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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 266-235-8 | CAS number: 66204-44-2
- 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:
- 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Study according to guideline (OECD 202, Part I) in compliance with GLP. The reported pH was above 9 (pH 9.1, 9.3 and 9.4 at 10, 80 and 100 mg/L, respectively) after application. Only for these three concentration levels immobilisation was reported. After 48 hours reported pH values were all below 9, however mortality reached already 100% for 80 and 100 mg/L and 75% for 40 mg/L after 24 hours.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
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)
- Remarks:
- Institut Fresenius
Test material
- Reference substance name:
- 3,3'-methylenebis[5-methyloxazolidine]
- EC Number:
- 266-235-8
- EC Name:
- 3,3'-methylenebis[5-methyloxazolidine]
- Cas Number:
- 66204-44-2
- Molecular formula:
- C9H18N2O2
- IUPAC Name:
- 3,3'-methylenebis[5-methyloxazolidine]
- Details on test material:
- - Test material: Reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio of 3:2)
- Lot/Batch number: Lot No. 645109701
- Specification: 3,3’- Methylene-bis [5-methyl-oxazolidine], 50-100%
- Colourless liquid with a typical odour
- Purity: > 95%
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Nominal concentrations 20, 40 and 80 mg/l were measured as fresh solution and after 72 h.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- - Strain: Daphnia magna STRAUS
- Source: Laboratory bred, originally derived from Dr. Knie, LWA Düsseldorf (Germany)
- Age: ≤ 24 h
- Feeding of animals during test: No
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Test temperature:
- 20.5 – 22.0 °C
- pH:
- 7.31 – 9.38
- Dissolved oxygen:
- 7.4 – 8.0 mg/L
- Nominal and measured concentrations:
- - Nominal concentrations: 100, 80, 40, 20, and 10 mg/L + control
- Measured concentrations: Nominal concentrations 20, 40, and 80 mg/l analyzed as fresh solution and after 72 h (For values see table below) - Details on test conditions:
- TEST MEDIUM / WATER PARAMETER
- dilution water was prepared according to DIN 38412, part 11
TEST SYSTEM
- Static system / No renewal of test solution
- Volume of test vessels: 290 mL
- Volume/animal: 58 mL
- Number of animals/vessel: 5
- Number of vessels/ concentration: 4
- Test performed in closed vessels due to significant volatility of TS: Test solutions filled into the carboys avoiding any space of air, stoppered with glass stoppers
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Aeration of dilution water: No
- Quality/Intensity of irradiation: No data
- Photoperiod: Light/dark cycle 16 h / 8 h
TEST PARAMETER
- Immobility (no swimming within 15 sec.; moving of antenna was not considered as swimming).
SAMPLING
- Immobilisation recorded after 48 h
- pH, O2-content and temperature measured at t(0) and after 48 h
STATISTICS
- EC50 determined as geometric mean between NOEC and EC100 - Reference substance (positive control):
- no
- Remarks:
- No reference substance applied during this test. However, sensitivity of test system towards K-dichromate was tested once a month.
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 24 h
- Dose descriptor:
- EC0
- Effect conc.:
- 40 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 57 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC100
- Effect conc.:
- 80 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC0
- Effect conc.:
- 11 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 29 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- 75 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - The EC0 and EC100 were directly taken from the concentrations being tested. EC50 is the geometric mean between EC0 and EC100.
- No other effects were observed. - Results with reference substance (positive control):
- EC50 = 1.2 mg/L during the test period.
Any other information on results incl. tables
Immobility data of exposed daphnids:
Test substance [mg/l] |
|
||||||
ImmobileDaphnia |
|
|
|
||||
Number |
Percentage |
O2 [mg/l] 48 h |
pH
48 h |
Temp. 48 h |
|||
24 h |
48 h |
24 h |
48 h |
||||
Control |
No data |
0 |
0 |
7.5 |
7.40 |
20.5 |
|
100 |
100 |
100 |
7.7 |
9.02 |
20.5 |
||
80 |
100 |
100 |
7.5 |
8.92 |
20.5 |
||
40 |
75 |
100 |
7.5 |
8.79 |
20.5 |
||
20 |
0 |
0 |
7.4 |
8.57 |
20.5 |
||
10 |
0 |
0 |
7.4 |
8.38 |
20.5 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The test results indicate that the substance is acutely harmful towards invertebrates.
- Executive summary:
The substance was found to be acutely toxic towards daphnids. All validity criteria according the test Guideline are met within the study.
A steep concentration-response relationship can be established from the study results. Exposure at 40 mg/L resulted in 100% mortality within 48 hours. At 20 mg/L no mortality was observed until test termination. The EC50 was calculated as the geometric mean between EC0 and EC100.
The constituents of the reaction product (substance) are not volatile from aqueous solutions, therefore this removal mechanism could not influence the test results.It is not expected that thethe low adsorptivity of the test substance influenced test substance concentrations. Possible substance losses due to biodegradation are unlikely during the short test period of 48 h.
The constituents of the reaction product (substance) hydrolyse completely in concentrations which are expected to occur in waste waters and surface waters. Also in the media of toxicity tests, complete hydrolysis is expected, therefore the observed effects are assumed to be caused by a mixture of hydrolysis products.
Analytical measurements of the free formaldehyde content revealed that the deviation from nominal values were <20%. Therefore, the nominal concentrations can be considered as effective concentrations.
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.