N-[3-(dimethylamino)propyl]dodecanamide

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

key study

Study period:

2009-03-17 to 2009-03-19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl]

EC Number:

930-947-3

IUPAC Name:

Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl]

Details on test material:

- Name of the test material (as cited in study report): Tego-Amid CNF
- Chemical name: Amides, C6-C18, N-[3-(dimethylamino)propyl], Coconutfattyacidamidoamine
- Origin of the test item: Evonik Goldschmidt, Essen
- Analytical Purity: 91.2%
- Lot/Batch Number: UB3236
- Vapour presure: no data
- State of matter and appearence: Pasty, yellow
- Relative density: 0.9077 g/cm3
- Storage conditions: LK12, cool and dry
- Expiry date: 31.05.2010
- Water solubility: 4 g/L
- Impurities: glycole 8.8%

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: were determined in fresh and aged (48h) media
- Sampling method: 1.5 mL of fresh and aged (pooled) samples were transferred into vials of autosampler of LC/MS, aliquots of 20 µL were analyzed
- Sample storage conditions before analysis: ca. 4°C until measurement

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

- Source: Laboratory of the Fraunhofer IME
- Age at study initiation (mean and range, SD): 4-24 h

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

Tot. hardness=1.0 mmol/L; Ca-hardness=0.7 mmol/L

Test temperature:

20.2°C during the first 24h, 20.4°C- next 24h

pH:

8.1-8.4

Dissolved oxygen:

test inition: 8.0 – 8.8 mg/l
test end: 8.4 – 8.9 mg/l

Nominal and measured concentrations:

nominal concentrations (µg/L): control; 125; 250; 500; 1000; 2000
measured concentrations (µg/L)(0 h): < LOQ; 116.9; 242.8; 535.6; 969.2; 1834.6
measured concentrations (µg/L) (48 h): < LOQ; < LOQ; < LOQ; < LOQ; 67.6; 1560.1
LOQ (Limit of quantification) = 47.7 µg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beakers of 50 mL
- Type: covered with glass panes
- Material, size, headspace, fill volume: glass beakers of 50 mL
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): no
- Renewal rate of test solution (frequency/flow rate): no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): no
- Biomass loading rate: no data


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: purified drinking water
- Total organic carbon: 0 mg/L
- Particulate matter: no
- Metals: Fe (3.5-6.9 µg/L), Mn <1.6 (µg/L), Ni <2.5 (µg/L), Pb <1.3 (µg/L), Zn (2.9-9.2) µg/L, Cd <0.63 (µg/L), Cr <2.0 (µg/L)
- Pesticides: no data
- Chlorine: no data
- Alkalinity: 2.0-2.2
- Ca/mg ratio: 2.3(3)
- Conductivity: 261.2-273.7 (µS/cm)
- Culture medium different from test medium: no data
- Intervals of water quality measurement: pH, oxygen saturation and temperature - 48 h


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16/8 h light/dark cycle
- Light intensity: 407-426 Lux

Reference substance (positive control):

not specified

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

94.3 µg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

164.4 µg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

157.2 µg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

Nominal concentrations (µg/L): control; 125; 250; 500; 1000; 2000
Measured concentrations (µg/L)(0 h): < LOQ; 116.9; 242.8; 535.6; 969.2; 1834.6
Measured concentrations (µg/L) (48 h): < LOQ; < LOQ; < LOQ; < LOQ; 67.6; 1560.1

Analyses of fresh and aged exposure media revealed significant decrease of the test item within the 2-day interval. Thus, the (no) effect concentrations were based on mean measured test item concentrations. Due to the decrease of the exposure concentrations, time weighted average co centrations were calculated. For concentrations below the LOQ, a value half of the LOQ was set.
LOQ (Limit of quantification) = 47.7 µg/L.

Neither any signs of disease nor stress like discoloration or abnormal behavior in mobile specimens were observed in any replicate up to a concentration of 1693.6 µg Tego® Amid CNF per liter (TWM). All surviving specimens gave the impression of healthy condition.

- Mortality of control: < 10 %; dissolved oxygen concentration: >= 3 mg/L

Reported statistics and error estimates:

Calculation of EC50 by means of Probit analysis. All statistical calculations were performed using the computer programme ToxRat.

Any other information on results incl. tables

Effect of Tego® Amid CNF on immobilisation of Daphnia magna

 

Nominal concentration µg/L	Observation period
	24 h		48 h
	Mobile daphnids, No.	Immobilisation, %	Mobile daphnids, No.	Immobilisation, %
Control	20	0	20	0
58.5	20	0	20	0
94.3	20	0	20	0
164.4	20	0	7	65
338.7	13	35	0	100
1693.6	0	100	0	100

Concentrations given as TWM (time weighed mean).

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

Mortality in controls did not exceed 10 %, dissolved oxygen concentration after 24 h was > 3 mg/L in control and test vessels.

Conclusions:

In an Acute Immobilisation Test on Daphnia according to OECD 202 an EC50 (48 h) of 157.2 µg/L based on time weighed mean concentrations was determined. The NOEC (48 h) was 94.3 µg Tego-Amid CNF per liter time weighted mean (TWM).

Executive summary:

In an Acute Immobilization Test on Daphnia according to OECD guideline 202, 13 April 2004 and EC method C2, 1992, the influence of Tego-Amid CNF on immobilization of Daphnia magna was investigated. The daphnids were placed in water containing the test item in nominal concentrations of 125, 250, 500, 1000 and 2000 µg/L. The test was conducted under static conditions. Effects on immobilization were determined after 24 and 48 hours. Immobilization was significantly increased starting at a time weighted mean (TWM) concentration of 164.4 µg Tego-Amid CNF per liter (NOEC=94.3 µg/L). The EC50 for the tested species was determined to be 157.2 µg/L basedon time weighed mean concentrations (TWM).

This study is classified as reliable without restriction and satisfies the guideline requirements for an acute toxicity study with invertebrates.

Results Synopsis

Test organism Age: > 4 h and 24 h

Test Type: static

EC50: 157.2 µg/L

NOEC (48 h): 94.3µg/L

LOEC (48 h): 164.4µg/L

Endpoint(s) Effected: immobilisation