N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Experimental test result performed according to the guideline.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Principles of method if other than guideline:

Acute immobilization Study of test material on Daphnia magna in a Static System

GLP compliance:

no

Analytical monitoring:

not specified

Vehicle:

no

Details on test solutions:

Therefore, the stock solution was prepared by dissolving 200 mg of the test substance in 200 ml of ADaMs’ media with continuous 72 hrs stirring and the concentration of stock solution was analytically detected and then the test solution was prepared for achieving the test concentrations of 6.25 mg/L, 12.5 mg/L, 25 mg/L, 50 mg/L & 100 mg/L, respectively.

Test organisms (species):

Daphnia magna

Details on test organisms:

- Common name: Water flea
- Source: Own breeding of daphnia magna
- Food: No feeding after hatching

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

24 and 48 hrs

Hardness:

200 mg of CaCO3

Test temperature:

20±2

pH:

7.8

Nominal and measured concentrations:

6.25 mg/L, 12.5 mg/L, 25 mg/L, 50 mg/L & 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beaker
- Aeration: No aeration during experiment
- Material, size, headspace, fill volume: 25 ml of glass beaker filled with 20 ml media having headspace of 5 ml
- No. of organisms per vessel: 10 daphnids

OTHER TEST CONDITIONS
- Photoperiod:16 hours light and 8 hours dark

Reference substance (positive control):

not specified

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 50 - < 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: EC50 (48 hours) Experimental > 50 mg/L but < 100 mg/L

9.1. Immobility

Nominal	Number	of	Immobility
Concentration	Daphnids	0 h	24 h	48 h
(mg/l)
Control	10	-	-	-
6.25	10	-	-	-
12.5	10	-	-	-
25	10	-	-	-
50	10	-	-	-
100	10	-	4	3

9.2. pH and oxygen content:

Nominal	Number of	pH(mg/L)
Concentration	daphnids	0h	48h
(mg/l)
Control	10	7.8	7.6	7.0
6.25	10	7.7	7.6	7.1
12.5	10	7.8	7.6	7.4
25	10	7.7	7.4	7.4
50	10	7.7	7.2	7.3
100	10	7.6	7.6	7.3

Nominal	Number of	DO(mg/L)
Concentration	daphnids	0h	48h
(mg/l)
Control	10	7.4	6.3	6.3
6.25	10	6.9	6.0	6.0
12.5	10	6.9	6.1	6.1
25	10	6.7	5.9	5.9
50	10	6.7	5.7	5.7
100	10	6.5	5.1	5.1

9.3. Test temperature

Nominal	Number of	Temparature
Concentration	daphnids	0h	48h
(mg/l)
Control	10	21.5		21.6
6.25	10	21.4		21.7
12.5	10	21.4		21.7
25	10	21.4		21.5
50	10	21.4		21.5
100	10	21.4		21.5

Validity criteria fulfilled:

yes

Remarks:

1. In the control, including the control containing the solubilising agent, not more that 10 percent of the daphnids should have been immobilized. 2. The dissolved oxygen concentration at the end of the test should be 3 mg/l in control and test vessels

Conclusions:

Based on nominal concentrations, experimental median effective Concentrations [EC-50 (48 h)] for test material on test daphnia was found to be > 50 mg/L but < 100 mg/L

Executive summary:

Daphnia sp., Acute Immobilization Test according to OECD Guideline 203 was conducted for disodium butanedioate. Therefore, the stock solution was prepared by dissolving 200 mg of the test substance in 200 ml of ADaMs’ media with continuous 72 hrs stirring and the concentration of stock solution was analytically detected and then the test solution was prepared for achieving the test concentrations of 6.25 mg/L, 12.5 mg/L, 25 mg/L, 50 mg/L & 100 mg/L, respectively.

The median lethal concentration (EC50) for test material on Daphnia magna in a 48 hours study on the basis of immobilization effect was found to be > 50 mg/L but < 100 mg/L. Thus, on the basis of this EC50 value and according to CLP criteria for aquatic classification of the substance, it is concluded that exhibits short term toxicity to Daphnia.

After 48 hours of exposure to test item to various nominal test concentrations, EC50 was determine to be > 50 mg/L but < 100 mg/L. Based on the EC50, it can be consider that the chemical was toxic and can be consider to be classified aq aquatic chronic 3 as per the CLP classification criteria.

Description of key information

Short term toxicity to aquatic invertebrate:

Daphnia sp., Acute Immobilization Test according to OECD Guideline 203 was conducted for disodium butanedioate. Therefore, the stock solution was prepared by dissolving 200 mg of the test substance in 200 ml of ADaMs’ media with continuous 72 hrs stirring and the concentration of stock solution was analytically detected and then the test solution was prepared for achieving the test concentrations of 6.25 mg/L, 12.5 mg/L, 25 mg/L, 50 mg/L & 100 mg/L, respectively.

The median lethal concentration (EC50) for test material on Daphnia magna in a 48 hours study on the basis of immobilization effect was found to be > 50 mg/L but < 100 mg/L. Thus, on the basis of this EC50 value and according to CLP criteria to aquatic uatic classification of the substance, it is concluded that exhibits short term toxicity to Daphnia.

After 48 hours of exposure to test item to various nominal test concentrations, EC50 was determine to be> 50 mg/L but < 100 mg/L. Based on the EC50, it can be consider that the chemical was toxic and can be consider to be classified aq aquatic chronic 3 as per the CLP classification criteria.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

50 mg/L

Additional information

Short term toxicity to aquatic invertebrate:

Daphnia sp., Acute Immobilization Test according to OECD Guideline 203 was conducted for disodium butanedioate. Therefore, the stock solution was prepared by dissolving 200 mg of the test substance in 200 ml of ADaMs’ media with continuous 72 hrs stirring and the concentration of stock solution was analytically detected and then the test solution was prepared for achieving the test concentrations of 6.25 mg/L, 12.5 mg/L, 25 mg/L, 50 mg/L & 100 mg/L, respectively.

The median lethal concentration (EC50) for test material on Daphnia magna in a 48 hours study on the basis of immobilization effect was found to be > 50 mg/L but < 100 mg/L. Thus, on the basis of this EC50 value and according to CLP criteria for aquatic classification of the substance, it is concluded that exhibits short term toxicity to Daphnia.

After 48 hours of exposure to test item to various nominal test concentrations, EC50 was determine to be> 50 mg/L but < 100 mg/L. Based on the EC50, it can be consider that the chemical was toxic and can be consider to be classified aq aquatic chronic 3 as per the CLP classification criteria.