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REACH

2,2-Difluoroethyl Acetate

EC number: 801-773-4 | CAS number: 1550-44-3

Life Cycle description
Uses advised against

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 11 January 2016 to 08 July 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Version / remarks:

2012

Deviations:

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0.63, 1.25, 2.50, 5.00 and 10.0 mg/L (nominal concentrations).
- Sampling method: 10 mL samples were taken from all control and treatment groups at the beginning of the test (0 d), after 1 and 9 days in fresh and aged medium and at the end of the test (21 d). Sampling prior to renewal was performed on one seperate vessel at each test concentration.
- Sample storage conditions before analysis: no data available.

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION :
- Method: A test substance stock solution (1000 mg/L) was prepared by dissolving 0.1010 g test substance into 100 mL Elendt M7. Test solutions at different concentrations (0.63, 1.25, 2.50, 5.00 and 10 mg/L) were prepared by adding an appropriate volume of the stock solution and diluting with Elendt M7.
- Controls: yes, only Elendt M7 medium.
- Test concentration separation factor: 2.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): No.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM:
- Common name: Water flea.
- Age at study initiation: 6 to 24 hours old at the start of the test, not being the first brood progeny.
- Method of breeding: The stock animais were maintained in culture conditions (light, temperature, and medium) similar to those to be used in the test i.e. culture medium was Elendt M7, Light: 16-hour light and 8-hour dark cycle (light intensity: 1000 to 1500 lux), temperature: around 20°C.
- Source and age of parental stock: Daphnia magna was introduced from Nanjing University in 2010.
- Feeding during test: yes.
- Food type: Chlorella vulgaris.
- Amount: 0.1 - 0.2 mg Chlorella vulgaris by Daphnia.
- Frequency: once every day.

ACCLIMATION:
- no acclimation period as the stock animais were maintained in culture conditions (light, temperature, and medium) similar to those to be used in the test.

Test type:

semi-static

Water media type:

freshwater

Limit test:

Total exposure duration:

21 d

Hardness:

During the test period, the hardness values of the control and test media were between 221 to 232 mg (CaCO3)/L.

Test temperature:

During the test period, the temperature of the control and test media were between 19.3°C to 20.1°C.

pH:

During the test period, the pH values of the control and test media were between 7.50 and 7.99.

Dissolved oxygen:

During the test period, the Dissolved Oxygen (DO) values varied from 90% to 101% of the air saturation at the test temperature in the control and test media.

Salinity:

not concerned

Conductivity:

not measured

Nominal and measured concentrations:

- Nominal concentrations: 0 (control), 0.63, 1.25, 2.50, 5.00 and 10.0 mg/L.
- Arithmetical mean of the concentrations measured in samples taken in some freshly prepared and aged test solutions (day 0, 1, 9 and 21): not detected, 0.57, 1.16, 2.22, 4.68 and 9.67 mg/L.
The concentrations of the test substance were stable throughout the 24-hour renewal period, with all analysed concentrations within 20% of the initial concentrations. Measured concentrations are summarised in the table 1 in “Any other information on results incl tables”.

Details on test conditions:

TEST SYSTEM
- Test vessel: 50 mL headspace bottle.
- Type: closed (bottle).
- Aeration: none.
- Renewal rate of test solution: semi-static conditions, 24h renewal.
- No. of organisms per vessel: 1.
- No. of vessels per concentration (replicates): 10.
- No. of vessels per control (replicates): 10.
- Daphnid loading: 50 mL of test solution was provided for each daphnid.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M7 prepared in the test facility.
- Culture medium different from test medium: no.
- Intervals of water quality measurement: Oxygen concentration, temperature, hardness and pH values were measured at the beginning of the test (0 d), on day 3 and 9 in fresh and aged medium and at the end of the tests (21 d) in the control and in the 0.63 and 10 mg/L treatments.

OTHER TEST CONDITIONS
- Adjustment of pH: not concerned.
- Photoperiod: Light: 16-hour light and 8-hour dark cycle.
- Light intensity: 1000 to 1500 lux.

