 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.037 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% CL: 0.025-0.054 mg/l

Results with reference substance (positive control):

- Results with reference substance valid- EC50: 0.76 mg/L (24 hours)

Reported statistics and error estimates:

EC50 was calculated using non linear regression by the software Prism 4.0

Conclusions:

The test chemical Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate is likely to be toxic to aquatic invertebrate in the dose range of 0.27 - 0.037 mg/l

Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the short term toxicity of aquatic invertebrate of the test chemical Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate .The studies are as mentioned below:

1.Short term immobilization test of aquatic invertebrate was evaluated using the test chemical. The test chemical was subjected to Daphnia magna under static condition for 48 hr. The effect concentration (EC50) of test material on Daphnia magna was observed to be 0.27 after 48 h.

2.Determination of the inhibition of the mobility of daphnids was carried out with the substance test material according to OECD Guideline 202.

The test substance was tested at the concentrations 0, 0.006, 0.012, 0.025, 0.050, 0.100 mg/l. Effects on immobilisation were observed for 48 hours.

The median effective concentration (EC50) for the test substance, in Daphnia magna was determined to be 0.037 mg/L for immobilisation effects.

This value indicates that the substance is likely to be hazardous to aquatic invertebrates and can be classified as aquatic acute 1 as per the CLP criteria.

Thus, based on the above summarised studies, 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium acetate and it’s structurally similar read across substance, it can be concluded that effect concetration value is greater than 0.27 - 0.037 mg/L. Thus, comparing this value with the criteria of CLP regulation, Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate can be classified for short term toxicity for aquatic invertebrate as "Aquatic chronic 1" .

Description of key information

Short-term toxicity to aquatic invertebrates:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the short term toxicity of fish of the test chemical Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate .The studies are as mentioned below:

1.Short term immobilization test of aquatic invertebrate was evaluated using the test chemical. The test chemical was subjected to Daphnia magna under static condition for 48 hr. The effect concentration (EC50) of test material on Daphnia magna was observed to be 0.27 after 48 h.

2.Determination of the inhibition of the mobility of daphnids was carried out with the substance test material according to OECD Guideline 202.

The test substance was tested at the concentrations 0, 0.006, 0.012, 0.025, 0.050, 0.100 mg/l. Effects on immobilisation were observed for 48 hours.

The median effective concentration (EC50) for the test substance, in Daphnia magna was determined to be 0.037 mg/L for immobilisation effects.

This value indicates that the substance is likely to be hazardous to aquatic invertebrates and can be classified as aquatic acute 1 as per the CLP criteria.

Thus, based on the above summarised studies, Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate and it’s structurally similar read across substance, it can be concluded that effect concetration value is greater than 0.27 - 0.037 mg/L. Thus, comparing this value with the criteria of CLP regulation, Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate can be classified for short term toxicity for aquatic invertebrate as "Aquatic chronic 1" .

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.27 mg/L

Additional information

Short-term toxicity to aquatic invertebrates:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the short term toxicity of fish of the test chemical Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate .The studies are as mentioned below:

1.Short term immobilization test of aquatic invertebrate was evaluated using the test chemical. The test chemical was subjected to Daphnia magna under static condition for 48 hr. The effect concentration (EC50) of test material on Daphnia magna was observed to be 0.27 after 48 h.

2.Determination of the inhibition of the mobility of daphnids was carried out with the substance test material according to OECD Guideline 202.

The test substance was tested at the concentrations 0, 0.006, 0.012, 0.025, 0.050, 0.100 mg/l. Effects on immobilisation were observed for 48 hours.

The median effective concentration (EC50) for the test substance, in Daphnia magna was determined to be 0.037 mg/L for immobilisation effects.

This value indicates that the substance is likely to be hazardous to aquatic invertebrates and can be classified as aquatic acute 1 as per the CLP criteria.

Thus, based on the above summarised studies, Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate and it’s structurally similar read across substance, it can be concluded that effect concetration value is greater than 0.27 - 0.037 mg/L. Thus, comparing this value with the criteria of CLP regulation, Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate can be classified for short term toxicity for aquatic invertebrate as "Aquatic chronic 1" .