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 aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016-07-01 to 2016-07-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

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

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: not available.

Analytical monitoring:

yes

Details on sampling:

- Sampling method: samples for possible analysis were taken form all test concentrations and the control at t=0 and t=48h. 1.0 mL of volume was taken from the approximate centre of the test vessels. At the end of the exposure period, the replicates were pooled at each concentration before sampling. In addition, the filter containing undissolved residue was kept for possible analysis.
- 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.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): All final test solutions were clear and colourless.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water-flea
- Source: in-house laboratory culture with a known history
- Age at study initiation (mean and range, SD): <24h (from parental daphnids of more than 2 weeks old)
- Method of breeding: 250 newborn daphnids (i.e. less than 3 days old) are placed into 5 litres of medium in an all-glass culture vessel. Medium is M7. After 7 days of cultivation half of the medium is renewed twice a week.
- Feeding during test: no

ACCLIMATION
- Acclimation period: not relevant

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

180 mg/L as CaCO3

Test temperature:

20-21°C

pH:

At t= 0h: 8.0
At t= 48h: 8.0

Dissolved oxygen:

At t= 0h: 8.6-9.0
At t= 48h: 8.7-8.8

Salinity:

not relevant

Nominal and measured concentrations:

Final test
Nominal concentrations: 1.0, 10 and 100% of a SS prepared at 100 mg/L
Concentrations analysed: 0 , 100 % of a SS prepared at 100 mg/L
Measured concentrations (mg/L) at t=0h: n.a., < LOQ*
Measured concentrations (mg/L) at t=48h: n.a., < LOQ*

n.a. = not applicable
* The limit of quantification of the method was determined to be 0.01 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 100 mL, glass beaker filled with 80mL
- Aeration: not during the test
- Type of flow-through (e.g. peristaltic or proportional diluter): no flow-through
- Renewal rate of test solution (frequency/flow rate):no renewal, static system
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 4
- Test medium: adjusted ISO medium

OTHER TEST CONDITIONS
- Photoperiod: 16h light daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobility was defined as those organisms which are not able to swim within 15 seconds after gentle agitation of the test container and was monitored after 24 and 48 hours of continuous treatment with the test substance.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: x10
- Range finding study
- Test concentrations: 1.0 and 10% of a SS prepared at a loading rate of 100 mg/L
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Remarks:

Potassium Dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: At the nominal loading rate of 100 mg/L, no quantifiable amount of test substance were present in the test medium from the start of testing on

Details on results:

- Mortality of control: none
- Other adverse effects control: no
- Abnormal responses: none
Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no

Results with reference substance (positive control):

- Results with reference substance valid? yes
- EC50/LC50: 48-h EC50 = 0.39 mg/L. the sensitivity of the daphnia was within the range determined with the historical data collected at WIL Research Europe.

Reported statistics and error estimates:

The 24 and 48-h EC50 could not be calculated because the observed effects were below 50%.

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of T003422 to Daphnia magna was determined in a 48-hour static test according to the OECD guideline 202. Based on the results obtained during the present Daphnia study, the 48-h EC50 was beyond the range tested, i.e. exceeded the concentration obtained in a loading rate of 100 mg/L, being considered the maximum solubility of the test item in test medium. In conclusion, the test substance had no significant inhibitory effect on Daphnia magna after an exposure of 48 hours up to and including the highest loading rate of 100 mg/L, no quantifiable amount of test substance were present in the test medium from the start of testing on (i.e. < 0.01 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 Daphnia magna according to OECD guideline 202, was considered as the key study for endpoint coverage. The 48-h EC50 was found after an exposure of 48 hours in a static test in freshwater and was beyond the range tested, i.e. exceeded the concentration obtained in a loading rate of 100 mg/L, being considered the maximum solubility of the test item in test medium. Based on the results it can be concluded that T003422 is not harmful to aquatic invertebrates.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

> 100 mg/L

Additional information

The 48h-EC50 was beyond the range tested, i.e. exceeded the concentration obtained in a loading rate of 100 mg/L, being considered the maximum solubility of the test item in test medium. In conclusion, the test substance had no significant inhibitory effect on Daphnia magna after an exposure of 48 hours up to and including the highest loading rate of 100 mg/L, no quantifiable amount of test substance were present in the test medium from the start of testing on (i.e. < 0.01 mg/L)