EFFECT PARAMETERS MEASURED
The number of living offspring was counted for each vessel daily. The offspring produced by each parent animal were preferably removed and counted daily from the appearance of the first brood to prevent them consuming food intended for the adult. Time to production of first brood and number of broods per animal were also reported.

TEST CONCENTRATIONS:
- Spacing factor for test concentrations: 2 in the definitve test.
- Range finding study: yes.
* Test concentrations of the range finding test: 1 and 10 mg/L nominal concentrations.
* Results used to determine the conditions for the definitive study: The inhibition of the reproduction was 11.4% at 1.00 mg/L and 51.5% at 10 mg/L after 21 days with a statistically significant difference at the highest concentration of 10 mg/L as compared to the control treatment (Dunnett's test).

Reference substance (positive control):

not specified

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

4.68 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 9.67 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks:

(of adults)

Details on results:

- Mortality: At the end of the test period, no adults died in 0.63, 1.25, 2.50 and 5.00 mg/L treatments. 1 adult died in 10.0 mg/L treatment, but this was determined as not statistically significant (according to the Chi-square test results, the significance level of p > 0.05). Thus the LOEC for survival of adults was > 10.0 mg/L (measured concentration 9.67 mg/L) and the NOEC was = 10.0 mg/L (measured concentration 9.67 mg/L).
- Reproduction: The number of live offspring produced per control parent animal was 61-83. The coefficient of variation around the mean number of living offspring produced per control parent animal in the control(s) was 9.36% (<25%). The inhibition of reproduction was assessed according to the number of produced offspring per survival parent. The inhibitions of reproduction as compared to control were 7.76%, 9.37%, 10.8% 15.9% and 23.7% for the nominal test concentrations of 0.63, 1.25, 2.50 , 5.00 and 10 mg/L respectively. According to Dunnett's test, there is a statistically significant difference only at the highest concentration of 10 mg/L compared to the control treatment.
- Other adverse effects/abnormal responses: none reported.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no.

Adult mortalities and number of live offspring observed in the definitive test are reported in the tables 2 to 7. Table 8 summarizes the reproduction effect observed in the definitive test.

Reported statistics and error estimates:

Statistical analysis on the parental survival data were performed using Chi-square tests.
Concerning the number of living offspring produced per parent animal, the mean reproduction for each concentration were compared with the control mean reproduction using an ANOVA analysis and a multiple comparison method of Dunnett' s tests (Dunnett' s tests).

Table 1: Measured test results of 2,2-difluoroethyl acetate in test medium

Nominal concentration (mg/L)	Mean measured concentration* (mg/L)	Measured concentration (mg/L)
		Day 0	Day 1		Day 9		Day 21
		fresh	aged	fresh	aged	fresh	aged
Blank control	ND	ND	ND	ND	ND	ND	ND
0.63	0.57	0.60	0.57	0.55	0.54	0.63	0.52
1.25	1.16	1.21	1.12	1.24	1.10	1.20	1.09
2.50	2.22	2.23	2.38	2.14	2.19	2.10	2.26
5.00	4.68	4.63	4.81	4.83	4.82	4.45	4.56
10.0	9.67	9.60	9.95	9.54	9.69	9.85	9.39

^*Arithmetic average of the analysed concentrations.

ND: not detected, since below the sensitivity of the analytical method.

Table 2: Daphnia magna reproduction and adult mortality in definitive test (Blank control)

