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

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:

2016-11-14 to 2016-12-12

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

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:
* batch: I15FB3131
* test item: 207223/A
- 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: no data
- 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 both test groups at the start of the test and after 72 hours from the freshly prepared solutions. At the first renewal (t=24h) and at the end of the test from the 24h old solutions. 1.8 mL of volume was taken
- Sample storage conditions before analysis: the samples were stored in a freezer. Addionally, 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 the highest test concentration of 100 mg/L (range-finding test) or with a stock solution of 10 mg/L (final test) 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 1.0 mg/L were clear and colourless, while the concentration of 10 mg/L was very slightly pink and the 100 mg/L solution was pink.
- 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: 3.2 ± 0.3 cm, final test: 2.3 ± 0.2 cm
- Weight at study initiation (mean and range, SD): range-finding test: 0.37 ± 0.11 g, final test 0.46 ± 0.12 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:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

not reported

Test temperature:

20.1 - 21.2°C

pH:

7.5 - 8.1

Dissolved oxygen:

7.0 - 9.9

Salinity:

not relevant

Nominal and measured concentrations:

Nominal concentrations (mg/L): 0, 0.046, 0.10, 0.22, 0.46 and 1.0
Measured concentrations (mg/L) at t=0h (fresh): n.d., 0.0309, 0.0681, 0.189, 0.350, 0.871
Measured concentrations (mg/L) at t=24h (old): n.d., 0.0225, 0.0539, 0.124, 0.261, 0.602
Measured concentrations (mg/L) at t=48h (old): 0.566
Measured concentrations (mg/L) at t=72h (fresh): n.d., 0.0307, 0.0733, 0.177, 0.351
Measured concentrations (mg/L) at t=96h (old): n.d., 0.0191, 0.0499, 0.117, 0.252

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: 0.64 g fish/L

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: 0.10, 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

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.21 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: CL 95%: 0.15-0.30 mg/L

Details on results:

- Behavioural abnormalities: After 24h, 1/7 fish was snapping at the surface (concentration of 0.72 mg/L). After 72h, 3/4 fish were immobilised (concentration of 0.30 mg/L).
- Mortality of control: none
- Other adverse effects control: none

Results with reference substance (positive control):

- Results with reference substance valid? yes
- EC50/LC50: 96h-LC50 = 0.24 mg/L. the sensitivity of the fish was within the range determined with the historical data

Reported statistics and error estimates:

The 48h and 96h-LC50 could not be determined using the maximum likelihood estimation method with the probits of the percentages of dead fish as function of the logarithms of the corresponding concentrations. This was because there was no concentration between the highest concentration (A) at which 0% mortality and the lowest concentration (B) at which 100% mortality occurred. Instead, the LC50 was calculated as (AB)½, with A and B being limits of the 95% confidence interval.

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of T001141 to Carp was determined in a 96-hour static test according to the OECD guideline 203.
TThe 96h-LC50 was 0.21 mg/L based on average exposure concentrations (95% confidence interval between 0.15 and 0.30 mg/L). 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 96h-LC50 for the test item, JNJ-119379-AAA (T001141) was 0.21 mg/L based on average exposure concentrations (95% confidence interval between 0.15 and 0.30 mg/L). The results of the test can be considered reliable without restriction.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

0.21 mg/L