Reaction mass of 3H-Indolium, 2-[2-[4-[(2-cyanoethyl)methylamino]phenyl]ethenyl]-1,3,3-trimethyl- & 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:

Experimental result of of 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 mention below

Principles of method if other than guideline:

WoE report is based on two short term toxicity study of invertebrates for the test chemical :1. and 2. To evalute algal growth inhibition test of test material

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-(dimethylamino)phenyl]ethenyl]-1,3,3-trimethyl- & acetate- Molecular formula : C23H28N2O2- Molecular weight : 364.486 g/mol- Smiles notation : [N+]=1(c2ccccc2C(C)(C)C1\C=C\c1ccc(cc1)N(C)C)C.C(C)(=O)[O-]- InChl : 1S/C21H25N2.C2H4O2/c1-21(2)18-8-6-7-9-19(18)23(5)20(21)15-12-16-10-13-17(14-11-16)22(3)4;1-2(3)4/h6-15H,1-5H3;1H3,(H,3,4)/q+1;/p-1- Substance type: Organic- Physical state: Liquid

Analytical monitoring:

not specified

Vehicle:

yes

Details on test solutions:

1. 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.

Test organisms (species):

Daphnia magna

Details on test organisms:

1. 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 feeding2. Age at study initiation: For the test selection of young daphnia with an age of < 24 hours.

Test type:

static

Water media type:

freshwater

Total exposure duration:

48 h

Remarks on exposure duration:

± 1 hr

Post exposure observation period:

2. observations werre made at 24 and 48 h

Test temperature:

1. 20±1°C2. 19.8 to 20.0 °C

pH:

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

Dissolved oxygen:

higher than 8.7 mg/L at the end of test

Nominal and measured concentrations:

1. 0, 0.006, 0.012, 0.025, 0.050, 0.100 mg/l2. 0.1, 1.0, 10 and 100 mg/l

Details on test conditions:

1.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 - Darkness2.10 Daphnia per vessel containing 80 ml test solution

Reference substance (positive control):

yes

Remarks:

Potassium dichromate (K2Cr2O7)

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.037 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: study 1: 95 % CI was 0.025-0.054 mg/l

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: for 2 study value is less than 0.1 mg/l

Results with reference substance (positive control):

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

Reported statistics and error estimates:

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

Study 2:

Incidence of immobility in the screening test with test chemical:

concentration	No. of vessel	No. of Daphnia exposed	Response at 24 h		Response at 48 h
			Number	%	Number	%
0	A B	10 10	0 0	0 0	0 0	0 0
0.1	A B	10 10	10 8	100 80	10 10	100 100
1.0	A B	10 10	10 10	100 100	10 10	100 100
10	A B	10 10	10 10	100 100	10 10	100 100
100	A B	10 10	10 10	100 100	10 10	100 100

Validity criteria fulfilled:

not specified

Conclusions:

1. The median effective concentration (EC50) for the test substance, in Daphnia magna was determined to be 0.037 mg/L on the basis of mobiity inhibition effects in a 48 hour study. 2. Based on the mobility of test organism daphnia magna by providing the exposure period of 48 hrs, the EC50 was determine to be < 0.1 Based on both studies it was concluded that the reaction mass of 3H-​Indolium, 2-​[2-​[4-​(dimethylamino)​phenyl]​ethenyl]​-​1,​3,​3-​trimethyl-​ & acetate was concluded as toxic and classified as aquatic acute 1 and chronic 1 as per the CLP criteria.

Executive summary:

Data available for the structurally and functional similar read across chemicals has been reviewed to determine the toxicity of the test Reaction mass of 3H-​Indolium, 2-​[2-​[4-​(dimethylamino)​phenyl]​ethenyl]​-​1,​3,​3-​trimethyl-​ & acetate on the growth of aquatic invertebrates. The studies are as mentioned below:

 

In the first study from experimental report determination of the inhibition of the mobility of daphnids was carried out with the substance according to OECD Guideline 202.The stock solution 20 mg/L was prepared by dissolving dark violet liquid in reconstituted water. Test solutions of required concentration as were prepared by mixing the stock solution of the test sample with reconstituted test water. 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 / chronic 1 as per the CLP criteria.

 

Similarly the second study was conducted to evaluate the influence of test chemical on the mobility of Daphnia magna. Under the conditions of the study test chemical did induce acute immobilisation of Daphnia magna in all the nominal concentrations tested i.e 0.1, 1.0, 10 and 100 mg/l within 24 hours of exposure. Therefore, the 48h-EC50 value was determine to be <0.1 mg /l. And the chemical was concluded as toxic and classified as aquatic chronic 1.

 

Based on both studies it was concluded that the Reaction mass of 3H-​Indolium, 2-​[2-​[4-​(dimethylamino)​phenyl]​ethenyl]​-​1,​3,​3-​trimethyl-​ & acetate was concluded as toxic and classified as aquatic acute 1 and chronic 1 as per the CLP criteria.

Description of key information

1. The median effective concentration (EC50) for the test substance, in Daphnia magna was determined to be 0.037 mg/L on the basis of mobiity inhibition effects in a 48 hour study.

2. Based on the mobility of test organism daphnia magna by providing the exposure period of 48 hrs, the EC50 was determine to be < 0.1

Based on both studies it was concluded that the chemical reaction mass of 3H-​Indolium, 2-​[2-​[4-​(dimethylamino)​phenyl]​ethenyl]​-​1,​3,​3-​trimethyl-​ & acetate was concluded as toxic and classified as aquatic acute 1 and chronic 1 as per the CLP criteria.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.037 mg/L

Additional information

Data available for the structurally and functional similar read across chemicals has been reviewed to determine the toxicity of the test Reaction mass of 3H-​Indolium, 2-​[2-​[4-​(dimethylamino)​phenyl]​ethenyl]​-​1,​3,​3-​trimethyl-​ & acetate on the growth of aquatic invertebrates. The studies are as mentioned below:

 

In the first study from experimental report determination of the inhibition of the mobility of daphnids was carried out with the substance according to OECD Guideline 202.The stock solution 20 mg/L was prepared by dissolving dark violet liquid in reconstituted water. Test solutions of required concentration as were prepared by mixing the stock solution of the test sample with reconstituted test water. 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 / chronic 1 as per the CLP criteria.

 

Similarly the second study was conducted to evaluate the influence of test chemical on the mobility of Daphnia magna. Under the conditions of the study test chemical did induce acute immobilisation of Daphnia magna in all the nominal concentrations tested i.e 0.1, 1.0, 10 and 100 mg/l within 24 hours of exposure. Therefore, the 48h-EC50 value was determine to be <0.1 mg /l. And the chemical was concluded as toxic and classified as aquatic chronic 1.

 

Based on both studies it was concluded that the Reaction mass of 3H-​Indolium, 2-​[2-​[4-​(dimethylamino)​phenyl]​ethenyl]​-​1,​3,​3-​trimethyl-​ & acetate was concluded as toxic and classified as aquatic acute 1 and chronic 1 as per the CLP criteria.