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Diss Factsheets

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 12, 2015-October 16, 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
During the study, an eight-hour temperature excursion (25.18-27.22 °C) was experienced by all the test groups including the blank controls and procedural control group. No control mortality and no abnormal signs noted.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(2-acryloyloxy-ethoxy) benzophenone
EC Number:
836-681-3
Cas Number:
22421-66-5
Molecular formula:
C18H16O4
IUPAC Name:
4-(2-acryloyloxy-ethoxy) benzophenone
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: 3M China Limited, Lot # 30004
- Expiration date of the lot/batch: 12/17/2015
- Factory purity: 85.7%
- Purity test date: 3/4/2015

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored at 15-25°C
- Stability under storage conditions: Stable at room temperature.

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: 1.00, 1.32, 1.73, 2.28 and 3.0 mg/L; fresh solutions at times 0 and 72 h, 24 hours old at times 24 and 96 h.
- Sampling method: 3 replicates of 5mL were sampled from test solutions and 1 sample of 5ml from control solutions. 0.5 mL aliquots were taken from the 5mL sample

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 0.9014 g of the test AEBP was dissolved in 30mL of acetone to achieve a stock solution of 30.0 mg/ml. This was then further diluted with acetone to obtain test substance solutions of 10.0, 13.2, 17.3 and 22.8 mg/ml. These solutions were stored until use during test. 1.0 mL of the solution was then applied to glass bottles which were rotated to facilitate evaporation, leaving a thin coating of the test item. 10L of test water was the added to the glass bottles and stirred magnetically (550-570 rpm) for 3-3.5 hours, to obtain test solutions of 1.0, 1.32, 1.73, 2.28, and 3.0 mg/L.
- Blank Controls: Test medium without test substance or other additives; A "procedural control" prepared by evaporating 1 mL of acetone in a bottle and stirring with 10 -L test medium as per test solutions.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): No vehicle

Test organisms

Test organisms (species):
other: Gobiocypris rarus
Details on test organisms:
TEST ORGANISM
- Common name: Rare minnow
- Source: Institue of Hydrobiology, Chinese Academy of Sciences. Lot 20140522
- Length at study initiation (range): 3.5-3.7 cm
- Weight at study initiation ( range): 0.5713-0.6735 grams

ACCLIMATION
- Acclimation period: 12 days
- Feeding frequency during acclimation: Twice daily on weekdays and one time on weekends until 24 hrs before the test.
- Health during acclimation (any mortality observed): No disease nor mortalities noted during acclimation period.
- Feeding During Test: No

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
After exposure for 96 hours, all of the surviving fish were euthanized. The method of euthanasia was to put the fish into a 0.5% water solution of etylene glycol nonphenyl ether.

Test conditions

Hardness:
142 mg/L CaCO3
Test temperature:
22.63-24.97°C. Excursion: 25.18-27.22°C
pH:
6.69-7.30
Dissolved oxygen:
97.2-99.5% air saturated value
Nominal and measured concentrations:
- Nominal: Blank Control, Procedural control, 1.00, 1.32, 1.73, 2.28, 3.00 mg/L
- Mean Measured: 0.614, 0.871, 1.22, 1.5, 2.14 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass tanks (30cm length X 20cm width X 30cm height)
- Fill volume: 10 liters
- Aeration: Water aerated for more than 24 hours before test. No aeration during test.
- Renewal rate of test solution (frequency/flow rate): Renewal every 24 hours
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: <1.0 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Ground water treated with Aquapro Pure Water System
- Total organic carbon:<2 mg/L
- Metals:All less than detection limits
- Culture medium different from test medium: No
- Intervals of water quality measurement: The periodic measurements in laboratory is performed every three months.

OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod: 12 hours light: 12 hours darkness

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality and other effects (including visible abnormalities, loss of equilibrium, swimming behavior, respiratory function, pigmentation) at 3, 24, 48, 72 and 96 hours.

TEST CONCENTRATIONS
- Range finding study : Yes, duplicate
- Test concentrations: Test 1, 0.1, 0.5, 1, 3, and 6 mg/L. Test 2, 0.7, 1.0, 3.0 and 5.0 mg/L.
- Results used to determine the conditions for the definitive study: Yes
Reference substance (positive control):
yes
Remarks:
Potassium chromate

Results and discussion

Effect concentrations
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
1.19 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CI limit: 1.05-1.36 mg/L
Details on results:
-Behavioural abnormalities: No
- Mortality of control: No
- Other adverse effects control: No
- Abnormal responses: No
- Effect concentrations exceeding solubility of substance in test medium: No
Results with reference substance (positive control):
24 hour LC50=615.6 mg/L for potassium dichromate on fish from the same lot.
Reported statistics and error estimates:
Trimmed Spearman-Karber method (EPA, Version 1.5) was used to derive the LC50 (mean values of determined concentrations).

