1-acetyl-4-(4-hydroxyphenyl)piperazine

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:

2016-06-06 to 2016-12-06

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 substances 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
- Source and lot/batch No.of test material: I15FB3131
- Expiration date of the lot/batch: 2017-06-11 (retest date)
- Purity test date: 2015-09-04

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under test conditions: not indicated
- Solubility and stability of the test substance in the solvent/vehicle: solubility in water: 4.3 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. 1.8 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 1.8 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 stock solution of 100 mg/L or with the highest test concentration of 3.2 mg/L (2nd full study) applying a short period of ultrasonic treatment followed by magnetic stirring to accelerate the dissolving of the test item in the test medium. The lower test concentrations were prepared by subsequent dilutions in test medium. Final test solutions up to and including 10 mg/L were clear and colourless, while the concentration of 100 mg/L was slightly pink
- 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

ACCLIMATION
- Acclimation period: max. 4 weeks
- Acclimation conditions (same as test or not): yes
- Type and amount of food: fresh water algae.
- Feeding frequency: daily
- Health during acclimation (any mortality observed): no

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

180 mg/L as CaCO3

Test temperature:

19.7-20.3°C

pH:

At t= 0h: 7.9-8.0
At t= 48h: 8.0-8.1

Dissolved oxygen:

At t= 0h: 9.0-10.0
At t= 48h: 8.8-9.0

Salinity:

not relevant

Nominal and measured concentrations:

Final test
Nominal concentrations (1st): 1.0, 1.8, 3.2, 5.6 and 10 mg/L
Nominal concentrations (2nd): 0.32, 0.56, 1.0, 1.8 and 3.2 mg/L
Measured concentrations (mg/L) final test 1 at t=0h (fresh) : 0.783
Measured concentrations (mg/L) final test 1 at t=24h (old): 0.379
Measured concentrations (mg/L) final test 1 at t=24h (fresh): 0.778
Measured concentrations (mg/L) final test 1 at t=48h (old): 0.397
Measured concentrations (mg/L) final test 2 at t=0h (fresh): 0.305, 0.524, 0.883, 178, 3.36
Measured concentrations (mg/L) final test 2 at t=24h (old): 0.123, 0.261, 0.484, 0.947, 1.56
Measured concentrations (mg/L) final test 2 at t=24h (fresh): 0.303, 0.507, 0.941, 1.57, 2.87
Measured concentrations (mg/L) final test 2 at t=48h (old): 0.149, 0.298, 0.657, 1.11, 1.97

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): 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: x1.8
- Range finding study
- Test concentrations: control, 0.10, 1.0, 10 and 100% 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.:

0.69 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

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: no
- EC50/LC50: 48h-EC50 = 0.58 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 EC50-value was calculated at 24 and 48 hours of exposure from the probits of the percentages of affected daphnids and the corresponding average measured test item concentrations.
ToxRat Professional v. 3.2.1 (ToxRat Solutions® GmbH, Germany) was used to perform the analyses.

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of T001141 to Daphnia magna was determined in a 48-hour static test according to the OECD guideline 202.
Based on average measured test concentrations, the 48-h EC50 was determined to be 0.69 mg T001141/L (95% CL could not be determined). The results of the test can be considered reliable without restriction.

Description of key information

Based on the guideline study (Migchielsen, 2016) it is concluded that the 48 -h EC50 of the test item JNJ-119379-AAA (T001141) is 0.69 mg T001141/L (95% CL could not be determined). The results of the test can be considered reliable without restriction.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.69 mg/L