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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Guideline study, well reported and documented according to good scientific standards
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
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'-methylenebisoxazolidin/CAS-Nr. 66204-44-2
- Substance type: Reaction product from paraformaldehyde and 2 hydroxypropylamine (ratio of 3:2)
- Physical state: Clear colourless liquid
- Analytical purity: Activity > 99%
- Lot/batch No.: 24773
- Expiration date of the lot/batch: July 2002
- Storage condition of test material: At room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Little Russians, albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BI Pharma KG, D88397 Biberach
- Weight at study initiation: 2.5-2.8 kg
- Housing: Individually in PPO cages with perforated floor
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3
- Humidity (%): 55 +-15
- Air changes (per hr): 10 times
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From November 19, 2001 to December 18, 2001
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- Exposure period was 4 hours
- Observation period:
- Post-exposure period was 28 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal area of the trunk
- % coverage: 10 cm x 10 cm
- Type of wrap if used: Gauze pads which were secured with adhesive Gothaplast® tape and further fixed with Gothaplast® tape wound around the trunk
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4hours
SCORING SYSTEM: Comparable to OECD 404 scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- >= 3.2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Day 28: scarring in two animals, one rabbit free of any signs of skin irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- >= 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: Day 28: scarring in two animals, one rabbit free of any signs of skin irritation
- Irritant / corrosive response data:
- The mean scores for erythema and oedema are ≥ 2.0 at all reading times. Destruction of skin tissue was observed, the effects were not reversible: day 7 brown discolouration, necrotic tissue, demarcation in 2 rabbits; day 14 brown discolouration and demarcation or red coloured tissue with scales or red coloured tissue with scales plus necrotic tissue; day 21 2 animals with granulation tissue, one animal with intact skin; day 28 scarring in two animals, one rabbit free of any signs of skin irritation.
Any other information on results incl. tables
Table for skin irritation study
|
time after start of exposure |
Erythema |
Edema |
average Draize scores of 3 rabbits |
1 h |
2.8# |
4.0 |
24 h |
2.5 |
2.0 |
|
48 h |
3.2## |
2.0 |
|
72 h |
4.0## |
2.0 |
|
reversibility: |
No |
No |
|
#: brown discolouration in one animal (## in 2 animals) |
|
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- The test substance is corrosive. According to EEC directive 98/98/EC the test substance shall be classified as “causes burns”.
- Executive summary:
Study according to OECD guideline 404. 3 rabbits exposed to 0.5 mL undiluted test substance for 4 hours. According to EEC Directive 98/98/EC the test substance shall be classified as “causes burns”. There was no complete reversibility after 28 days.
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