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

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:

26 February 2007 - 28 February 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: European Commission Regulation (EC), EC No. 440/2008, Part C, PubNo. L142, C.2: ISO International Standard 6341.

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: 29.9 ± 0.1% 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:

- Concentrations: 0.334, 3.34, 33.4 and 334 mg/L, which corresponded to 0.1, 1.0, 10, and 100 mg active ingredient per Liter.
- Sampling method: At the end of the exposure period (0h and 48h), the replicates were pooled at each concentration before sampling. 2 mL aliquorts were removed from the approximate centre of the test vessels.
- Sample storage conditions before analysis: Samples were stored in a 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 29.9% active ingredient (a.i.) in water. The lower concentrations were prepared by subsequent dilutions of the highest test concentration (334 mg/L in test medium). No special treatment other than a short magnetic stirring period 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):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Strain: Straus, 1820
- Source: In-house laboratory culture with known history
- Age at study initiation (mean and range, SD): < 24 hours, from parental daphnids of more than two weeks old
- Method of breeding: By acyclical parthenogenesis. Each batch started with newborn daphnids, i.e. less than 3 days old, by placing about 250 of them into 5 L of M7 medium (modified ISO medium) in an all-glass culture vessel. Cultures maintained for a maximum age of 4 weeks. After 7 days of cultivation half of the M7 medium was renewed twice a week. Cultures were maintained at 18 - 22 °C and prior to test were fed daily with a suspension of freshwater algae.
- Feeding during test: No

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Remarks on exposure duration:

Combined Limit/Range-finding test

Test conditions

Hardness:

180 mg CaCO3/L

Test temperature:

20.4 - 21.0 °C

pH:

7.6 - 8.0

Dissolved oxygen:

9.0 - 9.1 mg/L

Nominal and measured concentrations:

Nominal concentrations of active ingredient: 0.1, 1.0, 10, 100 mg/L
Nominal concentrations of total product: 0.334, 3.34, 33.4, 334 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL all-glass vessel, 80 mL fill volume
- Aeration: No
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 2 for all lower concentrations (0.1, 1.0, 10 mg a.i./L). 4 for the highest concentration (100 mg a.i./L)
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Water used to prepare media was tap water purified by reverse-osmosis (RO-water, GEON Waterbehandeling, Berkel-Enschot, The Netherlands)
- Culture medium different from test medium: Yes. Culture medium: M7; Test medium: Adjusted ISO medium. M7 is based on adjusted ISO medium supplemented with additional minerals.

OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod: 16h light, 8h dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : At 24h and 48h, immobility (including mortality) was measured.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10
- Justification for using less concentrations than requested by guideline: Combined limit/range-finding test.
- Range finding study: combined with limit test

Reference substance (positive control):

yes

Remarks:

Potassium dichromate (K2Cr2O7). Reference toxicity study conducted one week after limit/range-finding test completed.

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Remarks on result:

other: Analytically confirmed nominal concentration of active ingredient based on a content of 29.9% in the test product.

Details on results:

Concentrations at beginning and conclusion of test are shown in Table 1. Samples of the highest concentration were analyicially confirmed, measured concentrations were in agreement with nominal (99-105%). Immobilization data shown in Table 2.

- Mortality of control: None
- Other adverse effects control: None
- Abnormal responses: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None
- Effect concentrations exceeding solubility of substance in test medium: No

Results with reference substance (positive control):

The 48-hr EC50 was 0.34 mg/L with a 95% confidence interval of 0.28 - 0.40 mg/L. This result was within the historical range for this laboratory. Hence, the sensitivity of this batch of D. magna was in aggrement with the historical data collected at NOTOX.

Reported statistics and error estimates:

No EC50 could be calculated because the test substance proved to be non-toxic (EC50 > maximum concentration tested.)

Any other information on results incl. tables

Table 1. Concentrations of ADONA in the test medium
Time of sampling	Concentration^A
	Nominal (mg/I)	Measured (mg/l)	Relative to initial (%)
0 hours	0	0.00732^B	---
	99.9	105
48 hours	0	<LOD^C	94
	99.9	99.1

A) Concentrations were corrected for the purity of the test substance (29.9%)
B) Obtained by extrapolation of the calibration curve
C) LOD – limit of detection (LOD = 0.0058 mg/L)

Table 2. Acute immobilization of daphnia after 24 and 48 hours
ConcentrationA ADONA (mg/L)	Vessel number	Number Daphnia exposed	Response at 24 h		Response at 48 h
			Number	% of Total	Number^B	% of Total
Control	A	5	0	0	0	0
	B	5	0		0
	C	5	0		0
	D	5	0		0
0.334 (0.1)	A	5	0	0	0	0
	B	5	0		0
3.34 (1.0)	A	5	0	0	0 [1]	0
	B	5	0		0
33.4 (10)	A	5	0	0	0 [1]	0
	B	5	0		0
334 (100)	A	5	0	0	0	0
	B	5	0		0 [1]
	C	5	0		0
	D	5	0		0 [1]
A) Active ingredient concentrations presented between parentheses. B) Betweenbrackets: # of daphnia observed trapped at surface of test solution. Organisms were reimmersed into the respective solutions before recording of mobility.

 

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

<10% immobilization in controls, dissolved oxygen > 3 mg/L

Conclusions:

The 48-hour EC50 of ADONA to Daphnia magna was >100 mg/L (OECD 202), based on the analytically confirmed nominal concentrations of the active ingredient.

Executive summary:

DONA is an acid with pKa ca.2 and will be entirely dissociated in aquatic systems. Aquatic toxicity testing would require neutralization of stock solutions, and DONA would in practice be testing of a neutral salt. This test examined the ammonium salt of DONA (ADONA).

ADONA did not induce acute immobilization of Daphnia magna, with a 48-hour NOEC of 334 mg/L of the total product, which corresponds to a 100 mg/L of active ingredient. The 48-hour EC50 of ADONA for mobility is greater than 334 mg/L for the total product, corresponding to greater than 100 mg/L of the active ingredient.

The study was performed in accordance with internationally-accepted test guidelines and Good Laboratory Practice (GLP) standards.Therefore, use of this study for DONA is reliable with restrictions and the results are suitable for purposes of Risk Assessment, Classification & Labeling, and PBT Analysis.

Test Type: Static

48-h EC50: >100 mg/L active ingredient

This corresponds to > 344 mg/L total product