[No public or meaningful name is available]

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:

19th-21st August, 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of 2,2'-(1,3-phenylenebis(oxy))diethanol with 2-(phenoxymethyl)oxirane and 2-isocyanatoethyl methacrylate

Cas Number:

1431303-59-1

Molecular formula:

Not assigned for UVCB substance.

IUPAC Name:

Reaction products of 2,2'-(1,3-phenylenebis(oxy))diethanol with 2-(phenoxymethyl)oxirane and 2-isocyanatoethyl methacrylate

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: 3M, 6252020
- Expiration date of the lot/batch: September 2021
- Purity test date: 21st October 2019
- Purity: 100% (MTDID 58376), 14.22% ER-1GP IEM, 32.71% ER-2GP IEM, 29.91% ER-3GP IEM, 15.59% ER-4GP IEM

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in a dark, ventilated cabinet in the original container.
- Stability under storage conditions: Stable
- Stability under test conditions: Stable

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0 (blank control) and 100 mg/L
- Sampling method: Water samples (10 mL) were taken from the approximate midpoint of each test concentration vessel. For fresh solutions, samples were taken from the intermediate vessels before division into replicates. For old solutions, all replicates from each respective concentration and the control were composited before sampling. A sample of the stock solutions used in the preparation of exposure solutions was also taken.
- Sample storage conditions before analysis: Analysis was run immediately after sampling, however the results were unacceptable. Samples were stored frozen until new method was validated and extraction was possible.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The stock solution (100 mg/L) was prepared as a water-accomodated fraction (WAF) by weighing an aliquot of the test substance on a glass slide and suspending the glass slide in the total volume of dilution water in a glass beaker. The solution was clear and colorless with no undissolved material except that which was present on the slide. The vessel was covered with plastic wrap and allowed to mix slowly for 21 hours with a magnetic stir plate and Teflon-coated stir bar. Following this a 2 hour settleing period was allowed, and the resulting solution was clear and colorless with undissolved material on the glass slide and stir bar. The WAF was siphoned from the vessel, avoiding the surface and bottom of the vessel. This solution had no visible undissolved material. The 100% WAF solutions was used for exposure solutions. Exposure solutions were renewed every 24 hours.
- Controls: Test medium without test substance
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): The primary and secondary stock solutions were clear and colorless with visible undissolved material on the glass slide and stir bar. After siphoning, all exposure solutions were clear and colorless with no visible undissolved test substance.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Age at study initiation: <24 hours.
- Source: Smithers culture
- Feeding during test : No
- Presence of ephippia: none
- Culture conditions: Adult daphnids were cultured in fortified laboratory well water, pH 7.6 - 8.2, hardness 180 mg CaCO3/L, alkalinity 89-90 mg CaCO3/L. During the culture period, the water temperatures were 20 - 22°C and photoperiod was 16h light, 8 h dark (540 - 1100 lux). Daphnids in the cultures were fed once daily a suspension of green algae (Ankistrodesmus falcatus, 4X10^7 cell/mL) and YCT suspension (yeast, cereal leaves and flaked fish food).

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

180 CaCO3

Test temperature:

19-21°C

pH:

8.0-8.2

Dissolved oxygen:

8.3-9.0 mg/L

Conductivity:

700-790 uS/m

Nominal and measured concentrations:

Nominal: 100 mg/L and blank control
Measured: See Table 1

Details on test conditions:

TEST SYSTEM
- Test vessel: 250 mL glass beaker
- Volume of solution: 200 mL
- Aeration: No
- Renewal rate of test solution: At 24 hours.
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: 25 daphnids/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Well water fortified with 192 mg/L NaHCO3, 120 mg/L CaSO4.H2O, 120 mg/L MgSO4, 8.0 mg/L KCl
- Total organic carbon: 1.3 mg/L
- Particulate matter: < 1 mg/L
- Representative samples analyzed for pesticides, PCB's and toxic metals. None were detected at concentrations that are considered toxic in any of the water samples analyzed.
- Alkalinity: 88-90 mg CaCO3/L
- Culture medium different from test medium: no
- Intervals of water quality measurement: semi-annually

OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod: 16h light, 8h dark
- Light intensity: 1100 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobilization (including mortality) at 24 and 48 hours.

VEHICLE CONTROL PERFORMED: No

RANGE-FINDING STUDY
- Test concentrations: Control, 1.0, 10.0, 100 mg/L
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Mortality of control: No mortality of the control.
- Behavioral abnormalities: None reported
- Other adverse effects control: None reported
- Immobilisation of control: No immobilization of the control.

Results with reference substance (positive control):

24 hour EC50=1.9 mg/L. Reference test: 19th-20th August 2020

Reported statistics and error estimates:

Statistics run in CETIS v1.9 software (Tidepool Scientific Software, McKinleyville, CA)

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

<10% mortality in controls (0%), Dissolved oxygen concentration was ≥ 3 mg/L during test period (DO=7.4-8.7)

Conclusions:

48 hour EC50>100 mg/L (OECD 202) in Daphnia magna

Executive summary:

The 48 hour EC50 to Daphnia magna was determined in a limit test according to OECD 202 guidelines. Nominal concentrations of 100 mg/L and a blank control were run using 5 animals per vessel in four replicates and no dispersant. No immobilization nor mortalities were observed throughout the test. An EC50>100 mg/L (nominal concentration) was determined.

The study was well-documented, followed an international standard method with analytical confirmation of dose 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.