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 aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20-Jan-2003 to 25-March-2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study (OECD test guideline 202)

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 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

adopted on 17th July 1992

Deviations:

yes

Remarks:

The softened Elendt M4 solution was adjusted from the description in the Protocol to produce a media with the required hardness to fulfil test guideline requirements.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

adopted on 29th December 1992

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)

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

Principles of method if other than guideline:

The adult mortality recorded in the culture used for this study is slightly greater than the culture mortality recommended in the guidelines. However, the total number in the culture at that time was small, hence the death of two adults appeared disproportional. As the culture fulfilled the guideline criteria in all other aspects, and had been healthy for the previous 25 days, it was considered acceptable for use, and is not considered to have affected the outcome or validity ofthe study.
The softened Elendt M4 solution was adjusted fi-om the description in the Protocol to produce a media with the required hardness to fulfil test guideline requirements. The concentrations of the following ingredients of softened Elendt M4 should read:
CaCl2.2H20 182.16 mg/l
MgS04.7H20 76.45 mg/l
KCl 3.60 mg/l
NaHCOs 40.18 mg/l
Na2Si03.9H20 10.00 mg/l
As survival and reproduction of Daphnia in the stock cultures remained satisfactory, this deviation from Protocol was not considered to have adversely affected the health of the Daphnia, nor the outcome ofthe study.

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:
80 mg of the test substance was dispersed in 2 L of test medium. Softened Elendt M4, to give a stock dispersion of 40 mg/L.Three replicate vessels were prepared for the control and the test group and measured at 0 and 48 hours.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 80 mg test substance was dispersed in 2 L of test medium, Softened Elendt M4 to give a stock dispersion of 40 mg/L. The dispension was stirred for ca. 70 hours and then filtered through a pre-conditioned 0.45 µm cellulose nitrate filter conditioned to the test substance to give a 100% saturated solution.

- Controls:
Blank water

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain: Straus
- Source: strain originating from the Institute National de Rechereche Chimique Appliqué (IRChA), France
- Age at study initiation (mean and range, SD): juvenile, less than 24 hours
- Method of breeding: stock cultures were maintained in glass vessels containing 500-800 mL Softened Elendt M4 culture medium. Cultures were fed daily with a suspension of he unicellular green alga, Chlorella vulgaris.
- Feeding during test: NO

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Test temperature:

20 ± 1 °C

pH:

7.6 - 7.7

Dissolved oxygen:

7.7 - 8.0 mg/L

Nominal and measured concentrations:

Measured:
1.19 - 2.06 µg/L at 0 hours
7.30 - 7.45 µg/L at 48 hours
geometric mean measured concentration: 3.5 µg/L
Nominal:
100% saturated solution: 40 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass jars
-Fill volume: 250 mL capacity; 200 mL test solution per vessel
- Aeration: none
- Renewal rate of test solution (frequency/flow rate): none
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3

TEST MEDIUM
- Softened Elendt M4:
CaCl2*2H20 = 182.16 mg/L
MgSO4*7H20 = 76.45 mg/L
KCl = 3.60 mg/L
NaHCO3 = 40.18 mg/L
Na2SiO3*9H2O = 10.00 mg/L

OTHER TEST CONDITIONS
- Photoperiod: lightness/dare = 16/8

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immoblisation (observation: after 24 and 48 hours)

TEST CONCENTRATIONS
- Range finding study: a preliminary range finding test was conducted using test concentrations of 1, 10, and 100% saturated solution. No toxic effects were observed at the max. concentration.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 other: % saturation

Nominal / measured:

nominal

Conc. based on:

other: saturated solution

Basis for effect:

other: immobilisation

Remarks on result:

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

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 3.5 µg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

other: immobilisation

Remarks on result:

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

Details on results:

-No immobilisation was observed during the 48 hour exposure period. Thus, neither the NOEC nor the EC50 of the test item can be calculated because these values are greater than the level of the test item achieved in aqueous solution under the conditions of this test.

Results with reference substance (positive control):

- Results with reference substance valid? YES
Time = 24 hr; EC50 = 0.85 mg/L; 95% CL = 0.64-0.98 mg/L
Time = 48 hr; EC50 = 0.73 mg/L; 95% CL = 0.54-0.87 mg/L
Highest test concentration resulting in 0% mortality: 0.32 mg/L
Lowest test concentration resulting in 100% mortality: 3.2 mg/L
No-observed effect concentration: 0.32 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

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