D-Glucitol, 1-deoxy-1-(methylamino)-, N-C8-10 acyl derivs.

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:

2013-10-09 to 2013-10-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study performed under GLP, no deficiencies

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.

EC Number:

940-284-1

Cas Number:

1591782-62-5

Molecular formula:

C15H31NO6 C17H35NO6

IUPAC Name:

D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.

Constituent 2

Reference substance name:

Glucamide 810

IUPAC Name:

Glucamide 810

Details on test material:

- Physical state: Colourless powder
- Sum formula: C15H31NO6 (C8-Glucamide) C17H35NO6 (C10-Glucamide)
- Molecular weight:
C8-Glucamide: 321.42 g/Mol
C10-Glucamide 349.47 g/Mol
- Storage condition of test material: Room temperature, protected from light, in original container.

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: A limit concentration of nominal 100 mg/ was tested. The limit concentration is based on the results of a non GLP preliminary range finding test.

- Sampling method:
The limit concentration and the control were analytically verified by LC-MS/MS at the start (0 h) and at the end of the exposure (48 h) as specified below.
At the start of the exposure (0 h), samples were taken immediately after preparation of the limit concentration and analysed. At the end of the exposure (48 h), samples were taken directly from the test vessels. The method was validated prior to this study according to SANCO 3029/99 rev.4 (2000-07-11).
- Sample storage conditions before analysis: All original samples were stored at room temperature until sample preparation. Prepared samples were stored in an autosampler at room temperature until analysis.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:A stock solution of 100 mg/L was freshly prepared with dilution water. Agitation.


- Eluate: Dilution water
- Differential loading:A limit concentration of nominal 100 mg/ was tested.
- Controls: Four replicates of dilution water without test item tested under the same conditions as the test goups.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna (STRAUS)
- Strain: Clone 5
- Source: Institut für Wasser-, Boden- Lufthygiene (WaBoLu), further own breeding
- Age at study initiation (mean and range, SD): 2 to 24 h
- Method of breeding: In 2-3 L glass vessels with appr. 1.8 L culture medium, at 20 +/- 2 °C, in an incubator, 16 h illumination, light intensity of
max. 20 µExm-2 x s-1; culture feeding: at least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus with an algae cell density of > 10^6 cells/mL.
- Feeding during test: No feeding

ACCLIMATION
- Acclimation period: at least 2 h
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: No feeding
- Health during acclimation (any mortality observed): Healthy, no mortality observed

DILUTION WATER:
Dilution water ISO test water, according to OECD 202, Annex 3:
Component Concentration [mg/L]
KCl 5.76
NaHCO3 64.8
CaCl2  2 H2O 294
MgSO4  7 H2O 123
pH-value: 7.8  0.2

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

No

Test conditions

Hardness:

Dilution water at test start: 249 (mg CaCO3/L)

Test temperature:

At test start: 21.4 °C (Water)

pH:

Water Quality Parameters at the Start of the Exposure (0 h)
(measured in one additional replicate of the limit concentration and the control)

Nominal test item
concentration
[mg/L] pH-Value
100 8.16
Control 7.92

Water Quality Parameters at the End of the Exposure (48 h)
(measured in all replicates)
Nominal test item
concentration
[mg/L] pH-Values
Replicates
1 2 3 4
100 7.97 7.97 7.95 7.96
Control 8.29 7.96 7.95 7.95

Dissolved oxygen:

Water Quality Parameters at the Start of the Exposure (0 h)
(measured in one additional replicate of the limit concentration and the control)

Nominal test item
concentration
[mg/L] Dissolved O2-Concentration
100 8.24
Control 8.16

Water Quality Parameters at the End of the Exposure (48 h)
(measured in all replicates)
Nominal test item
concentration
[mg/L] Dissolved O2-Concentration
Replicates
1 2 3 4
100 8.14 8.02 8.11 8.17
Control 7.99 7.88 8.04 8.18

Salinity:

Not measured, freshwater

Nominal and measured concentrations:

Please refer to "Any other information on materials and methods"

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers
- Type (delete if not applicable): closed with parafilm
- Material, size, headspace, fill volume: Glass beakers (4 cm ID x 7 cm H), 50 mL capacity
- Aeration: No
- Renewal rate of test solution (frequency/flow rate): Static test
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): None


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: see above
- Conductivity: Dilution water at test start: 666 µS/cm
- Culture medium different from test medium: Elendt M4 acc. to ELENDT (1990), modified to a total hardness of 160 to 180 mg CaCO3/L
- Intervals of water quality measurement: At test start and at test end


OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16:8 light:dark cycle
- Light intensity: Diffuse light, illumination strength max. 20 µE x m-2 x s-1


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Immobility was determined in all groups after 24 h and 48 h.

