1,3-Propanediaminium, 2-hydroxy-N1,N3-bis(2-hydroxyethyl)-N1,N1,N3,N3-tetramethyl-, chloride (1:2)

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Data is not specific to this particular substance. Published data for a similar quaternary amine substance used widely used in the feedstuffs industry. Data has been used in OECD SIDS Initial Assessment Report for SIAM 19 Berlin, Germany, 19-22 October 2004.

Data source

Reference

Reference Type:

review article or handbook

Title:

Unnamed

Year:

1998

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Choline chloride

EC Number:

200-655-4

EC Name:

Choline chloride

Cas Number:

67-48-1

IUPAC Name:

2-hydroxy-N,N,N-trimethylethanaminium chloride

Test material form:

other: Solution 75 % w/w in water

Details on test material:

Wako Pure Chemical Industries, Ltd., Lot.No.;PAR1681, Purity = 100.2%
-Test substance: choline chloride
a) Empirical Formula:C5H14NO.Cl
b) Molecular Weight: 139.63g/mol
c) Purity: = 100.2 %
d) Water Solubility: High

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Choline chloride is a quaternary amine salt, it dissociates in water into the corresponding positively charged quaternary hydroxyl alkylammonium ion and the negatively charged chloride ion.

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)

Details on test organisms:

-Test Organisms:
a) Supplier/Source: Obtained from subculture in Kureha Special Laboratory Co., Ltd.
b) Method of Cultivation: Sterile
c) Strain Number:ATCC22662
d) Any pretreatment: Acclimated for 4 days before testing

Study design

Test type:

semi-static

Water media type:

freshwater

Total exposure duration:

72 h

Test conditions

Test temperature:

Temperature in algal culture cabinet was maintained 23.0C during test period

pH:

At the start and the end of test, the pH was 8.4 - 8.6 and 9.2 - 10.4, respectively

Details on test conditions:

Test Conditions:
a) Medium: OECD medium
b) Exposure Vessel Type: 100 mL medium in a 300mL glass Erlenmeyer flask
c) Nominal Concentrations: control, 1.0, 3.2, 10, 32, 100, 320 and 1000 mg/L
d) Vehicle/Solvent and Concentrations: Not used
e) Sock Solution Preparations and Stability: Test substance was diluted with OECD medium. Test substance was stored in freezer. The stability of the chemical was confirmed by IR absorption spectrum. Under the stock condition, IR spectrum of the test substance at the end of test was same at the start.
f) Number of Replicates: 3
g) Initial Cell Number: 10,000 cells/mL
h) Water Temperature: 23+/-2C
i) Light Condition: 4000 - 5000 lux, continuously j) Shaking: 100 rpm

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

72 h

Dose descriptor:

other: ErC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 2

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

32 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Reported statistics and error estimates:

Statistical Method:
a) Data Analysis: Probit method for EC50 if applicable. 1-way ANOVA (a=0.05) and Dunnett's method (a=0.05, both side) for NOEC, after Bartlett's homoscedastic test.
b) Method of Calculating Mean Measured Concentrations (i.e. arithmetic mean, geometric mean, etc.): The nominal concentration was used for calculation.

Applicant's summary and conclusion

Conclusions:

Based on these data choline chloride is considered unlikely to be harmful to aquatic organisms including algae. Therefore as a read across to this material it is assessed that ColaMoist 200 is also unlikely to be harmful to algae.