Exposure time (d)		0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21
Concentration	No	No. live offspring																						Total
0 mg/L	1	0	0	0	0	0	0	0	13	0	0	12	0	0	11	0	0	0	12	0	0	0	19	67
	2	0	0	0	0	0	0	0	15	0	0	16	0	0	17	0	0	0	15	0	0	0	16	79
	3	0	0	0	0	0	0	0	16	0	0	11	0	0	19	0	0	0	17	0	0	0	18	81
	4	0	0	0	0	0	0	0	12	0	0	13	0	0	12	0	0	0	19	0	0	0	15	71
	5	0	0	0	0	0	0	0	11	0	0	16	0	0	15	0	0	0	23	0	0	0	15	80
	6	0	0	0	0	0	0	0	13	0	0	10	0	0	20	0	0	0	18	0	0	0	16	77
	7	0	0	0	0	0	0	0	12	0	0	12	0	0	10	0	0	0	13	0	0	0	14	61
	8	0	0	0	0	0	0	0	10	0	0	19	0	0	19	0	0	0	18	0	0	0	17	83
	9	0	0	0	0	0	0	0	16	0	0	13	0	0	18	0	0	0	12	0	0	0	18	77
	10	0	0	0	0	0	0	0	15	0	0	12	0	0	13	0	0	0	17	0	0	0	14	71
Exposure time (d)		0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21	Total
No. of dead adults			0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Note: The coefficient of variation for control fecundity is 9.36%.

Table 3: Daphnia magna reproduction and adult mortality in definitive test (0.63 mg/L)

Exposure Time (d)		0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21
Concentartion (mg/L)	No	No. live offspring																						Total
0.63 mg/L	1	0	0	0	0	0	0	0	11	0	0	14	0	0	11	0	0	0	16	0	0	0	17	69
	2	0	0	0	0	0	0	0	15	0	0	17	0	0	12	0	0	0	18	0	0	0	12	74
	3	0	0	0	0	0	0	0	16	0	0	18	0	0	16	0	0	0	13	0	0	0	16	79
	4	0	0	0	0	0	0	0	12	0	0	13	0	0	18	0	0	0	11	0	0	0	8	62
	5	0	0	0	0	0	0	0	18	0	0	17	0	0	17	0	0	0	12	0	0	0	13	77
	6	0	0	0	0	0	0	0	13	0	0	11	0	0	13	0	0	0	17	0	0	0	19	73
	7	0	0	0	0	0	0	0	9	0	0	12	0	0	10	0	0	0	13	0	0	0	10	54
	8	0	0	0	0	0	0	0	13	0	0	17	0	0	13	0	0	0	9	0	0	0	11	63
	9	0	0	0	0	0	0	0	17	0	0	13	0	0	12	0	0	0	13	0	0	0	17	72
	10	0	0	0	0	0	0	0	12	0	0	20	0	0	14	0	0	0	11	0	0	0	9	66
Exposure time (d)		0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21	Total
No. of dead adults			0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Table 4: Daphnia magna reproduction and adult mortality in definitive test (1.25 mg/L)

Exposure time (d)		0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21
Concetration (mg/L)	No	No. live offspring																						Total
1.25 mg/L	1	0	0	0	0	0	0	0	13	0	0	15	0	0	12	0	0	0	9	0	0	0	15	64
	2	0	0	0	0	0	0	0	12	0	0	17	0	0	17	0	0	0	11	0	0	0	12	69
	3	0	0	0	0	0	0	0	16	0	0	11	0	0	15	0	0	0	14	0	0	0	10	66
	4	0	0	0	0	0	0	0	12	0	0	12	0	0	19	0	0	0	16	0	0	0	15	74
	5	0	0	0	0	0	0	0	18	0	0	11	0	0	12	0	0	0	12	0	0	0	0	53
	6	0	0	0	0	0	0	0	13	0	0	10	0	0	17	0	0	0	18	0	0	0	15	73
	7	0	0	0	0	0	0	0	18	0	0	9	0	0	11	0	0	0	12	0	0	0	11	61
	8	0	0	0	0	0	0	0	11	0	0	17	0	0	19	0	0	0	19	0	0	0	12	78
	9	0	0	0	0	0	0	0	19	0	0	18	0	0	13	0	0	0	14	0	0	0	0	64
	10	0	0	0	0	0	0	0	16	0	0	12	0	0	15	0	0	0	17	0	0	0	15	75
Exposure time (d)		0	I	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21	Total
No. of dead adults			0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Table 5: Daphnia magna reproduction and adult mortality in definitive test (2.50 mg/L)