TEST CONCENTRATIONS
- Range finding study:
Immobilisation Rates in the non GLP preliminary Test
(n = 20, divided into 2 replicates with 10 daphnids each)
Nominal
test item
concentration
[mg/L] IMMOBILISATION [%]
24 h 48 h
Replicates Replicates
1 2 MV 1 2 MV
100 0 0 0 0 0 0
Control 0 0 0 0 0 0

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: highest test item concentration 100 mg/L

Effect concentrations 2

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:

- Mortality of control: 0 %
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- EC50/LC50: 2.12 (CI 1.87 - 2.37) mg/L

Reported statistics and error estimates:

The effects of the limit concentration of 100 mg/L were deduced directly from the observed immobilisation rates.

Any other information on results incl. tables

Immobilisation Rates of the Definitive Test after 24 and 48 hours of Exposure

 (n = 20, divided into 4 replicates with 5 daphnids each)

Nominal test item concentration [mg/L]	IMMOBILISATION [%]
	24 h					48 h
	Replicates					Replicates
	1.	2.	3.	4.	MV	1.	2.	3.	4.	MV
100	0	0	0	0	0	0	0	0	0	0
Control	0	0	0	0	0	0	0	0	0	0

MV   = mean value

 

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

At the limit concentration of 100 mg/L of the test item C8/C10-Glucamide AC93/13, no effects were observed on Daphnia magna.

Executive summary:

In the acute immobilisation test withDaphnia magna (STRAUS), the effects of the limit concentration of 100 mg/L of the test item C8/C10-GlucamideAC93/13 (batch number: AC 93/13) were determined according to OECD 202 (2004).The limit test was conducted under static conditionsover a period of 48 hours from2013-10-09 to 2013-10-14, with the definitive exposure phase from2013-10-09 to 2013-10-11, at Dr. U. Noack-Laboratorien, Käthe-Paulus-Str. 1,31157 Sarstedt, Germany.

Twenty daphnids were exposed to the limit concentrationand the control.

The test item C8/C10-GlucamideAC93/13 was analytically verified by LC-MS/MS at the start of the exposure (0 h) and at the end of the exposure (48 h) for the limit concentration of 100 mg/L and the control.

The measured concentration of the C8 fractionof the test item at the start of the exposure (0 h) was 102 % of the nominal value. The measured concentration of the C10 fractionof the test item at the start of the exposure (0 h) was 104 % of the nominal value. The measured concentration of the C8 fractionof the test item at the end of the exposure (48 h) was 102 % of the nominal value. The measured concentration of the C10 fraction of the test item at the end of the exposure (48 h) was 97 % of the nominal value.

The measured concentrations of the C8 and the C10 fraction of the test item C8/C10-Glucamide AC93/13 were within ± 20 % of the nominal values, indicating that the limit concentration of 100 mg/L of the test item C8/C10-Glucamide AC93/13 was successfully maintained for the duration of the test. Therefore, the effects given are based on the nominal concentration of the test item C8/C10-Glucamide AC93/13.

Water quality parameters (i.e. pH-value and dissolved oxygen concentration), measured at the start (0 h) and at the end of the exposure (48 h), were within the acceptable limits. The validity criteria of the test guidelines were fulfilled.

EC-Values, NOEC and LOEC

(based on the nominal concentration of the test item)

C8/C10-Glucamide AC93/13
	Test duration [h]	Nominal test item concentration   [mg/L]	Confidence interval p = 95% [mg/L]
EC10/ EC50/ EC100	24	> 100	Not applicable
	48	> 100	Not applicable
NOEC	48	100	---
LOEC	48	> 100	---

At the limit concentration of 100 mg/L of the test item C8/C10-Glucamide AC93/13,

no effects were observed on Daphnia magna.