Reactive Orange 143

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:

9 January 2012 to 11 January 2012

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:

ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))

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:

Singular samples for possible analysis were taken from all test concentrations and the control according to the schedule below.

Frequency: at t=0 h and t=48 h
Volume: 3 ml from the approximate centre of the test vessels
Storage: Samples were stored in a freezer until analysis.

At the end of the exposure period, the replicates were pooled at each concentration before sampling. Additionally, reserve samples of 3 mL were taken for possible analysis. If not 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 TE 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 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):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna (Crustacea, Cladocera) (Straus, 1820)
- Source: In-house laboratory culture with a known history.
- Age at study initiation: <24 hours
- Method of breeding: With newborn daphnids, i.e. less than 3 days old, by placing about 250 of them into 10 litres of medium in an all-glass culture vessel.
- Feeding during test: No

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

180 mg/L expressed as CaCO3

Test temperature:

The temperature of the test medium was 20.1 °C at the start of the test. The temperature continuously measured in a temperature control vessel varied between 20.1 and 20.6 °C during the test.

pH:

Between 7.6 and 8.0

Dissolved oxygen:

Between 8.9 and 9.0 mg/L

Nominal and measured concentrations:

Analyses of the samples taken from nominal 100 mg/L showed measured concentrations of 112 mg/L at the start and 116 mg/L after 48 hours of exposure. Test results were based on the nominal concentration as the measured concentrations deviated less than 20 % from nominal.

Details on test conditions:

- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass, 100 ml, normal headspace, 80 ml
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4 for the highest concentration and 2 for the lower test concentrations
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium: the following chemicals (analytical grade) are dissolved in tap water purified by Reverse Osmosis (RO-water, GEON Waterbehandeling, Berkel-Enschot, The Netherlands):
Macro salts:
CaCl2.2H2O: 211.5 mg/l
MgSO4.7H2O: 88.8 mg/l
NaHCO3: 46.7 mg/l
KCl: 4.2 mg/l
The hardness: 180 mg/l expressed as CaCO3 and the pH: 7.7 ± 0.3 after aeration.

- Culture medium different from test medium: yes, for culturing M7 medium is used

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours photoperiod daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): EC50 t=24, 48 h and NOEC

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10
- Test concentrations: control and 0.10, 1.0, 10 and 100 mg/l

Reference substance (positive control):

yes

Remarks:

potassium dichromate (K2Cr2O7)

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: Nominal test substance concentrations were analytically confirmed.

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

Behavioural abnormalities: no
- Immobility of control: no immobility was observed.
- Other adverse effects control: no

Results with reference substance (positive control):

The 24 h-EC50 was 0.53 mg/L with a 95 % confidence interval between 0.47 and 0.62 mg/L.
The 48 h-EC50 was 0.28 mg/L with a 95 % confidence interval between 0.26 and 0.32 mg/L.

Validity criteria fulfilled:

yes

Conclusions:

The 48h-EC50 of FAT 40854/A for Daphnia magna is >100 mg/L.

Executive summary:

In a GLP-compliant acute toxicity study in Daphnia magna with FAT 40854/A conducted according to OECD guideline No. 202 and EU method C. A combined limit/range-finding test was performed. Twenty daphnia per test group (4 replicates, 5 per vessel) were exposed to a control and a nominal concentration of 100 mg/l in the limit test. In the combined range-finding test ten daphnia per test group (2 replicates, 5 per vessel) were exposed to nominal concentrations of 0.10, 1.0 and 10 mg/l. The total test period was 48 hours. Samples for analytical confirmation of actual exposure concentrations were taken at the start and the end of the test period. Analyses of the samples taken from nominal 100 mg/l showed measured concentrations of 112 mg/l at the start and 116 mg/l after 48 hours of exposure. Test results were based on the nominal concentration as the measured concentrations deviated less than 20 % from nominal. The study met the acceptability criteria prescribed by the protocol and was considered valid. FAT 40854/A did not induce acute immobilization of Daphnia magna at 100 mg/l after 48 hours of exposure (NOEC). The 48h-EC₅₀ exceeded an analytically confirmed concentration of 100 mg/l.

Description of key information

The 48h-EC50 of test substance in daphnia magna is >100 and 100 mg/L, respectively.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

In a GLP-compliant acute toxicity study in Daphnia magna with FAT 40854/A conducted according to OECD guideline No. 202 and EU method C. A combined limit/range-finding test was performed. Twenty daphnia per test group (4 replicates, 5 per vessel) were exposed to a control and a nominal concentration of 100 mg/l in the limit test. In the combined range-finding test ten daphnia per test group (2 replicates, 5 per vessel) were exposed to nominal concentrations of 0.10, 1.0 and 10 mg/l. The total test period was 48 hours. Samples for analytical confirmation of actual exposure concentrations were taken at the start and the end of the test period. Analyses of the samples taken from nominal 100 mg/l showed measured concentrations of 112 mg/l at the start and 116 mg/l after 48 hours of exposure. Test results were based on the nominal concentration as the measured concentrations deviated less than 20 % from nominal. The study met the acceptability criteria prescribed by the protocol and was considered valid. FAT 40854/A did not induce acute immobilization of Daphnia magna at 100 mg/l after 48 hours of exposure (NOEC).The 48h-EC₅₀ exceeded an analytically confirmed concentration of 100 mg/l.