Phenol, styrenated, epoxidized

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:

2012, Nov 13 - 2012, Dec 13

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(1-phenylethyl)-phenyloxymethyloxirane

IUPAC Name:

(1-phenylethyl)-phenyloxymethyloxirane

Test material form:

other: yellow liquid

Details on test material:

- Name of test material (as cited in study report): Novares LR 600, (1-phenylethyl)-phenyloxymethyloxirane
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance): mixture
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state:
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions: The recoveries after 48 hours ranged from 107 % to 121 % of the start concentrations;
therefore the test item was stated as stable under the test conditions
- Storage condition of test material: Room temperature: (20 ± 5 °C); keep away from light and humidity
- Other:

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Nominal concentration < 5 mg/L in aqueous media: 100 mL of the solution in medium was extracted with 2 mL iso-octane, and the upper phase
was measured via GC/FID. 50-fold enrichment was achieved.
- Nominal concentration ≥ 5 mg/L but < 80 mg/L in aqueous media: 20 mL of the solution in medium was extracted with 2 mL iso-octane and the
upper phase was measured via GC/FID. Tenfold enrichment was achieved.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
As the solubility is ≤10 mg/L, water-accommodated fractions were prepared for the test. This was done by weighing of the nominal loads, adding the
corresponding amount of dilution water and shaking vigorously for 24 ± 1 hours in closed flasks.
The resulting solutions were filtrated through 0.45 µm filters.
Due to technical reasons, the weighed amounts of the test item for preparation of the water-accommodated fractions were differing by up to
13 % from the nominal amount. As the biological results were based on the measured concentrations, this was stated as uncritical.

Controls: Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) as positive control

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water Flea
- Strain: Berlin
- Source: LAUS GmbH, Germany (Origin: Umweltbundesamt Berlin)
- Age at study initiation (mean and range, SD): < 24 hrs; 19 hrs before the start of the test, the adult animals were separated from the young.
18 hrs later, the adults were caught with the help of a glass tube, and the newborn daphnia, aged between 0 and 18 hrs, were sieved from the
medium and placed into a 250 mL-beaker containing dilution water. After a settling-in period of 30 minutes, animals which showed no apparent
damage were used for the test.
- Method of breeding: no data
- Food type: unicellular green algae (Desmodesmus subspicatus)
- Feeding during test: none
- Medium: M4-Medium (recipe of ELENDT)
- Medium renewal: twice a week
- Photo period: 16/8 hrs, using neon tubes (lighting during test: none)
- Temperature 20 ± 2 °C (during test: 17.3 – 19.8 °C)

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48

Post exposure observation period:

no data

Test conditions

Hardness:

2.502 mmol/L; 250 mg CaCO3/L

Test temperature:

20 ± 2 °C

pH:

7.8 ± 0.2

Dissolved oxygen:

8.1 mg/L throughtout the test

Salinity:

no data

Nominal and measured concentrations:

Nominal: 0.46 / 1.00 / 2.20 / 4.60 / 10.0 mg/L (loadings)
Measured: 0.34/ 1.07/ 1.78/ 3.32/ 5.25 mg/L at start of the test

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers, nominal volume: 100 ml (containing
- Type: closed
- Aeration: Yes
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4 (each containing 65 ± 5 mL test solution)
- No. of vessels per control (replicates): 4 (each containing 65 ± 5 mL solution of control substance)
- No. of vessels per vehicle control (replicates): 4 (each containing 65 ± 5 mL dilution water intstead of test solution)

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: deionised water

OTHER TEST CONDITIONS
- Adjustment of pH: 7.8 ± 0.2
- Photoperiod: none

EFFECT PARAMETERS MEASURED: Mobility (immobilized and dead animals were counted at 24 h and 48 h of exposure)

TEST CONCENTRATIONS
- Test concentrations: nominal 0.46 / 1.0 / 2.2 / 4.6 / 10 mg/L (loadings)

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

3.5 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

1.8 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

5.5 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

2.8 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- EC50/LC50: The 24h-EC50 of Potassium dichromate was determined as 1.5 mg/L, lying within the demanded range of 0.6 – 1.7 mg/L.

Reported statistics and error estimates:

The determination of the biological results was based on the geometric mean of the measured concentration.
The geometric mean is calculated by multiplication of the n participating concentrations and extracting the nth root of the product.

Any other information on results incl. tables

The measured concentrations at the start of the test decreased with the loadings increasing and ranged between 52.5 % and 107 % of the nominal concentrations. Therefore, the determination of the biological results was based on the geometric mean of the measured concentration.

Table 8.1‑d (excerpted from original report)           Measured Concentrations

Nominal Concentration in mg/L	Measured Concentration in mg/L		% Recovery after 48 h	% of Nominal Concentration		Geometric Mean in mg/L
	0 h	48 h		0 h	48 h
BW	< LOQ	< LOQ	-	-	-	-
0.46	0.34	0.41	120.90	72.83	88.04	0.37
1	1.07	1.21	112.62	107.00	120.50	1.14
2.2	1.78	1.91	107.30	80.91	86.82	1.84
4.6	3.32	3.64	109.80	72.07	79.13	3.47
10	5.25	6.02	114.57	52.50	60.15	5.62

LOQ = Limit of quantification (0.1 mg/L)

Table 8.1‑a (excerpted from original report)       Immobilities

Nominal Concentration in mg/L	Immobility 24 hours					Immobility 48 hours
	abs.				in %	abs.				in %
0	0	0	0	0	0	0	0	0	0	0
0.46	0	0	0	0	0	0	0	0	0	0
1.0	0	0	0	0	0	0	0	0	0	0
2.2	0	0	0	0	0	0	0	1	0	5
4.6	0	0	0	0	0	5	5	4	3	85
10	4	3	4	4	75	5	5	5	5	100

Applicant's summary and conclusion

Validity criteria fulfilled:

yes