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

2017-01-27 to 2017-03-06

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:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Principles of method if other than guideline:

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

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Analytical purity:
- Source and lot/batch No.of test material: I16CB1581
- Expiration date of the lot/batch: 2019-04-04 (retest date)
- Purity test date: 2016-04-07 (certificate of analysis release date)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: solubility in water: <0.01 g/L

Analytical monitoring:

yes

Details on sampling:

- Sampling method: samples for possible analysis were taken form both test groups at the start of the test and after 96 hours from the freshly prepared solutions. At the first renewal (t=24h) and at the end of the test from the 24h old solutions 2.0 mL of volume was taken from the centre of the vessels.
- Sample storage conditions before analysis: the samples were stored in a freezer. Addionally, reserve samples of 2.0 mL were taken for possible analysis

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:
Range-finding test:
Due to an expected low water solubility of the test item, a saturated solution (SS) was prepared. The preparation of the SS started with a loading rate of 100 mg/L applying a three-day period of magnetic stirring at room temperature to ensure maximum dissolution of the test item in test medium. This resulted in a hazy dispersion containing undissolved material. The obtained dispersion was filtered through a 0.45 µm membrane filter (Whatman; RC55). The filter was pre-conditioned with a small volume of test solution that was discarded. The resulting SS was used as the test concentration. Lower test concentrations for the range-finding test were prepared by subsequent dilutions of the SS in test medium.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): All aqueous 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: 3.5 ± 0.3 cm, final test: 3.4 ± 0.2 cm
- Weight at study initiation (mean and range, SD): range-finding test: 0.58 ± 0.17 g, final test 0.55 ± 0.15 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% 7 days before test

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

not reported

Test temperature:

21-22°C

pH:

7.4-8.2

Dissolved oxygen:

6.0-9.2

Salinity:

not relevant

Nominal and measured concentrations:

Nominal concentrations (mg/L): A SS prepared at 100 mg/L
Analysed concentrations: 0 and 100% of the SS prepared at 100 mg/L
Measured concentrations (mg/L) at t=0h: 0.00065, 0.0011
Measured concentrations (mg/L) at t=24h: 0.00347, n.d. (reserve sample), 0.00339, 0.0016 (reserve sample)
Measured concentrations (mg/L) at t=96h: 0.00028 (estimated value), 0.0197

Details on test conditions:

TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 10L, all-glass filled with 9L 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

OTHER TEST CONDITIONS
- Adjustment of pH: 7.7 ± 0.3
- 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. In addition, fish that were convulsing or showing other severe forms of distress not considered transient in nature and likely to become more severe before the exposure is terminated, will be sacrificed for humane reasons. These fish will be treated as having died in the test, based on OECD guideline on humane endpoint (ENV/JM/MONO/(2000)7).

TEST CONCENTRATIONS
- Range finding study: combined/range finding study was performed
- Test concentrations: 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Remarks:

Pentachlorophenol

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.006 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: C.L. 95%: not determined

Key result

Duration:

96 h

Dose descriptor:

EC50

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
- Mortality:
- EC50/LC50: 96h-LC50 = 0.32 mg/L. the sensitivity of the fish was within the range determined with the historical data

Reported statistics and error estimates:

No LC50 values could be calculated because no mortality was observed at the maximum solubility of the test item in test medium.

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of T003066 to Carp was determined in a 96-hour static test according to the OECD guideline 203.
The 96h-LC50 exceeded a mean exposure concentration of 0.0064 mg/L, being considered the indicative maximum solubility of test item in test medium. In conclusion, the test item had no mortal effect on Carp after an exposure of 96 hours at a mean exposure concentration of 0.0064 mg/L that was obtained in a saturated solution prepared at a loading rate of 100 mg/L. The results of the test can be considered reliable without restriction.

Description of key information

The acute toxicity of T003066 to Carp was determined in a 96-hour static test according to the OECD guideline 203 (Bouwman, 2017). The 96h-LC50 exceeded a mean exposure concentration of 0.0064 mg/L, being considered the indicative maximum solubility of test item in test medium. In conclusion, the test item had no mortal effect on Carp after an exposure of 96 hours at a mean exposure concentration of 0.0064 mg/L that was obtained in a saturated solution prepared at a loading rate of 100 mg/L.