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

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: All methods followed were based on the latest edition of "Methods for Measuring the Acute Toxicity of Effluents and Receiving Waters to Freshwater and Marine Organisms" (EPA- 821-R-02-012) and BAL's standard operating procedure.

Deviations:

not applicable

Principles of method if other than guideline:

Bio-Analytical Laboratories (BAL), Doyline, Louisiana conducted a 48-hour acute definitive range find ing study on the sample known as ColaMoist 200 for RespirTek Incorporated, Biloxi, Mississippi for their client Colonial Chemicals Inc The test organism used was the fathead minnow, Pimephales
promelas. The test endpoint is the Lethal Concentration (LC50), which is the effluent concentration at which 50 percent of the test organisms die.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxy-N,N'-bis(2-hydroxyethyl)-N,N,N',N'-tetramethylpropane-1,3-diaminium dichloride

EC Number:

807-137-2

Cas Number:

110528-94-4

Molecular formula:

2-hydroxy-N,N'-bis(2-hydroxyethyl)-N,N,N',N'-tetramethylpropane-1,3-diaminium dichloride

IUPAC Name:

2-hydroxy-N,N'-bis(2-hydroxyethyl)-N,N,N',N'-tetramethylpropane-1,3-diaminium dichloride

Test material form:

other: 70% w/w aqueous solution, equivalent to 70% active material.The removal of water is not deemed possible without having to apply temperatures that cause some degradation of the product. Water free substance is not appropriate for this test.

Details on test material:

Upon arrival, the sample was logged in and given an identification number. The sample was weighed on an analytical balance and added to the dilution water to obtain the mg/L dilutions needed.

Test organisms

Test organisms (species):

Pimephales promelas

Details on test organisms:

The fathead minnows were raised in-house and were approximately 1 - 3 days old at test initiation. The minnows were acclimated to test temperat ure and d i lution water hardness prior to test i ni t iation. Forty-eight hou r reference toxicant tests, usi ng sodium chloride (NaCl), were conducted in order to document organism sensi tivity.
Moderately-hard reconstituted water made per EPA guidelines was used as the dilution water and the control for the toxicity tests.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

Moderately hard as required by the EPA guideline.

Test temperature:

25±1°

pH:

Measured but not detailed in report

Dissolved oxygen:

Measured but not detailed in report

Salinity:

Not saline

Details on test conditions:

A series of range finding tests were conducted until an LC50 value could be obtained. At the conclusion of the study, the following test concentrations were used: 20,000, 10,000, 5,000, 2000, I 000, 500, 250, 200, 125, 100, 50, 25 and 12.5 milligrams/Liter (mg/L). The tests were conducted using two replicates of ten animals each for a total of 20 animals per concentration.
The tests were run in either a Precision R dual programmable illuminated incubator set at a temperature of 25±1°Celsius, or in a water bath using a Remcor heated liquid circulator to maintain a temperature range of 25± 1°Celsi us. A EMCR data loggers were used to monitor diurnal temperature throughout the testing period. Light cycles and intensities were recorded twice a month.

Reference substance (positive control):

yes

Remarks:

sodium chloride - 48 hour reference tests to determine the animals sensitivity.

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

4 729 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Applicant's summary and conclusion

Conclusions:

The sample of Cola Moist 200, as received was found to be lethally toxic to the Pimephales promelas test organisms after 48 hours of exposure.
The 48-hour LC50 value for this study was 4728.71 mg/L or 4.73 g/L .
At a received concentration of 70% by weight in water, and assuming that the active ingredient alone was responsible for the deaths, extrapolating back to 100% active material, the LC50 would be calculated as 3310 mg/l.
The time used for the test was 48 hours rather than the normal 96 hours under current OECD guidelines. Extrapolation to a longer exposure time is not necessarily linear and thus the lethal dose values required for classification cannot be responsibly calculated.
However, it would suggest that ColaMoist is not considered to be toxic to fish.