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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 280-192-2 | CAS number: 83137-13-7
- 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:
- 2-Feb-2018 to 23-Feb-2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Rosin, reaction products with acrylic acid
- EC Number:
- 280-192-2
- EC Name:
- Rosin, reaction products with acrylic acid
- Cas Number:
- 83137-13-7
- Molecular formula:
- N.A. - UVCB substance
- IUPAC Name:
- Rosin, reaction products with acrylic acid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 646729
- Physical state: yellow to brownish solid
- Expiration date of the lot/batch: 19 November 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
Sampling and analysis
- Analytical monitoring:
- yes
- Remarks:
- MTDID 28640 is a complex mixture, therefore Total Organic Carbon (TOC) analysis was used as a proxy for the chemical.
- Details on sampling:
- - Concentrations: All; sampled at test initiation, and at test termination.
- Sampling method: Aliquots from test initiation were collected from the bulk test solutions. Aliquots from test completion were collected from pooled volumes of each of the control and test solution replicates.
- Sample storage conditions before analysis: Samples were collected in glass containers and stored refrigerated (2°C to 8°C) until analysis.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method:Test solutions were prepared as water soluble fractions (WAFs) individually by adding the weighed amount of MTDID 28640 to approximately 800 mL of dilution water (test medium), then adding additional dilution water to bring the volume to 1.8 L. The control was prepared in a similar manner; however, no MTDID 28640 was added. Each solution was stirred using a stir plate and stir bar to create a vortex (~15%) and covered to reduce contaminants. Stirring occurred for approximately 92 hours. Solutions were then filtered through a 0.45 µm membrane filter in a glass vacuum filtration apparatus.
- Controls: Negative (Lab) Control: Blank test medium; Negative (Procedural) Control: Blank test medium prepared as WAF test solutions
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): At the time of preparation, test item WAFs appeared clear and colorless with visible, undissolved MTDID 28640 spinning in the water column, sitting on the surface of the water, and a small amount up the sides of the beaker due to surface tension. After the 92 hour stirring period, there was no change in appearance with the exception of the 100 mg/L loading rate which began to appear cloudy at the ~44 – 48 hr observation point. After filtration, all test solutions and controls appeared clear and colorless. Test solutions and controls appeared clear and colorless at test inititation and remained consistently clear and colorless throughout the test.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water flea
- Source: In-house culture; original culture was obtained from Aquatic BioSystems (Fort Collins, CO) on April 18, 2017
- Age at study initiation: neonates < 24 hours old.
- Culturing: Daphnids were cultured in water from the same source as used during the test. 9.8% mortality was observed in daphnid cultures in the 7 days prior to the test. Daphnid cultures were fed approximately 4.0 mL of Pseudokirchneriella subcapitata (PKS) and 1.0 mL of yeast-cereal-grass fermented trout chow (YCT) three times per week. The neonates used in the test were fed approximately 5.0 mL of P. subcapitata prior to test initiation. The PKS and YCT used for feeding were also obtained from Aquatic BioSystems.
FEEDING DURING TEST
- Food type: Not fed during test
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 100 mg/L as CaCO3
- Test temperature:
- 19.0 °C to 20.4 °C
- pH:
- 8.0 to 8.2
- Dissolved oxygen:
- 5.8 mg/L to 9.1 mg/L - Test Initiation
9.0 mg/L to 9.1 mg/L - Test Completion - Conductivity:
- 321 µS/cm to 326 µS/cm
- Nominal and measured concentrations:
- Nominal; 0 mg/L, 6.25 mg/L, 12.5 mg/L, 25 mg/L, 50 mg/L, 100 mg/L
Measured (mean TOC); 0.96 mg TOC/L, 2.32 mg TOC/L, 3.86 mg TOC/L, 6.72 mg TOC/L, 9.36 mg TOC/L, 7.83 mg TOC/L, - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL glass beakers, 200 mL fill volume, covered with plexiglass, and preconditioned with appropriate test solution
- Aeration; control/dilution water aerated before use in test
- No. of organisms per vessel: five
- No. of vessels per concentration: four
- No. of vessels per control: four
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Control/dilution water was a moderately hard, reconstituted water prepared from deionised water (Millipore system). To 200 L of deionised water, the following were added; 11.4401 g magnesium sulphate anhydrous, 13.2002 g calcium sulphate, 21.1202 g sodium bicarbonate, 0.8801 g potassium chloride, 100 mL of a 4 mg/L solution of Vitamin B12 and 400 mL of a 1 mg/L selenium solution (as sodium selenate solution).
