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

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:

2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity 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. SCF-KEE-00462
active content (100% minus by-products): 90,0 % (w/w)

Propylene glycol: 0,8 % (w/w)
(by GC)

NMG: 0,9 % (w/w)
(by GC)

Polyol/sorbitol: 0,7 % (w/w)
(by HPLC)

NAME: 0,1 % (w/w)
(by GC)

Aliphatic acid: 3,6 % (w/w)
(by GC)

Water: 0,1 % (w/w)
(by Karl-Fischer titration)

Methanol: <0,1 % (w/w)
(by GC)

Other by-products: 3,8 % (w/w)
(by GC)

Appearance at 20°C: beige wax (by visual examination)

Batch No.: SCF-KEE-00462
Analytical Report No.: 17-009338-1

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Details on test solutions:

Good quality tap water which had been dechlorinated for at least 24 hours was used. The total
hardness of the test water was 121.6 mg (CaC03)/L and pH was 8.08 at room temperature.
Characteristics of the dilution water are measured at least twice a year by Jiangsu Provincial
Center for Disease Prevention and Control.

Test organisms

Test organisms (species):

other: Gobiocypris rarus

Details on test organisms:

The Rare minnow, Gobiocypris rarus, was used in the test on the basis of such important
practical criteria as, for example, their ready availability throughout the year, ease of maintenance,
convenience for testing and any relevant economic, biological or ecological factors. The test
species of Rare minnow, Gobiocypris rarus (Batch No.: F20180315G), were bred by our own lab.
A population of a single stock was used in the test.
(1) Holding of fish
Fish to be used in the test were held for at least 7 days in water of the quality and temperature tobe used in the test.
A photoperiod of 12 hours light, provided by overhead fluorescent tubes, and 12 hours dark was
maintained. The oxygen concentration was varied from 86 % to 93 % of the air saturation. And
the temperature was controlled between 22.9°C and 23.3°C, pH: 7.63 ~7.79.
The fish was fed daily during the holding period on proprietary fish food. They were held without
food for approximately 24 hours before being placed into the test vessels.

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

130 - 137 mg/L CaCO3

Test temperature:

23 - 23.1 °C

pH:

7.68 - 7.84

Dissolved oxygen:

90 - 96 %

Nominal and measured concentrations:

100 mg/L and control

Reference substance (positive control):

yes

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Results with reference substance (positive control):

LC50 24h = 293 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The results showed that under valid semi-static conditions (24 h renewal), the 96 h-LC50 of test
substance to fish (Rare minnow, Gobiocypris rarus) was greater than the nominal concentration
of 100 mg/L (mean measured concentration 95.7 mg/L), while the maximum concentration
causing no mortality (96 h-LC0) was equal to the nominal concentration of 100 mg/L (mean
measured concentration 95.7 mg/L). i.e.:
96 h-LC5o > 100 mg/L (mean measured concentration 95.7 mg/L);
96 h-LCo = 100 mg/L (mean measured concentration 95.7 mg/L).

Executive summary:

Undersemi-static conditions(24h renewal),the acutetoxicityofthetestsubstanceofGlucamide

9(GA9)toRareminnow(Gobiocyprisrarus)was conducted accordingto:"The guidelines for

thetesting of chemicals" (HJ/T153-2004),"The Guidelines forthe TestingofChemicals, Effects

onBiotocSystems" (the 2ndedition) (2013); and with referenceto Procedure 203 of the

"Guidelines forTestingof Chemicals" of theOECD: "Fish, AcuteToxicityTest" (1992).

Arange-finding testandthenalimit testwereperformedrespectively.Nominalconcentrations of

1.0,10.0and100 mg/L wereusedin the range-findingtest,while thenominalconcentration of

100 mg/L wasused in thelimittest. The mean of the measured concentrations was 95.7 mg/L,

ranging from 92.5mg/Lto 98.6mg/L duringthe test period (0, 24,48,72, 96h).The analytical

results showed thatthe measuredconcentration of the test substancewasconsistent inthe test

medium throughout the 96-hour test period (deviation within20%). Thus asemi-staticprocedure

(24 h renewal) was reasonable.

Five fish per treatment with no replication were tested in the range-finding test while three

replicates ofsevenfisheachwere tested in the control and limitconcentration ofthe limit test.

The test fishes were exposed for 96 hours to the testsolution.

During the test period, the pH values of the control mediums and test mediums were between

7.66 and 7.84 the Dissolved Oxygen (DO) values variedfrom 90 % to 96 % of the airsaturation

at the test temperature; thetotalhardnesswas in the range of 130 mg (CaC03)/Lto137 mg

(CaC03)/L; the temperature of the test mediums was maintainedin the range of23.0 °Cto23.2°C

and allfishes inthe controlgroupwere normal. With thesameconditions, K2Cr207was used as

the positive controlsubstance, and the resulting24h-LC50was293mg/L. So the study met the

acceptability criteria prescribed by the protocol and Test Guidelines (The mortality ofcontrol~

10%; pH: 6.0~8.5; dissolvedoxygenconcentration:>60% of the airsaturationvalue;

temperature: (23±2) °C;24h-LC50of K2Cr207in the range of200mg/L to 400 mg/L). Thus the

test wasconsideredvalid.

During the test period, all fish in the controlgroupsand treatedgroupswere alive and appeared

normal. The resultsshowedthat under validstatictest conditions, the 96 h-LC50of testsubstance

to fish (Rare minnow,Gobiocypris rarus)wasgreaterthan the nominalconcentration of100

mg/L (mean measuredconcentration95.7 mg/L), while the maximum concentration causing no

mortality (96 h-LC0)wasequalto the nominalconcentrationof l 00 mg/L (mean measured

concentration 95.7 mg/L). i.e.:

 

96 h-LC50>100 mg/L (mean measured concentration 95.7 mg/L);

96 h-LC0=100 mg/L (mean measured concentration 95.7 mg/L).