Any other information on results incl. tables

Sublethal observations / clinical signs:

Table 1. Concentrations of Test Item in the Exposure Solution

Nominal concentrations (mg/L) Rep Measured concentration (mg/L)

0h-Fresh
Measured concentration (mg/L)

24h-Old
Measured concentration (mg/L)

72h-Fresh
Measured concentration (mg/L)

96h-Old
Control 1 ND ND ND ND
Procedural Control 1 ND ND ND ND
1.00 1 0.0940 0.0363 0.0878 0.0259
  2 0.0913 0.0360 0.0915 0.0259
  3 0.0961 0.0347 0.0916 0.0262
1.32 1 0.140 0.0542 0.118 0.0459
  2 0.119 0.0570 0.119 0.0478
  3 0.122 0.0586 0.116 0.0475
1.73 1 0.160 0.0903 0.163 0.0767
  2 0.160 0.0902 0.164 0.0727
  3 0.161 0.0906 0.166 0.0749
2.28 1 0.185 0.118 ­ ­
  2 0.182 0.117 ­ ­
  3 0.185 0.119 ­ ­
3.00 1 0.272 0.149 ­ ­
  2 0.265 0.161 ­ ­
  3 0.277 0.158 ­ ­

Note: ND indicates that the signal detected at the retention time of the analyte in the blank sample was lower than 30% of the response of the lowest standard sample.

Dilution factor of 10 for all samples

Table 2. Average Test Item Concentrations in Solution

Nominal concentrations (mg/L) Determined conc. in Fresh media Determined conc. in Old media Fresh/Nominal (%) Old/Fresh Overall mean conc. (mg/L) Overall mean/Nominal
Control ­ ­ ­ ­ ­ ­
Procedural Control ­ ­ ­ ­ ­ ­
1.00 0.921 0.308 92.1 33.5 0.614 61.4
1.32 1.22 0.518 92.7 42.4 0.871 66.0
1.73 1.62 0.826 93.8 50.9 1.22 70.8
2.28 1.84 1.18 80.7 64.1 1.51 66.2
3.00 2.71 1.56 90.4 57.5 2.14 71.2

Dilution factor of 10 for all samples

Table 3. Cumulative Mortality in Definitive Test

Nominal concentrations (mg/L) Mean Measureed conc (mg/L) Initial Population Time (hours Cumulative Mortality
Control ND 7 3 0
      24 0
      48 0
      72 0
      96 0
Procedural Control ND 7 3 0
      24 0
      48 0
      72 0
      96 0
1.00 0.614 7 3 0
      24 0
      48 0
      72 0
      96 0
1.32 0.871 7 3 0
      24 0
      48 1
      72 1
      96 1
1.73 1.22 7 3 0
      24 0
      48 1
      72 2
      96 2
2.28 1.51 7 3 0
      24 2
      48 5
      72 7
3.00 2.14 7 3 0
      24 4
      48 7

Note: ND indicates that the signal detected at the retention time of the analyte in the blank sample was lower than 30% of the response of the lowest standard sample.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
<10% mortality in controls (0%), DO >60% ASV (83.8%-100.8%)
Conclusions:
96 hour LC50 of 1.19 mg/L (OECD 203) in Gobiocypris rarus.
Executive summary:

The 96 hour LC50 of aryloxyacrylate to Gobiocypris rarus was determined according to OECD 203 guidelines. Test solutions were made by coating an acetone solution of the substance to the inside of the test vessel and allowing the acetone to evaporate. Test medium was then added. Nominal concentrations of 1.0, 1.32, 1,78, 2.28, and 3.0 mg/L, a blank control, and a procedural (acetone spiked and evaporated) control were run using 7 animals per tank, with one replicate per concentration. An LC50 of 1.19 mg/L (measured concentration) was determined.

The study was well-documented, followed an international standard method and was GLP compliant.. The study is considered reliable without restrictions.The results from this study are considered suitable for Risk Assessment, Classification and Labeling, and PBT Analysis.