D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-16 (even numbered) and C18 unsaturated acyl] derivs.

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From Mar. 11, 1991 to Mar. 15, 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study well documented, followed guideline, GLP

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

A 3:1 mixture of: 1-deoxy-1-[methyl-(1-oxododecyl)amino]-D-glucitol; 1-deoxy-1-[methyl-(1-oxotetradecyl)amino]-D-glucitol

EC Number:

407-290-1

EC Name:

A 3:1 mixture of: 1-deoxy-1-[methyl-(1-oxododecyl)amino]-D-glucitol; 1-deoxy-1-[methyl-(1-oxotetradecyl)amino]-D-glucitol

IUPAC Name:

407-290-1

Constituent 2

Reference substance name:

Glucamide 1214

IUPAC Name:

Glucamide 1214

Test material form:

other: Solid

Details on test material:

-Name of test material: C12/14 Glucamide
-TSIN: E-4194.01
-Substance type: Pure active substance
-Physical state: White solid
-Storage condition of test material: Room temperature

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

-Sampling method: At t=0 h samples for analysis were taken from the fresh prepared solutions. At t=2 h samples were taken from the 18 and 32 mg/L test solutions and at t=24 h samples of the other "spent" test solutions were taken. The sample size was 400 mL, 200 mL being taken from the duplicates of each test concentration.
-Sample storage conditions before analysis: The samples were taken in polyethylene bottles and stored frozen pending transfer to sponsor for determination of the actual concentration of the test substance in the solutions.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION OF TEST SOLUTION:
-Method: 64 mg of test material was accurately weighed out in duplicate and each portion dissolved in two liters of dilution water with the aid of ultrasonic vibration for about 15 minutes, resulting in solutions of 32 mg/L. From these solutions 150, 262.5, 480 and 840 mL were taken and diluted in the test beakers with dilution water to 1.5 L, resulting in test solutions of 3.2, 5.6, 10 and 18 mg/L. For highest test material concentration, 96 mg of test material was accurately weighed out and dissolved in three liters of dilution water, resulting in a test solution of 32 mg/L. This solution was divided in two equal portions. New concentrated solution were prepared daily throughout the test period.
-Controls: DSWL (synthetic medium) was used as a blank control.
-Evidence of undissolved material: The test substance appeared to be completely dissolved at all concentrations tested.

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
-Common name: Zebra fish
-Strain: Not reported
-Source: Commercial hatchery M.B. Ruysbroek B.V. (Noordvliet 159, Maassluis).
-Age at study initiation: Not reported
-Length at study initiation: 2.2 ± 0.1 cm
-Weight at study initiation: 0.08 ± 0.01 g
-Method of breeding: Not reported
-Feeding during test: No

ACCLIMATION
Not reported

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

None

Test conditions

Hardness:

217 mg/L as CaCO3

Test temperature:

Range 24.7-25.2°C

pH:

7.7-8. 1

Dissolved oxygen:

6.2-8.3 mg/L

Nominal and measured concentrations:

The nominal concentrations tested were 0, 3.2, 5.6, 10, 18 and 32 mg/L

Details on test conditions:

TEST SYSTEM
-Test vessel: Beaker
-Type: Open
-Material: 2000 mL all-glass beakers, each containing 1500 mL of test solution
- Aeration: Yes
-Renewal rate of test solution: 24 h renewals
-No. of fishes per vessel: 10
-No. of vessels per concentration: 2
-No. of vessels per vehicle control: 2
-Biomass loading rate: 1 fishes/150 mL

TEST MEDIUM / WATER PARAMETERS

-Source/preparation of dilution water: Dilution water was prepared from the groundwater from a locality near Linschoten (the Netherlands) by addition of the minerals. The detail composition of dilution water is mentioned in 'Annex C' of the study report.
-Total organic carbon: 1.5 mg/L
-Intervals of water quality measurement: The temperature in one of the control solutions was measured at each replacement time in one of the newly prepared control solutions and in the corresponding "spent" control solution. At the beginning and at the end of the test and at each replacement time, just before replacement and just after dosing, the pH and the oxygen concentration of the test and control solutions were measured. After 2 h the pH and the oxygen concentration were measured in the concentrations of 18 and 32 mg/L

OTHER TEST CONDITIONS
-Photoperiod: 16 h light-8 h dark regime with transition periods of 30 minutes
-Light intensity: Not reported

EFFECT PARAMETERS MEASURED:
Organisms were observed at 2 h, 24 h, 48 h, 72 h and 96 h for mortalities and other conditions such as swimming behavior, color, respiratory function or any other observable morphological or visual behavioral criterion by comparing with the controls.

-RANGE FINDING STUDY: Yes (details are not provided in study report)

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

7.5 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

-Mortality in test group: No mortality was observed up to 5.6 mg/L. At 10, 18 and 32 mg/L, none of the fish survived at 96 h observation time. Condition of all surviving fish was normal.
-Mortality of control: 0%
Details on mortality and condition are provided in Table 1' of under “Any other information on results incl. tables”

Reported statistics and error estimates:

The LC50 values and their confidence interval were calculated by means of a parametric model developed by Kooijman

Any other information on results incl. tables

Sublethal observations / clinical signs:

Table 1: Number of surviving fishes and their condition at several concentrations of test substance after several exposure times (a and b are duplicate test vessels) (study # 35072)

 

Time (Hours)	Nominal concentration of test substance (mg/L)
	0		3.2		5.6		10		18		32
	a	b	a	b	a	b	a	b	a	b	a	b
0	10^a)	10^a)	10^a)	10^a)	10^a)	10^a)	10^a)	10^a)	10^a)	10^a)	10^a)	10^a)
2	10^a)	10^a)	10^b)	10^b)	10^b)	10^b)	10^b)	10^b)	0	0	0	0
24	10^a)	10^a)	10^b)	10^b)	10^b)	10^b)	0	0	0	0	0	0
48	10^a)	10^a)	10^b)	10^b)	10^b)	10^b)	0	0	0	0	0	0
72	10^a)	10^a)	10^b)	10^b)	10^b)	10^b)	0	0	0	0	0	0
96	10^a)	10^a)	10^b)	10^b)	10^b)	10^b)	0	0	0	0	0	0

The following codes are used to denote condition:

a) Condition of all fishes, visual assessed, normal (good).

b) Condition of all fishes, visually assessed, equal to that of the control fishes.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

(except measured concentration data was not provided)

Conclusions:

The 96 h LC50 of C12/14 Glucamide to Brachydanio rerio was 7.5 mg/L, based on nominal test concentration of the test material.

Executive summary:

The 96 h LC50 of C12/14 Glucamide to Brachydanio rerio was determined under semi-static conditions following EU Method C.1 (Acute Toxicity for Fish) (comparable to OECD guideline 203 fish, acute toxicity test).

The nominal test concentrations were 0, 3.2, 5.6, 10, 18 and 32 mg/L. There were 2 replicates per test concentration with 10 fish/ replicate.

No mortality was observed up to 5.6 mg/L. At 10, 18 and 32 mg/L, none of the fish survived at 96 h observation time.

The 96 h LC50 of C12/14 Glucamide to Brachydanio rerio was 7.5 mg/L, based on nominal test concentration of the test material.

This acute toxicity test is classified as acceptable and satisfies the guideline requirement of OECD guideline 203 fish, acute toxicity test.