cis-2-(bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolane-4-ylmethyl benzoate

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:

2017-02-03 to 2017-02-2017

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

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Analytical purity: impurities: R036844 3.30%, unknown <0.10%
- Source and lot/batch No.of test material:
* batch: I15DB1648
* test item: 207556/A
- Expiration date of the lot/batch: 2020-04-19 (retest date)
- Purity test date: 2015-05-27 (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: <0.05 g/L

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. 2.0 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
- Sample storage conditions before analysis: the samples were stored in a freezer. Additionally, 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: Due to an expected low water solubility of the test substance saturated solutions (SS) were prepared. The preparation of test solutions started with a loading rate of 100 mg/L applying three days of magnetic stirring at room temperature to ensure maximum dissolution of the test item in the test medium. This resulted in a hazy dispersion that contained 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 resulted Saturated Solution (SS) was used as the highest test concentration. The lower test concentrations were prepared by subsequent dilutions in test medium.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): 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
- Feeding during cultivation: fresh water algae, daily

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:

19-20°C

pH:

At t= 0h: 7.8 - 8.0
At t= 48h: 7.8-7.9

Dissolved oxygen:

At t= 0h: 8.6-8.7
At t= 48h: 9.2

Salinity:

not relevant

Conductivity:

not relevant

Nominal and measured concentrations:

Final test
Nominal concentrations: control, 1.0, 10 and 100% of a SS prepared at a loading rate of 100 mg/L
Measured concentrations (mg/L) at t=0h: n.d., 0.018*
Measured concentrations (mg/L) at t=48h: n.d., 0,0040* (22% relative to initial)

* only 0 and 100% SS were analysed.

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 100 mL, all-glass 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): 4
- No. of vessels per control (replicates): 4

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: 10
- Range finding study
- Test concentrations: Twenty daphnids per group (5 per replicate, quadruplicate) were exposed to an untreated control and to the undiluted SS (100 mg/L) in the limit test. In addition, ten daphnids per group (5 per replicate, duplicate) were exposed to solutions containing 1.0 and 10% of the SS prepared at 100 mg/L in the combined range-finding.
- Results used to determine the conditions for the definitive study: Study was a limit test

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: 95% C.L.: not determined

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 = 0.58 mg/L (with a 95% confidence interval ranging from 0.49 to 0.67 mg/L). The sensitivity of the daphnia was within the range determined with the historical data collected at Charles River Den Bosch.

Reported statistics and error estimates:

The 24 and 48-h EC50 could not be calculated because no effect was observed at any of the tested concentrations

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of JNJ-16479671-AAA (T001095) to Daphnia magna was determined in a 48-hour static test according to the OECD guideline 202.
The 48-h EC50 exceeded 0.0085 mg/L, being the geometric mean measured concentration in a saturated solution prepared at a loading rate of 100 mg/L. This concentration was considered the maximum soluble concentration in test medium.
In conclusion, the test item T001095 clearly had no toxic effect to Daphnia magna up to the maximum solubility in medium obtained with a loading rate of 100 mg/L. The results of the test can be considered reliable without restriction.

Description of key information

Based on the guideline study (Tobor-Kaplon, 2016), it is concluded that the 48-h EC50 for the test item, JNJ-16479671 -AAA (T001095) based on geometric mean measured test concentrations, exceeded an average exposure concentration of 0.0085 mg T001095/L (95% CL could not be determined) being the geometric mean measured concentration in a saturated solution prepared at a loading rate of 100 mg/L. In conclusion, the test item T001095 clearly had no toxic effect to Daphnia magna up to the maximum solubility in medium obtained with a loading rate of 100 mg/L. The results of the test can be considered reliable without restriction.