D-Glucitol, 1-deoxy-1-[methyl(1-oxononyl)amino]-

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:

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)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-methyl-N-[(2S,3R,4R,5R)-2,3,4,5,6-pentahydroxyhexyl]nonanamide

EC Number:

617-694-1

Cas Number:

85261-19-4

Molecular formula:

C16H33NO6

IUPAC Name:

N-methyl-N-[(2S,3R,4R,5R)-2,3,4,5,6-pentahydroxyhexyl]nonanamide

Test material form:

solid

Details on test material:

sample no. MTDID 48740
MEGA 9: 98.1 % (GC)
Water content: 0.3%
pH (aqueous solution 1%): 7.5

Expiry Date: 2017-12
Product Nr: MTDID 48740
Batch: 549612

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Details on test solutions:

Moderately hard, reconstituted water was used for cu lturing daphnids and as the
control/dilution water. The control/dilution water for the def initive test was prepared
by adding t he following amounts: 1.1440 g magnesium sulphate anhydrous, 1.3202 g
ca lcium su lphate, 2.1124 g sodium bicarbonate, 0.0881 g potassium chloride, 10 ml of a
4 mg/L so lution of Vitamin B12 and 40 ml of a 1 mg/ L selenium solution {as sodium
selenate solution) to 20 L of deionised water. One batch of daphnia water {August 01,
2017) was used for this test {Appendix I). It was vigorously aerated with filtered oil-free
compressed air passed through a glass Pasteur pipette prior to use.
Water quality measurements were conducted on the cont rol/dilution water prior to use
{Table 6-2). Dissolved oxygen, conductivity, temperature and pH were measured
according to the Work Instruction for Operation and Maintenance of Thermo Orion
A329 Mult iparameter Meter {BBY2 Wl-00026). Alkalinity was analysed according to
Standard Operating Procedure for pH, Conductivity, Salinity and Alkalinity {Total,
Phenolphthalein) in Water {BBY6 SOP-00026). Hardness was measured according to the
Work Instruction for Total Hardness Analysis by Titration {BBY2 Wl-00040). Ca lcium,
magnesium, sodium, and potassium were measured according to the Standard
Operation Procedure for Analysis of Various Sample Types by ICP-OES {BBY7 SOP-
00018). Alka lin ity, hardness, and analyses for ca lcium, magnesium, sodium, and
potassium were not ana lysed according to GLP.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

The daphnia culture was originally obtained from Aquatic BioSystems (Fort Collins, CO,
USA) and was used to initiate the in-house cu lture {Appendix 1). The in-house daphnia
cultures were maintained according to the Work Instruction for Culturing of Daphnia
magna and Reference Toxicant test (BBY2 Wl-00006). Prior to the test, the Daphnia
cultures were fed approximately 4.0 ml of Pseudokirchnerie/la subcapitata (PKS) and 1.0
ml of yeast-cerea l-grass fermented trout chow (YCT) three t imes per week. The
neonates used in the test were fed approximately 4.0 ml of P. subcapitata prior to test
initiation. The PKS and YCT used for feeding were also obta ined f rom Aquatic
BioSystems.
The test was initiated with four replicates per t reatment, where each replicate
contained five <24-hr old Daphnia magna neonates. Each replicate (test vessel)
consisted of 200 ml of test solution in a 250 ml glass beaker covered with Plexiglas. The
test organisms were not fed during the 48-hr exposure period.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

92 mg/L as CaCO3

Test temperature:

20.1-20.4

pH:

7.9-8.1

Nominal and measured concentrations:

Nominal 6.25 - 12.5 - 25 - 50 - 100 mg/L
Measured 6.7 - 13.6 - 27.8 - 54.2 - 111.5 mg/L

Reference substance (positive control):

yes

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The 48-h EC50 was > 100 mg/L, NOEC was 100 mg/L

Executive summary:

A sample of MTDID48740was tested to assess its potentialto cause acute

immobilisationinDaphnia magna,using the procedures outlinedinthe Maxxam Study

Planfor TOX1714,whichis based ontheStandard Operating Procedure(SOP)forthe

OECD202:Daphniasp., AcutelmmobilisationTest(BBY2SOP-00017) and the OECD 202

Daphniasp., AcutelmmobilisationTest(OECD, 2004). This 48hour static aquatic

exposuretest was conducted under controlledconditions using <24-hr oldDaphnia

magnaneonatesover a 48-hr exposure period and was carried outusingthefollowing

nominal concentrations: 6.25,12.5,25,50, and100mgTest ltem/Lin addition to a

negative (laboratory) control(0 mg/L).

At test completion, there were no immobilised or deaddaphnidsin the control orinthe

nominal test item concentrations.

Themean measured concentrations of the testitemwere within 80% to120%(106% to

112%)ofthenominal concentrations; therefore, the biologicalendpointwas calculated

usingthenominal concentrations of the testitem.

Basedon thenominalconcentrations of MTDID 48740:

1.The48-h ECso(and 95% confidencelimits)was >100 mg/L(N/A)

2. TheNo ObservedEffectConcentration (NOEC) was100mg/L

3.The LowestObservedEffectConcentration (LOEC) wasnotobserved