Reaction mass of N-[3-(dimethylamino)propyl]docosanamide and N-[3-(dimethylamino)propyl]stearamide

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01/2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of glycerol and N-[3-(dimethylamino)propyl]stearamide and N-[3-(dimethylamino)propyl]docosanamide

Molecular formula:

C21 H50 N O C23 H54 N O C25 H58 N O C27 H62 N O

IUPAC Name:

Reaction mass of glycerol and N-[3-(dimethylamino)propyl]stearamide and N-[3-(dimethylamino)propyl]docosanamide

Test material form:

solid: flakes

Sampling and analysis

Analytical monitoring:

not specified

Test solutions

Vehicle:

yes

Test organisms

Test organisms (species):

Anabaena sp.

Study design

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

72 h

Test conditions

Details on test conditions:

pH range : 8.2 ± 1.5
Incubation Temperature : 21–24°C controlled at  2 °C
Initial Biomass concentration weight : 104 cells per ml or 0.5 mg/l
Illumination : 2960- 4440 lux
Growth medium : BG-11 Medium
Apparatus to determine algal biomass : UV-Vis Spectrophotometer
No. of replicates : Five in control and three in test groups

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

72 h

Dose descriptor:

EC10

Effect conc.:

>= 100 mg/L

Conc. based on:

test mat.

Basis for effect:

biomass

Effect concentrations 2

Duration:

72 h

Dose descriptor:

EC20

Effect conc.:

>= 100 mg/L

Conc. based on:

test mat.

Basis for effect:

biomass

Effect concentrations 3

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

>= 100 mg/L

Conc. based on:

test mat.

Basis for effect:

biomass

Effect concentrations 4

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Conc. based on:

test mat.

Basis for effect:

biomass

Details on results:

Since no growth inhibitions were found in the range finding study, thus the limit test
was conducted at the maximum allowable concentration of 100 mg/l of ‘Brassicamidopropyl
Dimethylamine’ in BG-11 medium. The pH measurement in control and ‘Brassicamidopropyl
Dimethylamine’ concentrations are presented in Table 2. Initial pH of BG-11 medium were
in the range of 8.22 – 8.32 and the final pH were recorded in the range of 6.75-6.78 at the
test termination. The test conditions (Temperature and Light intensity of the experimental
room) during the test period are presented in Table 3. During the test, the temperature was
maintained at the range of 23.6-24.1°C and the light intensity was maintained within the
range of 4252 to 4265 lux.
The algae absorbances (optical density) in control and test item concentrations of
‘Brassicamidopropyl Dimethylamine’ are given in Table 4.
Percent growth inhibition of yield and specific growth rate based on control at 0-72
hours of ‘Anabaena sp.’ exposed to various concentrations of ‘Brassicamidopropyl
Dimethylamine’ are given in Table 5.
The maximum concentration of the test item ‘Brassicamidopropyl Dimethylamine’
did not elicit any inhibitory effects on the yield and specific growth rate of algal strain
‘Anabaena sp.’. Therefore, the effective concentrations (ECs) and no observed effect
concentration (NOEC) came out as:
EC10  100 mg/ l
EC20  100 mg/ l
EC50  100 mg/ l
NOEC  100 mg/ l
The percentage inhibition and specific growth rate are calculated by comparing with
the solvent control. The percent coefficient of variation (% CV) at different time interval in
the replicate control flasks was calculated as 18.87% which is less than 35%. Hence, the
result of study complies with the requirements of the OECD Guideline.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Under the condition of this test, it was concluded that maximum concentration of the test
item ‘Brassicamidopropyl Dimethylamine’ i.e. 100 mg/l elicited no inhibitory effects on the
yield and specific growth rate of algal strain ‘Anabaena sp.’. Therefore the effective
concentrations (ECs) and no observed effect concentration (NOEC) came out as:
EC10 >= 100 mg/ l
EC20 >= 100 mg/ l
EC50 >= 100 mg/ l
NOEC >= 100 mg/ l
The study was conducted as per the procedure described in the OECD Guideline for the
testing of Chemicals, Freshwater Algae and Cyanobacteria, Growth Inhibition Test Guideline
No. 201 Adopted on 28th July 2011.

Executive summary:

The study was conducted to determine the growth inhibition effect of ‘Brassicamidopropyl

Dimethylamine’ on algal strain ‘Anabaena sp.’.

A range finding study was conducted at four concentrations 1 mg/l, 10 mg/l, 50 mg/l & 100

mg/l of test item. No significant growth inhibition was found at any concentration.

Therefore, on the basis of range finding study, a limit test was conducted using

concentration of 100 mg/l in BG-11 medium.

The temperature was maintained within the range of 23.6-24.1°C and light intensity within

the range of 4252-4265 Lux throughout the experimentation.

Under the condition of this test, it was concluded that ‘Brassicamidopropyl Dimethylamine’

elicited no inhibition effects on the yield and specific growth rate of algal strain ‘Anabaena

sp’. Therefore, the Effective concentrations (ECs) and No observed effect concentration

(NOEC) came out as:

EC10 >= 100 mg/ l

EC20 >= 100 mg/ l

EC50 >= 100 mg/ l

NOEC >= 100 mg/ l

This study was hence, performed to assess the ‘Freshwater Algae and Cyanobacteria,

Growth Inhibition Test with “Brassicamidopropyl Dimethylamine”