Reaction mass of N,N-ethanediylbis- Hexadecanamide, N-[2-[(1-oxohexadecyl)amino]ethyl]-Octadecanamide, Hexadecanoic acid, 12-hydroxystearic acid, reaction products with ethylenediamine, N,N-ethanediylbis-Octadecanamide and Octadecanoic acid, 12-hydroxystearic acid, reaction products with ethylenediamine

Bioaccumulation: aquatic / sediment

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

bioaccumulation in aquatic species, other

Type of information:

calculation (if not (Q)SAR)

Remarks:

Migrated phrase: estimated by calculation

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Accepted calculation method

Qualifier:

no guideline required

Principles of method if other than guideline:

Calculated value using BCFBAF (v3.00) program

GLP compliance:

no

Test organisms (species):

other: calculation for fish

Route of exposure:

aqueous

Test type:

other: calculation

Water / sediment media type:

natural water: freshwater

Type:

BCF

Value:

5.048 dimensionless

Basis:

whole body w.w.

--------------------------------- BCFBAF v3.00 --------------------------------

Summary Results:

Log BCF (regression-based estimate): 0.70 (BCF = 5.05 L/kg wet-wt)

Biotransformation Half-Life (days) : 26.9 (normalized to 10 g fish)

Log BAF (Arnot-Gobas upper trophic): 0.09 (BAF = 1.24 L/kg wet-wt)

 

Log Kow (experimental): not available from database

Log Kow used by BCF estimates: 13.98

 

Equation Used to Make BCF estimate:

Log BCF = -0.49 log Kow + 7.554 + Correction

 

Correction(s): Value

No Applicable Correction Factors

 

Estimated Log BCF = 0.703 (BCF = 5.048 L/kg wet-wt)

 

Reference 2

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 Nov - 24 Dec 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: Circular on the Japanese Test Methods of New Chemical Substances, bioaccumulation test

Deviations:

yes

Remarks:

no control of water and fish and no vehicle control

GLP compliance:

yes

Remarks:

according to the Japanese GLP Standard

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Melting point: 142 ± 2 °C
- Water solubility: < 4.9 μg/L

OTHER PROPERTIES
- Acute toxicity to fish (species, duration, LC50, type and concentration of vehicle if used): LC50 for 48 hours: > 300 mg/L
- Other: solubility: < 200 μg/L in hexane, 57 mg/L in chloroform, < 200 μg/L in ethyl acetate, < 200 μg/L in methanol, < 4.9 mg/L in octanol

Details on sampling:

- Sampling intervals/frequency for test organisms: 2, 3, 4 and 6 weeks after exposure
- Sampling intervals/frequency for test medium samples: twice in a week
- Sample storage conditions before analysis: analysis was conducted immediately after sampling, no storage
- Details on sampling and analysis of test organisms and test media samples (e.g. sample preparation, analytical methods):1) test media: no pre-treatment; 2) Fish samples: measurement of weight and length, added with ethanol and potassium hydroxide, heated to reflux, cooled and filtered with glass wool.

Vehicle:

yes

Details on preparation of test solutions, spiked fish food or sediment:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: After test substance was mixed with crystal sugar and HCO-40, it was dissolved in ion-exchanged water
- Controls: dilution water
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): crystal sugar and HCO-40
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): 3000 mg/L in stock solution;

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Koi
- Source: Sugishimafish farms, Yashiro, Japan
- Age at study initiation (mean and range, SD): not stated
- Length at study initiation (mean): 9.6 cm
- Weight at study initiation (mean): 23.0 g
- Lipid content (mean): 3.9%
- Feeding during test: yes
- Food type: pellet mixed feed
- Amount: 2% of body weight
- Frequency: twice a day

ACCLIMATION
- Acclimation period: 52 days in an acclimation container and 7 days in a test container
- Acclimation conditions (same as test or not): 7 days: same as test
- Type and amount of food: pellet mixed feed, 2% of body weight
- Feeding frequency: twice a day
- Pretreatment: Treatment with Tetramycin (Pfeizer, Tokyo, Japan) and saline for 24 hours under a static condition

Route of exposure:

aqueous

Test type:

flow-through

Water / sediment media type:

natural water: freshwater

Total exposure / uptake duration:

6 wk

Test temperature:

25 ± 2 °C

Dissolved oxygen:

concentration 1 (0.830 mg/L, nominal): 5.7 - 6.6 mg/L
concentration 2 (0.083 mg/L, nominal): 6.2 - 7.0 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 L container
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass,
- Aeration: not stated
- Type of flow-through (e.g. peristaltic or proportional diluter): proportional dilution
- Renewal rate of test solution (frequency/flow rate): 800 mL/min, 1158 L/day
- No. of organisms per vessel: 15
- No. of vessels per concentration (replicates): 1
- No. of vessels per control / vehicle control (replicates): not stated
- Biomass loading rate: no data

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ground water
- Intervals of water quality measurement: once in 6 months

OTHER TEST CONDITIONS
- Adjustment of pH: not stated
- Photoperiod: not stated
- Light intensity: not stated

RANGE-FINDING / PRELIMINARY STUDY
- Results used to determine the conditions for the definitive study: Acute fish (Oryzias latipes) toxicity test was performed, and LC50 for 96 hours was determined as > 300 mg/L (based on a nominal concentration).

