Propanoic acid, 2-[4-[4,6-bis([1,1'-biphenyl]-4-yl)-1,3,5-triazin-2-yl]-3-hydroxyphenoxy]-, isooctyl ester

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31-Jan-2003 to 21-March-2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study (OECD 203)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

adopted on 17th July 1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

adopted on 29th December 1992

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Version / remarks:

adopted in April 1996

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, 12 Nohsan No 8747, 24 November 2000

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

444-090-3

EC Name:

-

Cas Number:

204848-45-3

Molecular formula:

C44 H43 N3 O4

IUPAC Name:

Propanoic acid, 2-[4-[4,6-bis([1,1'-biphenyl]-4-yl)-1,3,5-triazin-2-yl]-3-hydroxyphenoxy]-, isooctyl ester

Details on test material:

- Appearance: yellow powder

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Sampling method:
840 mg of the test substance was added to 21 L of diluent water to give a stock dispersion of 40 mg/l. A single test concentration was prepared plus one control, both in triplicate and measured at 0, 24, 72 and 48 hours.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The stock dispersion (40 mg/L) was stirred for 68-70 hours, then filtered through 0.45 µm cellulose nitrate membrane filters to give a 100% saturated test solution. The filters were pre-conditioned to the test substance by filtering some of the stock solution and discarding it before collecting the remainder for testing
- Controls: diluent water

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Source: H.T.T., Leicestershire, UK
- Length at study initiation: mean standard length: 4.4 cm (SD = 0.1)
- Weight at study initiation: mean weight: 1.18 g (SD = 0.14 g)

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions: Temperature remained within the range of 11-13 °C and dissolved oxygen within the range of 9.3-11.4 mg/L in the 14-day period immediately before the study with a 16 hours light/8 hours dark photoperiod
- Type and amount of food: The fisch were fed 1-2% of their body weight daily with commercial fry pellet but food was not given during 48 hour period immediately before exposure or during the exposure itself. No medication was given during the acclimatisation period and mortalities were recorded as 0.3% in the 7 days before the test

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

168 mg/L CaCO3

Test temperature:

13 - 14 °C

pH:

7.4 - 7.5

Dissolved oxygen:

8.4 - 8.5 mg/L

Nominal and measured concentrations:

Nominal: 100% saturation; 40 mg/L
Measured: 15.7-24.2 µg/L at 0 hours; 13.6-13.7 µg/L at 24 hours; 6.81-7.0 g/L at 72 hours and 8.30-8.39 µg/L at 96 hours

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquaria
- fill volume: 20 L
- Aeration: none
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.59 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory tap water was filtered, dechlorinated and softened by passaage through a water purification system. The water passes through a high grade activated carbon filter to remove chlorine and any organic contaminants. Aportion of the supply then passes through a water softener before final reverse osmosis (RO) treatment to produce a highly purified water supply. These two supplies are then re-mixed in the ration of approximately 2 parts "RO" water to 1 part carbon filtered water to give a laboratory supply with the desired water hardness.
- Total organic carbon: 4.0 mg/L
- Particulate matter:
- Metals: < 0.02 mg/L
- Pesticides: < 1 µg/L
- Chlorine: 0.06 mg/L
- Alkalinity: 110 mg/L
- Ca/mg ratio: 72 mg/L
- Conductivity: 460 µs/cm

OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: 16/8h day-night regime
- Light intensity: Fluorescent light, 16 hours daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
-Observations: Mortalities and symptoms after 15 minutes and 3, 24, 48, 72 and 96 hours. In addidion, subjective assessments were made on the type and incidence of sub-lethal effects compared with control fish.
-Measurements: daily oxygen content, pH and temperature

- Range finding study: with test concentrations ranging from 1.0 to 100% as saturated solutions. No toxic effect achieved at the maximum concentration. In the definite study, three aqueous mixtures were prepared at the assumed aqueous saturation level. The nominal exposure concentration quoted refers to the material as received.

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 other: % saturation

Nominal / measured:

nominal

Conc. based on:

other: saturated solution

Basis for effect:

mortality (fish)

Remarks on result:

other: No acute toxic effects within the range of solubility.

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 12 µg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: No acute toxic effects within the range of solubility.

Details on results:

- Behavioural abnormalities: no symptoms
- Mortality of control: no
- Other adverse effects control: no

Reported statistics and error estimates:

None.

Any other information on results incl. tables

Sublethal observations / clinical signs:

No mortality or adverse effects were observed following the exposure of rainbow trout to the test item, at its assumed limit of aqueous solubility under test conditions. Neither the NOEC nor the LC50 values of the substance could be calculated.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

No effects occurred within the range of solubility. Therefore, the test substance is with high probability acutely not harmful to fish.