D-Glucitol, 1,5-anhydro-1-C-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-, 2,3,4,6-tetrakis(2,2-dimethylpropanoate), (1S)-

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016-06-01 to 2016-09-02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Guidance document on aquatic toxicity testing of difficult items and mixtures, OECD series on testing and assessment number 23, December 14, 2000

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Analytical purity: 98.0 to 102.0% (99.7% based on chromatographic purity HPLC and chromatographic Purity GC)
- Batch n°: I15AB0305
- Expiration date: 2017-01-23 (re-test date)
- Purity test date: 2015-02-19 (certificate of analysis release date)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition: at room temperature
- Stability under storage conditions: Analysis of stability, homogeneity and concentration of the test item under test conditions were not
performed as part of this study.

Analytical monitoring:

yes

Details on sampling:

- Sampling method: singular samples for possible analysis were taken form all test concentrations with surviving fish and the control at t=0 and t=96h. Volume was 1.0 mL. The filter containing the undissolved residue was also retained for possible analyses
- Sample storage conditions before analysis: the samples were stored in a freezer. Additionally, reserve samples of 1.0 mL were taken for possible analysis.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Preparation of test solutions started with a loading rate of 100 mg/L applying a three-day period of magnetic stirring to ensure maximum dissolution of the test item in test medium. The resulting aqueous mixture was filtered through a 0.45 µm membrane filter (Whatman; RC55) to remove the undissolved fraction of the test item. The obtained Saturated Solution (SS) was used as the highest test concentration. The lower test concentrations were prepared by subsequent dilutions of the SS in test medium. All final test solutions were clear and colourless.
- Controls: yes
- Evidence of undissolved material (e.g. precipitate, surface film, etc): final test solutions were clear and colourless

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Carp
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands
- Length at study initiation (length definition, mean, range and SD): range-finding test: 2.1 ± 0.4 cm, limit test: 2.7 ± 0.3 cm
- Weight at study initiation (mean and range, SD): range-finding test: 0.33 ± 0.16 g, limit test 0.32 ± 0.06 g
- Feeding during test: no

ACCLIMATION
- Acclimation period: at least 12 days after delivery
- Acclimation conditions (same as test or not): yes
- Type and amount of food: pelleted fish food
- Feeding frequency: daily
- Health during acclimation (any mortality observed): mortality less than 5% seven days before test

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

not reported

Test temperature:

20.0-24 °C

pH:

7.5-8.0

Dissolved oxygen:

5.4-8.7

Salinity:

not relevant

Conductivity:

not indicated

Nominal and measured concentrations:

Range-finder:
Nominal concentrations: 100% of SS
Measured concentrations at t=0h: < LOQ
Measured concentrations at t=24h: 0.000915 mg/L
Measured concentrations at t=96h: < LOQ

Final test:
Nominal concentrations: 0 and 100% of the SS prepared at 100 mg/L
Measured concentrations at t=0h: n.d., 0.202 mg/L
Measured concentrations at t=24h: n.d., 0.0214 mg/L
Measured concentrations at t=96h: n.d., 0.0107 mg/L

n.d. = not detected

Details on test conditions:

TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 6.5L, all-glass filled with 5L test solution
- Aeration: not during the test
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): not reported
- No. of vessels per control (replicates): not reported
- Biomass loading rate: 0.45 g fish/L

OTHER TEST CONDITIONS
- Photoperiod: 16h light daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Fish were considered to be dead when no reaction was observed after touching the caudal peduncle and visible breathing movements were absent.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: none (limit test)
- Range finding study: yes
- Test concentrations: 100% of a SS
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Remarks:

pentachlorophenol

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.028 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: none
- Other adverse effects control: no
- Abnormal responses: none

Results with reference substance (positive control):

- Results with reference substance valid? yes
- EC50/LC50: 96-h LC50 = 0.32 mg/L.

Reported statistics and error estimates:

The LC50 could not be calculated because the test item appeared to be not toxic.

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of T0003422 to Carp was determined in a 96 hour static limit test according to the OECD guideline 203. Under the conditions of the present study, The 96-hLC50 exceeded the TWA concentration of 0.028 mg/L being considered maximum soluble concentration in medium (LL50>100 mg/L). The results of the test can be considered reliable without restriction.

Description of key information

The study of Tobor-Kaplon (2017), investigating the acute toxicity of T003422 in carp according to OECD guideline 203, was considered as the key study for endpoint coverage. A LC50 > 0.028 mg/L (based on TWA concentration, being considered maximum soluble concentration in medium and corresponding with a lethal loading rate of > 100 mg/L) was obtained after an exposure of 96 hours in a static test in freshwater. Based on the results it can be considered that T003422 is not harmful to fish.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

> 0.028 mg/L