Reactive Orange 143

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:

9 January 2012 to 3 February 2012

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:

ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 1: Static Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Identification: FAT 40854/A TE
Description: Reddish-brown powder (determined at NOTOX)
Batch: TZ 5719 / BOP 02-11
Content: 46.2 % (4 main constituents)
Test substance storage: At room temperature in the dark
Stability under storage conditions: Stable
Expiry date: 01 April 2016
Stability in water: Stability for at least 6 hours at room temperature
Solubility in water: More than 80 g/L

Analytical monitoring:

yes

Details on sampling:

During the final limit test singular samples for possible analysis were taken from both test groups according to the schedule below.

Frequency: at t=0 h and t=96 h
Volume: 3 mL
Storage: Samples were stored in a freezer until analysis.

Additionally, singular reserve samples of 3 mL were taken from all test solutions for possible analysis. If not already used, these samples were stored in a freezer for a maximum of three months after delivery of the draft report, pending on the decision of the sponsor for additional analysis.

Vehicle:

no

Details on test solutions:

The batch of FAT 40854/A tested was a reddish-brown powder consisting of 4 main constituents (46.2 %) and the substance was completely soluble in test medium at the concentrations tested.
Preparation of test solutions started with the highest concentration of 100 mg/l. No special treatment other than careful mixing was necessary to completely dissolve the test substance in test medium. The lower test concentrations for the range-finding test were prepared by subsequent dilutions of the highest concentration in test medium. The final test solutions ranged from clear and very slightly orange at 0.10 mg/l to clear red at 100 mg/l.

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Carp (Cyprinus carpio, Teleostei, Cyprinidae)
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands
- Length at study initiation (length definition, mean, range and SD): Final limit test: 2.4 ± 0.2 cm
- Weight at study initiation (mean and range, SD): Final limit test: 0.40 ± 0.09 g
- Feeding during test: no feeding

ACCLIMATION
- Acclimation period: At least 12 days after delivery
- Acclimation conditions (same as test or not): same as the test
- Feeding: Daily with pelleted fish food (Trouvit)
- Health during acclimation (any mortality observed): In the batch of fish used for the test, mortality during the seven days prior to the start of the test was less than 5 %.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

180 mg/L expressed as CaCO3

Test temperature:

Between 21.2 and 22.1 °C

pH:

Between 7.2 and 7.9

Dissolved oxygen:

Between 6.3 and 9.4 mg/L

Nominal and measured concentrations:

Analysis of the samples taken from 100 mg/L at the start of the test showed an initial concentration of 114 mg/L. This concentration remained stable during the test period (102 % of initial).

Details on test conditions:

TEST SYSTEM
- Test vessel: 10 litres, all glass
- Aeration: Aeration was applied during the last 24 hours of exposure
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.31 g fish/litre

TEST MEDIUM / WATER PARAMETERS
Adjusted ISO medium, formulated using RO-water (tap-water purified by reverse osmosis; GEON Waterbehandeling, Berkel-Enschot, The Netherlands) with the following composition:
CaCl2.2H2O: 211.5 mg/L
MgSO4.7H2O: 88.8 mg/L
NaHCO3: 46.7 mg/L
KCl: 4.2 mg/L
- Intervals of water quality measurement: Dissolved oxygen content pH and temperature, Daily in all vessels with surviving fish, beginning at the start of the test (day 0).
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours photoperiod daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : LC50 t=24, 48, 72, 96 h
TEST CONCENTRATIONS
- Final limit study: control and 100 mg/L

Reference substance (positive control):

yes

Remarks:

pentachlorophenol (PCP)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Nominal test substance concentrations were analytically confirmed.

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

Behavioral abnormalities:
- Mortality of control: No mortality in control
- Abnormal responses: no abnormalities were observed
- Effect concentrations exceeding solubility of substance in test medium: no

Results with reference substance (positive control):

The 96h-LC50 was 0.25 mg/L based on nominal concentrations, with a 95 % confidence interval between 0.20 and 0.41 mg/L. This effect was already reached within 24 hours of exposure.

Sublethal observations / clinical signs:

Range-finding test

No mortality or clinical effects were observed at any of the test concentrations during the test period. Based on these results samples taken from nominal 100 mg/l were analysed. The initial concentration was 112 mg/l. This concentration remained stable during the test period (102-105 % of initial). Therefore, the expected LC50was above 100 mg/l.

 

Limit test

Measured concentrations

Analysis of the samples taken from 100 mg/l at the start of the test showed an initial concentration of 114 mg/l. This concentration remained stable during the test period (102 % of initial).

 

Mortality and other effects

No mortality or clinical effects were observed in the two test groups. Hence, results were in agreement with the results of the range-finding test.

Validity criteria fulfilled:

yes

Conclusions:

The 96h-LC50 and NOEC in carp is >100 and 100 mg/L, respectively.

Executive summary:

In a GLP-compliant 96 h acute toxicity study in Carp with FAT 40854/A conducted according to OECD guideline 203 and EU method C.1 using static method. The batch of FAT 40854/A tested was a reddish-brown powder consisting of 4 main constituents (46.2 %) and the substance was completely soluble in test medium at the concentrations tested. A final test was performed as a limit based on the results of a preceding range-finding test. Seven carp per test group were exposed to a control and a nominal FAT 40854/A concentration of 100 mg/l in the limit test. The total test period was 96 hours. Samples for analytical confirmation of actual exposure concentrations were taken from both test groups at the start and the end of the test period. Analysis of the samples taken from 100 mg/l at the start of the test showed an initial concentration of 112 mg/l. This concentration remained stable during the test period (102 % of initial). The study met the acceptability criteria prescribed by the protocol and was considered valid. Under the conditions of the present test FAT 40854/A induced no visible or lethal effects in carp at or below 100 mg/l (NOEC). The 96h-LC50 exceeded an analytically confirmed nominal concentration of 100 mg/l.

Description of key information

The 96h-LC50 of test substance was >100 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

In a GLP-compliant 96 h acute toxicity study in Carp with FAT 40854/A conducted according to OECD guideline 203 and EU method C.1 using static method. The batch of FAT 40854/A tested was a reddish-brown powder consisting of 4 main constituents (46.2 %) and the substance was completely soluble in test medium at the concentrations tested. A final test was performed as a limit based on the results of a preceding range-finding test. Seven carp per test group were exposed to a control and a nominal FAT 40854/A concentration of 100 mg/l in the limit test. The total test period was 96 hours. Samples for analytical confirmation of actual exposure concentrations were taken from both test groups at the start and the end of the test period. Analysis of the samples taken from 100 mg/l at the start of the test showed an initial concentration of 112 mg/l. This concentration remained stable during the test period (102 % of initial). The study met the acceptability criteria prescribed by the protocol and was considered valid. Under the conditions of the present test FAT 40854/A induced no visible or lethal effects in carp at or below 100 mg/l (NOEC). The 96h-LC50 exceeded an analytically confirmed nominal concentration of 100 mg/l.