sucrose laurate

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:

August 21-25, 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 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

solid: granular

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Mitsubishi-Chemical Foods Corporation; 6912911B
- Expiration date of the lot/batch: September 11, 2018
- Purity test date: June 27, 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: cool, dark, well-ventilated space at less than 15 degrees C, with container tightly closed
- Solubility and stability of the test substance in the solvent/vehicle: forms highly viscous solution or gel when mixed with water

Sampling and analysis

Analytical monitoring:

no

Test solutions

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: About 100 mg of test substance was weighed and added to Cu-reduced dilution water. This solution was stirred for 2 hrs at room temperature. This stock solution served as the highest test concentration.

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Source: test facility bred
- Length at study initiation (length definition, mean, range and SD): 2.0 +/- 1.0 cm
- Weight at study initiation (mean and range, SD): 0.075 g, 0.069-0.081 g, 0.005 g

ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food during acclimation: live brine shrimp ad libitum
- Feeding frequency during acclimation: daily
- Health during acclimation (any mortality observed): less than 5% the week preceeding the study

FEEDING DURING TEST: No

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

Hardness:

1.2 mmol/L

Test temperature:

22.8-23.7 degrees C

pH:

8.08-8.46

Dissolved oxygen:

97-104%

Conductivity:

271 uS/cm

Nominal and measured concentrations:

Nominal: 0. 6.25, 12.50, 25.00, 50.00, 100.00 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: full glass aquaria
- Material, size, headspace, fill volume: glass, 3.0 L size, 2.0 L fill volulme
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): 48 hrs
- No. of organisms per vessel: 7
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.263 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Cu-reduced dilution water
- Total organic carbon: 0.5321 mg/L
- Metals: 1.2 mmol/L
- Chlorine: < 0.02 mg/L
- Alkalinity: 1.8 mmol/L
- Ca/mg ratio: 1.0/0.2 mmol/L
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12/12


EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality and abnormal behaviour at 24, 48, 72, and 96 hrs

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study: yes
- Test concentrations: 1.0, 10.0, and 100 mg/L
- Results used to determine the conditions for the definitive study: 100% mortality was observed at the 100 mg/L concentration. No effects were seen at the two lower concentrations. Thus the range 0-100 mg/L was suitable.

Results and discussion

Effect concentrations

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

34.77 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: None
- Mortality of control: None

Any other information on results incl. tables

Sublethal observations / clinical signs:

Fish Survival

Concentration (mg/L)	24 hrs	48 hrs	72 hrs	96 hrs
0	7	7	7	7
6.25	7	7	7	7
12.50	7	7	7	7
25.00	7	7	7	7
50.00	0	0	0	0
100.00	0	0	0	0

Applicant's summary and conclusion

Validity criteria fulfilled:

no

Conclusions:

The 96-hr LC50 for fish was 34.77 mg/L.

Executive summary:

The toxicity of the test substance to fish was determined in a OECD Guideline 203 test. Groups of 7 fish were exposed to concentrations of 0. 6.25, 12.50, 25.00, 50.00, and 100.00 mg/L for 96 hrs. Chemical analysis was not done due to difficulties analyzing the test substance. All animals in the 100 mg/L group died within 3 hrs. At the 24 hr observation, all animals in the 50.00 mg/L group had died. No other animals died during the study. The 96-hr LC50 for fish was 34.77 mg/L.