3-(D-gluconoylamino)propyl(2-hydroxyethyl)dimethylammonium chloride

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

Adopted April 13, 2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3-(D-gluconoylamino)propyl(2-hydroxyethyl)dimethylammonium chloride

EC Number:

257-440-3

EC Name:

3-(D-gluconoylamino)propyl(2-hydroxyethyl)dimethylammonium chloride

Cas Number:

51812-80-7

Molecular formula:

C13H29N2O7.Cl

IUPAC Name:

1-Propanaminium, 3-(D-gluconoylamino)-N-(2-hydroxyethyl)-N,N-dimethyl-, chloride

Test material form:

liquid: viscous

Details on test material:

CR Test item 207516/A
Identification Quaternium-22
Appearance Brown paste (determined by Charles River Den Bosch)
Batch 0001954895
Purity/Composition > 90%
Test item storage In refrigerator (2-8°C)
Stable under storage conditions until 16 June 2017 (retest date)

Specific details on test material used for the study:

Test item 207516/A
Identification Quaternium-22
Appearance Brown paste (determined by Charles River Den Bosch)
Batch 0001954895
Purity/Composition > 90%
Test item storage In refrigerator (2-8°C)
Stable under storage conditions until 16 June 2017 (retest date)

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Frequency at t=0 h and t=48 h
Volume 2.0 mL from the approximate centre of the test vessels
Storage Not applicable, samples were transferred to the analytical laboratory at the Test Facility and analysed on the day of sampling.
At the end of the exposure period, the replicates were pooled at each concentration before sampling.

Test solutions

Vehicle:

no

Details on test solutions:

The batch of Quaternium-22 tested was a brown paste with a purity of > 90% and completely soluble in test medium at the concentrations tested. No correction was made for the purity/composition of the test item. Preparation of test solutions started with the highest concentration of 100 mg/L applying a 19- minute period of magnetic stirring to accelerate the dissolution of the test item in medium. Lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium. All test solutions were clear and colorless at the end of the preparation procedure.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Source In-house laboratory culture with a known history.
Reason for selection This system has been selected as an internationally accepted invertebrate species.
Validity of batch Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.
Characteristics For the test selection of young daphnids with an age of < 24 hours, from parental daphnids of more than two weeks old.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

180 mg/L expressed as CaCO3

Test temperature:

20°C

pH:

7.6 - 8.1

Dissolved oxygen:

> 8.0 mg/L

Nominal and measured concentrations:

0.10, 1.0, 10 and 100 mg/L

Details on test conditions:

Number of daphnids: 20 each in the control and the highest test concentration; 10 each per intermediate test concentration.
Test vessels: 100 mL, all-glass
Loading: 5 per vessel containing 80 mL of test solution
Light: 16 hours photoperiod daily
Feeding: No feeding
Aeration: No aeration of the test solutions.
Measurements and Recordings:
- Immobility (including mortality):At 24 hours and at 48 hours.
- Dissolved oxygen & pH: At the beginning and at the end of the test, for the highest concentration and the control.
- Temperature of medium: Continuously in a temperature control vessel, beginning at the start of the test.

Reference substance (positive control):

yes

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

For the determination of the effect parameters in this study, only the highest exposure concentration proved to be of relevance since no biological effects were observed and the test was judged to be a limit test. Since the average exposure concentrations for both peaks were at the level of nominal (106 and 109% for m/z191.2 and 325.2, respectively), the effect parameters were expressed in terms of analytically confirmed nominal concentrations.
No effects were recorded at any of the concentrations tested during the exposure period.

Any other information on results incl. tables

Number of Introduced Daphnids and Incidence of Immobility:

Time (h)	Replicate	Quaternium-22; Nominal conc. (mg/L)
		Control	0.10	1.0	10	100
0	A	5	5	5	5	5
	B	5	5	5	5	5
	C	5				5
	D	5				5
	Total introduced	20	10	10	10	20
24	A	0	0	0	0	0
	B	0	0	0	0	0
	C	0				0
	D	0				0
Total immobilised		0	0	0	0	0
	Effect %	0	0	0	0	0
48	A	0	0	0	0	0
	B	0	0	0	0	0
	C	0				0
	D	0				0
Total immobilised		0	0	0	0	0
	Effect %	0	0	0	0	0

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In conclusion, the 48h-EC50 was beyond the range tested, i.e. exceeded an analytically confirmed nominal concentration of 100 mg/L.