[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:

28 April 2020-30 April 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1,10-decanediol dimethacrylate (CAS 6701-13-9) and 10-methacryloyl-oxy-decylphosphate

Molecular formula:

C18H30O4 and C14H27O6P

IUPAC Name:

Reaction mass of 1,10-decanediol dimethacrylate (CAS 6701-13-9) and 10-methacryloyl-oxy-decylphosphate

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: 3M, batch: 5674800

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored at room temperature (15-25°C) in a ventilated cabinet, away from heat, acids, bases and amine in a container tightly closed.
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions and during storage: Preliminary monitoring showed that test item is not stable under the test conditions (measured concentration variation > 20%).

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Blank control and 100 mg/L
- Sampling method: 10 mL of test media was transferred 50 mL plastic centrifuge tubes for control and fortification. Sample fortification, if required, was carried out at this time. At least one untreated control and two controls fortified with a known amount of test item were analyzed in each analytical set to demonstrate acceptable performance of the method.
- Sample storage conditions before analysis: Samples extracted same day as analysis. Stored under refrigerated conditions (4 ± 2°C).

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances):
Test solutions were prepared by Water Accommodated fraction (WAF). A test concentration of 100 mg/L (loading rate level) were added directly to test media and mixed for 24 hours on an agitation table with a glass magnetic stirrer. The solution was then centrifuged for 5 minutes at 3000 RCF. Following this, the aqueous phase (WAF) was drawn for testing. Test flasks were filled directly from the test solution containers immediately after preparation.
- Controls: Test medium without test substance or other additives.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): No vehicle
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): After centrifugation, solutions were clear with a film at the surface. However, the WAF was drawn off after this step to make final test solutions.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Strain/clone: Straus
- Age at study initiation: Daphnids were less than 24 hours old and produced from parthenogenically reproducing brood female population
- Source: Culture at SGS France Laboratoire de Rouen
- Culture conditions: Daphnids were cultured in freshwater reconstituted with salts. Water temperatures were 19.4 - 20.0°C, with a light dark cycle of 16:8 hours. Quality control checks were run twice per month using potassium dichromate to verify culture sensitivity.

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Test temperature:

19.4-20.0°C

pH:

7.5-8.3

Dissolved oxygen:

8.3-8.5

Nominal and measured concentrations:

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

Details on test conditions:

TEST SYSTEM
- Test vessel: 125 mL, glass beakers.
- Test solution volume: 25 mg/L
- Aeration: No
-Renewal rate: 24 hours
- No. of organisms per vessel: five
- No. of vessels per concentration (replicates): four
- No. of vessels per control: four

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Demineralized water reconstituted with salts. The test media composition is consistent with standard “ASTM media” described in the labs SOP with two vitamins (thiamine hydrochloride and vitamin B8). Product is as follows: Calcium sulphate dihydrate 120.0 mg/L, Magnesium sulphate heptahydrate 246.0 mg/L, Sodium bicarbonate 192.0 mg/L, Potassium chloride 8.0 mg/L, Sodium selenite 0.00438 mg/L, Vitamin B12 0.0001 mg/L, Biotin 0.00007 mg/L, Thiamine Hydrochloride 0.0074 mg/L.
- Culture medium different from test medium: No

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: light/dark cycle 16/8 hours

EFFECT PARAMETERS MEASURED : Immobilization (including mortality) at 24 and 48 hours

VEHICLE CONTROL PERFORMED: No vehicle

RANGE-FINDING STUDY
- Test concentrations: Blank control and 100 mg/L.
- Results used to determine the conditions for the definitive study: Yes
One range-finding test was performed under non GLP condition. The test showed that test item did not have an impact on the daphnia mobility at 100 mg/l loading rate. 1,10-Decandioldimethacrylate (1,10 D-D) and 10-Methacryloyl-oxy-decylphosphate (10 M-O-D concentration were measured at the beginning and at the end of the test by HPLC MS/MS. Per the range finding test results, the final test was performed as a limit tests at the loading levels of 100 mg/L. The preliminary monitoring showed that test item is not stable under the test conditions (measured concentration variation > 20%). The definitive test was performed with solution renewal after 24h to maintain the exposure level.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 104 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Behavioral abnormalities: None
- Mortality of control: No mortality in control daphnids
- Effect concentrations exceeding solubility of substance in test medium: No

Results with reference substance (positive control):

K2Cr2O7 sensitivity test: 24hr EC50=1.24 mg/L (95% ≥ 0.6 - ≤ 2.1)

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=8.3-8.5)

Conclusions:

48 hour EL50>104 mg/L (loading rate) in Daphnia magna (OECD 202).

Executive summary:

The 48 hour EL50 of MTDID 23327 to Daphnia magna was determined according to OECD 202 guidelines. A nominal concentration (loading rate) of 100 mg/L (prepared as Water Accommodated Fraction), and a blank laboratory control were run in a limit test, using 5 animals per vessel, with four replicates per concentration. An EL50 of >104 mg/L 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.