Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 2 020
- 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
- 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
Constituent 1
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.