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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 30, 2001 to November 12, 2001 (experimental period)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- According to the guideline the 2nd dose level should be 300 mg/kg bw (authors used 200 mg/kg bw; minor restriction).
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- The study was originally intended as Limit test (2000 mg/kg bw). As mortalities occured, the lower dose of 200 mg/kg bw was selected to establish the required information for hazard assessment and hazard classification according to Directive 67/548 EEC.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
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:
- - Name of test material (as cited in study report): 3,3'-Methylene-Bis(5-Methyl-Oxazolidine)
- Synonyms: Contram MBO (1/6120) Bakzid
- Substance type: Reaction product from paraformaldehyde and 2 hydroxypropylamine (ratio of 3:2
- Physical state: Clear colourless liquid
- Analytical purity: Content of formaldehyde 42,28%
- Purity test date: September 2001
- Lot/batch No.: 24773
- Expiration date of the lot/batch: No data
- Storage conditions: At room temperature in tightly closed original containers
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, D 97633 Sulzfeld
- Age at study initiation: males 36 days, females 48 days
- Weight at study initiation: males 183-197 g and females 173-187 g at dosing
- Fasting period before study: 16 hours
- Housing: In groups of 3 in Macrolon Type 3 cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-3°C
- Humidity (%): 55 +-15%
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From Sept 24, 2001 to Nov 12, 2001
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Low dose: 10.7%; high dose undiluted
- Amount of vehicle (if gavage): 1.87 mL/kg bw
- Justification for choice of vehicle: To form a homogenous suspension
- Lot/batch no. (if required): 89 H 0149 (Sigma Aldrich)
MAXIMUM DOSE VOLUME APPLIED: 1.87 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Study was intended tp be performed at Limit test at 2000 mg/kg bw. As mortalities occured, a lower does of 200 mg/kg bw was employed - Doses:
- Single oral dose of 2000 and 200 mg/kg bw
- No. of animals per sex per dose:
- 3 males and 3 females per dose group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations 5, 15, 30, 60 min, and 3, 6, 24 h after application and then at least once daily.
Body weight measured day 0, 7, and 14.
- Necropsy of survivors performed: yes
- Necropsy of animals which died during post exposure - Statistics:
- Calculation by means of regression analysis (Probit)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 630 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No CL determined
- Mortality:
- 2000 mg/kg bw: lethal for all rats within 6 h after application (except one male which died within 24 h)
200 mg/kg bw: no mortality. - Clinical signs:
- other: Reduced motility, ataxia, reduced muscle tone and dyspnoea prior to death
- Gross pathology:
- No treatment related effects.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral toxicity (LD50) was calculated to be at 630 mg/kg bw. for male and female rats
- Executive summary:
Acute toxic class method according to OECD 423. Three males and 3 females per dose received 2000 or 200 mg/kg bw (10.7% in vehicle; high dose undiluted; volume of 1.87 ml/kg bw). All animals died at 2000 mg/kg bw. No mortality occured at 200 mg/kg bw. Afer 2 weeks of the post-exposure observation period, a necropsy was performed.
The acute oral toxicity was at 630 mg/kg bw. Classification: Harmful according to EC Commission Directive 67/548/EEC and subsequent Amendments.
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