Propanoic acid, 2,2,3-trifluoro-3-[1,1,2,2,3,3-hexafluoro-3-(trifluoromethoxy)propoxy]-, methyl 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:

03 December 2007 - 07 December 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study conducted under GLP. Study on ammonium salt of hydrolysis product.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EEC directive 92/96, Part C, PubNo. L383, C.1: ISO International Standard 7346-1

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

ADONA

IUPAC Name:

ADONA

Details on test material:

- Name of test material (as cited in study report): MTDID 6675
- Substance type: single-constituent substance
- Physical state: clear colorless liquid
- Analytical purity: 30.3 ±0.0% in water
- Lot/batch no.: 140499-19/10
- Stability under test conditions: Stable in water at least 96 hours
- Storage condition of test material: At room temperature in the dark

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Sampling method: 5 mL aliquots were taken at 0h and 96h from all test concentrations and controls
- Sample storage conditions before analysis: Stored in freezer until analysis

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
Method: ADONA consists of 30.3% active ingredient (a.i.) in water. The lower concentrations were prepared by subsequent dilutions of the highest test concentration (3340 mg/L total product in test medium). No special treatment other than a 10 min of magnetic stirring was necessary to completely dissolve the test substance in the test medium.
- Controls: Test medium without test substance or other additives
- Evidence of undissolved material (e.g. precipitate, surface film, etc): None, final test solutions were all clear and colorless.

Test organisms

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Carp
- Strain: Linnaeus, 1758
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands
- Age at study initiation (mean and range, SD): Not reported
- Length at study initiation (length definition, mean, range and SD): 2.4 ± 0.2 cm
- Weight at study initiation (mean and range, SD): 0.39 ± 0.10 g
- Feeding during test: No feeding from 24 hours prior to the test and during the total test period

ACCLIMATION
- Acclimation period: 12 days after delivery
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: Pelleted fish food (Nutra 3.0 T, TROUW NUTRITION, Putten, The Netherlands)
- Feeding frequency: Daily
- Health during acclimation (any mortality observed): Mortality during seven days prior to the start of the test was less than 5%

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

Hardness:

180 mg/L CaCO3

Test temperature:

21.8 - 22.9 °C

pH:

7.3 - 7.9

Dissolved oxygen:

6.5 - 9.1 mg/L

Nominal and measured concentrations:

Nominal concentration for the total product: 334, 600, 1067, 1867 and 3340 mg/L
Corresponds to analytically confirmed nominal concentration of the active ingredient: 101, 182, 323, 566 and 1012 mg a.i./L

Details on test conditions:

TEST SYSTEM
- Test vessel: 10L all-glass tanks, 9.5 L fill volume
- Aeration: Introduced after 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: 0.29 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Water used to prepare media was tap water purified by reverse osmosis; GEON waterbehandeling, Berkel-Enschot, The Netherlands
- Culture medium different from test medium: No, Adjusted ISO medium used for both
- Intervals of water quality measurement: pH, nitrate, nitrite and ammonia concentrations were measured once a week.Termperature measured every day. In addition, pH and temperature were measured before transferring the fish to the test system.

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 light: 8 dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality was recorded at 2.5, 24, 48, 72 and 96 hours. In addition, every afternoon from day 0 and every morning from day1 to observe for any dead or severely distressed fish.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Range finding study: No

Reference substance (positive control):

yes

Remarks:

Pentachlorophenol (PCP)

Results and discussion

Effect concentrations

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 012 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: ADONA induced no visible or lethal effects at or below 1012 mg a.i./L (corresponding to 3340 mg/L total product).

Details on results:

Measured concentrations are shown in Table 1. Analysis of the highest concentration showed that measured concentrations of the active ingredient were stable and in agreement with nominal concentrations during the 96h test period.
Mortality results are shown in Table 2.
- Behavioural abnormalities: None noted
- Observations on body length and weight: None noted
- Other biological observations: No mortality or clinical effects were observed
- Mortality of control: 0
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No
- Effect concentrations exceeding solubility of substance in test medium: No

Results with reference substance (positive control):

96h LC50 of 0.15 mg/L, 95% confidence of 0.10 - 0.22 mg/L. This is in agreement with the historical 96h LC50 range of 0.10 - 0.46 mg/L for carp exposed to PCP. Historical data of reference test were preformed every 3 months from April 1988 until the end of 2000, and annually since then.

Reported statistics and error estimates:

No LC50 could be calculated because the test substance proved to be non-toxic (LC50 > maximum concentration tested).

Any other information on results incl. tables

Sublethal observations / clinical signs:

Table 1 Concentrations of the ADONA in test medium
Time of sampling (hours)	Concentration^A
	Nominal (mg/L)	Analyzed (mg/L)	Relative to nominal (%)	Relative to initial (%)
0	0	<0.08	n.a.^B
	1012	969	96
96	0	<0.08	n.a^B
	1012	986	97	102
A) Concentrations were for the active ingredient and were corrected for its purity (30.3%) B) Not applicable

Table 2 Incidence of mortality and total mortality
Concentration^A ADONA (mg/L)	Initial Number of fish	Cumulative mortality					Total Mortality (%)
		2.5h	24h	48h	72h	96h
Control	7	0	0	0	0	0	0
101 (334)	7	0	0	0	0	0	0
182 (600)	7	0	0	0	0	0	0
323 (1067)	7	0	0	0	0	0	0
566 (1867)	7	0	0	0	0	0	0
1012 (3340)	7	0	0	0	0	0	0
A) Analytically confirmed nominal concentration of active ingredient. Nominal concentrations within parentheses for total product.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

No mortality in controls throughout test. Test conditions constant throughout test. Dissolved oxygen concentration > 5 mg/L. Measured concentrations ≥ 80% of nominal concentration throughout test.

Conclusions:

ADONA induced no visible or lethal effects at or below 1012 mg/L for the active ingredient (corresponding to 3340 mg/L total product).

Executive summary:

MeDONA is hydrolytically unstable. Aquatic toxicity testing on MeDONA would in practice be testing of the hydrolysis products. This test examined the ammonium salt of the hydrolysis product (ADONA).

The toxicity of ADONA to carp, Cyprinus carpio, was assessed in a 96-hour toxicity test conducted according to the OECD 203 (1992) method.

The 96-hour LC50 of ADONA to Cyprinus carpio was > 1012 mg/L active ingredient, corresponding to 3340 mg/L total product. Analysis of the highest concentration showed that measured concentrations were stable and in agreement with nominal concentrations during the 96h test period, therefore the effect parameter referenced the nominal concentrations.

The study was performed in accordance with internationally-accepted test guidelines and Good Laboratory Practice (GLP) standards. Therefore, this study is reliable without restrictions and the results are suitable for purposes of Risk Assessment, Classification & Labeling, and PBT Analysis.

Result Synopsis

Test type: Static (based on data obtained using OECD 203 methodology)

96-hr LC50 > 1012 mg/L active ingredient (3340 mg/L total product)