- Intervals of water quality measurement: Dissolved oxygen, temperature, and pH at test initiation and test completion. Conductivity at test initiation only.
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h:8h
- Light intensity: 528 - 566 lux
EFFECT PARAMETERS MEASURED: Immobilization at 24h, and 48h; At test completion, the immobilised daphnids were examined under a microscope to confirm if they were dead; in absence of a heartbeat.
RANGE-FINDING STUDY
- Test concentrations: 0, 0.1, 1.0, 10, and 100 mg MTDID 28640/L.
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- zinc sulphate heptahydrate (CAS# 7446-20-0)
Results and discussion
Effect concentrations
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Mobility:see Table 2
- Poor dose response (mobility) observed for nominal concentrations
- Mobility of control: No immobilization observed - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- Dose-response test: Yes
- ECx: 48-hr LC50 = 0.89 mg/L (95% CI, 0.64 mg/L to 2.35 mg/L)
- Other: The sensitivity of Daphnia magna originating from the batch used in this test, for zinc sulphate fell within the expected range of sensitivity observed previously (2 SD range of mean; 0.22 to 1.01 mg/L). The reference substance test was conducted with a month (11 days) after initiation of the testing of MTDID 28640. - Reported statistics and error estimates:
- Statistical analysis not required for determination of the EL50 for MTDID 28640.
Any other information on results incl. tables
Table 2. Observed immobilization
Nominal loading rate (mg/L) |
Cumulative No. Immobilized/Exposed at 24 hrs |
Cumulative No. Immobilized/Exposed at 48 hrs |
Mean Immobilization at 48 hrs (%) |
0 (Lab Control) | 0/0 | 0/0 | 0 |
0 (Procedural Control) | 0/0 | 0/0 | 0 |
6.25 | 0/0 | 0/0 | 0 |
12.5 | 0/0 | 4/20 | 20 |
25 | 0/0 | 3/20 | 15 |
50 | 0/0 | 10/20 | 50 |
100 | 0/0 | 6/20 | 30 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- The validity criteria of OECD TG 202 were fulfilled. Control immobilization was < 10% at the end of the test. The dissolved oxygen concentration was ≥ 3 mg/L in the control and test vessels at the end of the test.
- Conclusions:
- The 48-hour EL50 of MTDID 28640 to Daphnia magna was >100 mg/L, based on nominal loading rates (OECD TG 202).
- Executive summary:
The 48-hour EL50 of MTDID 28640 to Daphnia magna was examined in a static test conducted according to OECD TG 202. Results are based on nominal concentrations, with test solutions prepared as individual water accommodated fractions (WAFs). Undissolved MTDID 28640 was observed at all non-control test loading rates before filtration. Because MTDID 28640 is a complex mixture, Total Organic Carbon (TOC) was analyzed as a proxy for the chemical. TOC concentrations in test solutions were consistent (± 20%) between samples from test initiation and from test completion. No immobilization was observed in the control samples or at the 6.25 mg/L loading rate after 48 hours. The following immobilization levels were observed at other loading levels; at 12.5 mg/L, 20%, at 25 mg/L, 15%, at 50 mg/L, 50%, at 100 mg/L, 30%. The lack of dose response in this test led to the conclusion that the 48-hour EL50 is >100 mg/L, based on the nominal loading rate.
The test was conducted according to internationally accepted test guidelines and was GLP compliant. It is reliable with restrictions and 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.