Nominal and measured concentrations:

Nominal concentrations:
concentration 1: 0.830 mg/L (substance A: 0,290 mg/L and substance B: 0.826 mg/L)
concentration 2: 0.083 mg/L, (substance A: 0,029 mg/L and substance B: 0.0826 mg/L)

Reference substance (positive control):

no

Details on estimation of bioconcentration:

no data

Lipid content:

3.9 %

Time point:

start of exposure

Type:

BCF

Value:

< 0.7 dimensionless

Basis:

whole body w.w.

Time of plateau:

6 wk

Calculation basis:

steady state

Remarks on result:

other: refers to test substance

Remarks:

Conc.in environment / dose:0.830 mg/L

Type:

BCF

Value:

< 6.2 dimensionless

Basis:

whole body w.w.

Time of plateau:

6 wk

Calculation basis:

steady state

Remarks on result:

other: refers to test substance

Remarks:

Conc.in environment / dose:0.083 mg/L

Details on results:

- Mortality of test organisms: no data
- Behavioural abnormalities: no data
- Observations on body length and weight: determined but no data
- Other biological observations: no data
- Organ specific bioaccumulation: not determined
- Mortality and/or behavioural abnormalities of control: no data
- Loss of test substance during test period: no data
- Results with vehicle control: not performed

Table 1. Measured concentration of test substance

		2 weeks	3 weeks	4 weeks	6 weeks
0.830 mg/L	A	0.245	0.243	0.245	0.247
	B	0.727	0.717	0.722	0.733
	C	0.739	0.733	0.736	0.750
0.0830 mg/L	A	0.0258	0.0258	0.0264	0.0259
	B	0.0785	0.0777	0.0791	0.0773
	C	0.0790	0.0794	0.0807	0.0800

A: stearamide (composition of test material), B: N-ethyl-stearamide (composition of test material), C: 1,2-bis(stearoylamino)ethane (active substance)

Table 2. Result of BCF

		2 weeks	3 weeks	4 weeks	6 weeks
0.830 mg/L	A	> 0.7 > 0.7	> 0.7 > 0.7	> 0.7 > 0.7	> 0.7 > 0.7
	B	> 0.4 > 0.4	> 0.4 > 0.4	> 0.4 > 0.4	> 0.4 > 0.4
	C	> 0.7 > 0.7	> 0.7 > 0.7	> 0.7 > 0.7	> 0.7 > 0.7
0.0830 mg/L	A	> 6.6 > 6.6	> 6.6 > 6.6	> 6.6 > 6.6	> 6.6 > 6.6
	B	> 3.8 > 3.8	> 3.8 > 3.8	> 3.8 > 3.8	> 3.8 > 3.8
	C	> 6.2 > 6.2	> 6.2 > 6.2	> 6.2 > 6.2	> 6.2 > 6.2

Reference 3

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

Refer to chapter 13

Reason / purpose for cross-reference:

read-across source

Lipid content:

3.9 %

Time point:

start of exposure

Type:

BCF

Value:

< 0.7 dimensionless

Basis:

whole body w.w.

Time of plateau:

6 wk

Calculation basis:

steady state

Remarks on result:

other: refers to test substance

Remarks:

Conc.in environment / dose:0.830 mg/L

Type:

BCF

Value:

< 6.2 dimensionless

Basis:

whole body w.w.

Time of plateau:

6 wk

Calculation basis:

steady state

Remarks on result:

other: refers to test substance

Remarks:

Conc.in environment / dose:0.083 mg/L

Validity criteria fulfilled:

yes

Conclusions:

Based on the result of bioconcentration flow-through fish test with the Read Across substance Amides, C16-C18 (even), N,N'-ethylenebis it can be concluded that the registered substance did not exhibit potential for bioconcentration in fish species.

Executive summary:

The potential for bioconcentration of the Read Across substance Amides, C16-C18 (even), N,N'-ethylenebis in a freshwater fish, Cyprinus carpio, was investigated in one study from the Japanese Ministry of International Trade and Industry (MITI, 1988). The study was conducted according to OECD Guideline No. 305: Bioconcentration: Flow-through Fish Test (1996). The fishes were exposed to two concentrations of the test substance (0.830 mg/L and 0.083 mg/L) for a period of 6 weeks, under flow-through water conditions. At the end of the test, estimated BCFs were <0.7 and <6.2 at the 0.830 and 0.083 mg/L concentrations respectively. Therefore, the test substance did not exhibit potential for bioconcentration in fish species.

Description of key information

The potential for bioconcentration of the Read Across substance Amides, C16-C18 (even), N,N'-ethylenebis in a freshwater fish, Cyprinus carpio, was investigated in one study from the Japanese Ministry of International Trade and Industry (MITI, 1988). The study was conducted according to OECD Guideline No. 305: Bioconcentration: Flow-through Fish Test (1996). The fishes were exposed to two concentrations of the test substance (0.830 mg/L and 0.083 mg/L) for a period of 6 weeks, under flow-through water conditions. At the end of the test, estimated BCFs were <0.7 and <6.2 at the 0.830 and 0.083 mg/L concentrations respectively. Therefore, the test substance did not exhibit potential for bioconcentration in fish species.       

 

   

Additional information about this endpoint could be gathered through BCF calculation using BCFBAF (v3.00), a subroutine of theEPI Suite™ computer program. The BCF estimated value, based on whole body wet weight, was 5.048, and thus it supports the experimental result.

 

In conclusion, there is no indication of bioaccumulation potential.

Key value for chemical safety assessment

BCF (aquatic species):

6 dimensionless