Exposure time (d)		0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21
Concentration (mg/L)	No	No. live offspring																						Total
2.50 mg/L	1	0	0	0	0	0	0	0	12	0	0	16	0	0	13	0	0	0	12	0	0	0	0	53
	2	0	0	0	0	0	0	0	10	0	0	14	0	0	18	0	0	0	15	0	0	0	0	57
	3	0	0	0	0	0	0	0	15	0	0	18	0	0	14	0	0	0	18	0	0	0	8	73
	4	0	0	0	0	0	0	0	18	0	0	12	0	0	17	0	0	0	11	0	0	0	9	67
	5	0	0	0	0	0	0	0	11	0	0	18	0	0	19	0	0	0	15	0	0	0	5	68
	6	0	0	0	0	0	0	0	16	0	0	13	0	0	12	0	0	0	17	0	0	0	12	70
	7	0	0	0	0	0	0	0	18	0	0	18	0	0	18	0	0	0	13	0	0	0	10	77
	8	0	0	0	0	0	0	0	13	0	0	12	0	0	11	0	0	0	18	0	0	0	8	62
	9	0	0	0	0	0	0	()	19	0	0	19	0	0	12	0	0	0	12	0	0	0	13	75
	10	0	0	0	0	0	0	0	12	0	0	11	0	0	17	0	0	0	18	0	0	0	6	64
Exposure time (d)		0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	2I	Total
No. of dead adults			0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Table 6: Daphnia magna reproduction and adult mortality in definitive test (5.00 mg/L)

Exposure time (d)		0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21
Concentration (mg/L)	No	No. live offspring																						Total
5.00 mg/L	I	0	0	0	0	0	0	0	12	0	0	16	0	0	12	0	0	0	11	0	0	0	11	62
	2	0	0	0	0	0	0	0	15	0	0	12	0	0	16	0	0	0	12	0	0	0	13	68
	3	0	0	0	0	0	0	0	12	0	0	13	0	0	11	0	0	0	16	0	0	0	16	68
	4	0	0	0	0	0	0	0	18	0	0	11	0	0	17	0	0	0	15	0	0	0	12	73
	5	0	0	0	0	0	0	0	11	0	0	17	0	0	13	0	0	0	11	0	0	0	0	52
	6	0	0	0	0	0	0	0	13	0	0	12	0	0	17	0	0	0	17	0	0	0	12	71
	7	0	0	0	0	0	0	0	10	0	0	18	0	0	12	0	0	0	13	0	0	0	0	53
	8	0	0	0	0	0	0	0	11	0	0	13	0	0	18	0	0	0	16	0	0	0	13	71
	9	0	0	0	0	0	0	0	13	0	0	11	0	0	12	0	0	0	12	0	0	0	0	48
	10	0	0	0	0	0	0	0	12	0	0	10	0	0	19	0	0	0	10	0	0	0	11	62
Exposure time (d)		0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21	Total
No. of dead adults			0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Table 7: Daphnia magna reproduction and adult mortality in definitive test (10.0 mg/L)


Exposure time (d)		0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21
Concentration (mg/L)	No	No. live offspring																						Total
10.0 mg/L	1	0	0	0	0	0	0	0	12	0	0	13	0	0	14	0	0	0	11	0	0	0	0	50
	2	0	0	0	0	0	0	0	13	0	0	16	0	0	17	0	0	0	13	0	0	0	0	59
	3	0	0	0	0	0	0	0	16	0	0	18	0	0	13	0	0	0	12	0	0	0	11	70
	4	0	0	0	0	0	0	0	13	0	0	13	0	0	18	0	0	0	0	8	0	0	12	64
	5	0	0	0	0	0	0	0	13	0	0	16	0	0	12	0	0	0	13	0	0	0	0	54
	6	0	0	0	0	0	0	0	10	0	0	15	0	0	19	0	0	0	0	0	0	0	0	44
	7	0	0	0	0	0	0	0	10	0	0	11	0	0	12	0	0	0	12	0	0	0	0	45
	8	0	0	0	0	0	0	0	11	0	0	10	0	0	15	0	0	0	19	0	0	0	11	66
	9	0	0	0	0	0	0	0	16	0	0	16	0	0	11	0	0	0	11	0	0	0	0	54
	10	0	0	0	0	0	0	0	13	0	0	17	0	0	13	0	0	0	14	0	0	0	7	64
Exposure time (d)		0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21	Total
No. of dead adults			0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1

