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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 24, 2001 to March 07, 2002 (date of Study Plan to Final Report date)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- No data on the purity of the test substance
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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 66204-44-02
- IUPAC Name:
- 66204-44-02
- Details on test material:
- - Name of test material (as cited in study report): CONTRAM™MBO (1/6120) / Bakzid
- Substance type: Formaldehyde releaser
- Physical state: Clear colourless liquid
- Analytical purity: Content of formaldehyde 42,28%
- Composition of test material, percentage of components: 3,3'-methylenebis[5-methyl- oxazolidine]; releasable formaldehyde 43,52%; Reaction product from paraformaldehyde and 2 hydroxypropylamine (ratio of 3:2)
- Purity test date: Sept 10, 2001
- Lot/batch No.: 24773
- Expiration date of the lot/batch: No data
- Storage condition of test material: At room temperature in tightly closed container
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 33-43 d, females 44-56 d
- Weight at study initiation: Males 215-267 g and females 198-230 g at dosing
- Fasting period before study: 16 hours
- Housing: Single housing in Macrolon type III cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3
- Humidity (%): 55 +- 15
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From November 8, 2001 to December 10, 2001 (day of dosing to termination of in-life phase)
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal
- % coverage: 10
- Type of wrap if used: Gauze secured with adhesive plaster on the application site
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residues of test item (if any) were removed
- Time after start of exposure: 24 hours after administration
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.88 mL/kg bw
- Concentration (if solution): 13.3%, 40% in corn oil and undiluted
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- 250, 750, and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations 5, 15, 30, 60 min, and 3, 6, 24 h after application and then at least once daily; weighing once weekly
- Necropsy of survivors performed: yes
- Other examinations: skin was observed for erythema and oedema and rated - Statistics:
- LD50 calculated by means of regression analysis. The mortality rates at 24 hours and 14 days were used.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 790 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 after 14 days. No CL determined.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- >= 1 200 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 after 14 days. No CL determined
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 760 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 after 14 days. No CL determined
- Mortality:
- see Table for Acute Dermal Toxicity
- Clinical signs:
- other: 250 mg/kg bw: no local or systemic effects 750 mg/kg bw: no local effects but reduced motility, ataxia, dyspnoea in all animals, 1/5 males with slightly reduced muscle tone. 2000 mg/kg bw, systemic effects: like mid dose group with some augmentation; sl
- Gross pathology:
- No treatment-related findings at necropsy except local effects in the high dose group: severe necrosis in 2/5 females
Any other information on results incl. tables
Table for Acute Dermal Toxicity
Dose [mg/kg bw] |
Number of dead / |
Time of death (range) |
Observations |
250 |
males 0/5, females 0/5 |
|
See under Clinical signs |
750 |
males 0/5, females 1/5 |
day 1 |
|
2000 |
males 5/5, females 5/5 |
day 1-7 |
|
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 in Sprague-Dawley rats was calculated to be 1200 mg/kg bw for males and 760 mg/kg bw for females.
The dose dependency of observed effects was demonstrated. The test substance showed local and systemic effects. The test substance hydrolysis in contact with water to formaldehyde and 2-hydroxypropylamine. Effects may be mostly related to the hydrolysis product formaldehyde. - Executive summary:
Study according to OECD guideline 402. Five males and 5 females per dose were exposed to 250, 750, and 2000 mg/kg bw (13.3 and 40% in corn oil and undiluted, volume 1.88 mL/kg bw; semi-occlusive). Termination 14 days after dermal exposure.
LD50 after 14 days: 1200 mg/kg bw for males and 760 mg/kg bw for females. Classification: harmful
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