Table 8: Reproduction inhibition during the defïnitive test

Nominal concentration (mg/L)	Initial No. of Adults	21 d
Nominal concentration (mg/L)	Initial No. of Adults	Mean Fecundity (No. live offspring per adult)	Inhibition rate(%)
Blank control	10	75	-
0.63	10	69	7.76
1.25	10	68	9.37
2.50	10	67	10.8
5.00	10	63	15.9
10.0	10	57	23.7
LOEC (Dunnett' s Test)		10.0 mg/L (measured concentration 9.67 mg/L)
NOEC (Dunnett' s Test)		5.00 mg/L (measured concentration 4.68 mg/L)

Validity criteria fulfilled:

yes

Remarks:

Both validity criteria of the OECD 211 were fulfilled. All parent animals in the control were alive (i.e. < 20%) and the number of live offsprings produced per parent daphnia surviving at the end of the test ranged from 61 to 83 (i.e. > 60).

Conclusions:

The 21-day NOECs of 2,2-Difluoroethyl acetate to Daphnia magna based on adult survival and reproduction were concluded to be superior or equal to 9.67 mg/L and equal to 4.68 mg/L, respectively.

Executive summary:

The chronic toxicity of 2,2-Difluoroethyl acetate to Daphnia magna was investigated in a 21-day semi-static test according to the OECD test guideline 211 under GLP compliance.

Ten parental water fleas (Daphnia magna) were individually exposed for 21 days under semi-static conditions (daily renewal) to a control treatment and to nominal concentrations of 0.63, 1.25, 2.5, 5 and 10 mg/L 2,2-Difluoroethyl acetate. The corresponding actual concentrations were measured using GC/MS as being equal to 0.57, 1.16, 2.22, 4.68 and 9.67 mg/L, respectively (average of concentrations measured in samples taken in some freshly prepared and aged test solutions). The survival of parental daphnids and the number of produced offspring were assessed daily.

At the end of the test, all parental daphnids survived in the control treatment and the treatments exposed to 0.57, 1.16, 2.22 and 4.68 mg/L DFEA. One parental daphnid died in the treatment exposed to 9.67 mg/L DFEA, but this was determined as not statistically significant. In terms of number of produced offspring, there is a statistically significant difference only at the highest concentration of 9.67 mg/L with an inhibition of reproduction of 23.7 % as compared to the control treatment.

The 21-day NOECs based on adult survival and reproduction in D. magna were thus concluded to be superior or equal to 9.67 mg/L and equal to 4.68 mg/L, respectively.

Description of key information

The 21-day NOECs of 2,2-Difluoroethyl acetate to Daphnia magna based on adult survival and reproduction were concluded to be superior or equal to 9.67 mg/L and equal to 4.68 mg/L, respectively.

Key value for chemical safety assessment

Fresh water invertebrates

Dose descriptor:: NOEC
Remarks:: Based on reproduction
Effect concentration:: 4.68 mg/L

Additional information

An experimental study performed under GLP compliance and in accordance with OECD test guideline 211 was flagged as a key study and assigned a Klimisch score of 1. It reports a statistically significant effect of 2,2-Difluoroethyl acetate on Daphnia magna reproduction only at the highest concentration tested of 9.67 mg/L. The 21-day NOEC based on reproduction was concluded to be equal to the concentration immediately below of 4.68 mg/L. No statistically significant effect were reported on the survival of the parental daphnids, so that the 21-day NOEC based on survival was concluded to be superior or equal to the highest concentration tested of 9.67 mg/L.

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