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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The assay is comparable to OECD guideline 406 with some restrictions concerning documentation (e.g. no individual test results). No readings after 24 h but clearly positive results after 48 h. No GLP study.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 084
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no readings at 24 hours
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- former test strategy for skin sensisation, more animals are tested compared to LLNA
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): Grotan OX
- Substance type: Formaldehyde releaser
- Physical state: Liquid
- Composition of test material, percentage of components: Reaction product from paraformaldehyde and 2 hydroxypropylamine (ratio of 3:2) )
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Copenhagen: Statens Serum Institute, Denmark. Stockholm: J.A. Sahlin, Malmö, Sweden
- Diet: ad libitum:
- Water: ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-22
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: petrolatum
Challenge
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: petrolatum
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS: Results are not presented but authors stated that moderate irritant concentrations for induction (intradermal and topical) and a non-irritant concentration for challenge were established.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: Day 0 (intradermal) and Day7 (dermal)
- Test groups: 3
- Control group: 1
- Site: back/flank
- Frequency of applications: 1 intradermal, 1 dermal
- Duration:
- Concentrations: 0.5% in water for intradermal injection and 10% in water for topical induction (causing moderate irritation)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: no data about exposure duration but presumably 24 h as suggested in Magnuson & Kligman (1970)
- Test groups: 1
- Control group: 1
- Site: back
- Concentrations: 0.1, 0.5 and 1%
- Evaluation (hr after challenge): 48
OTHER: - Positive control substance(s):
- yes
- Remarks:
- Concurrently also other formaldehyde releasers were tested which gave positive results
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.0%
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Clinical observations:
- mean response: grade 1.12 erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.0% . No with. + reactions: 12.0. Total no. in groups: 20.0. Clinical observations: mean response: grade 1.12 erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- mean response: grade 1.12 erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: mean response: grade 1.12 erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- mean response: grade 1.12 erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: mean response: grade 1.12 erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- Strong sensitizer
- Executive summary:
The assay is comparable to OECD guideline 406 with some restrictions concerning documentation. No readings after 24 h but clearly positive results after 48 h.
Guinea pig maximisation test (GPMT); 20 animals per group; induction: 0.5% in water for intradermal injection and 10% in water for topical application (causing moderate irritation); challenge: 0.1, 0.5 or 1% in petrolatum (no irritation).Sensitising effects in 60% of test animals at a 1.0% concentration. Test item is a strong sensitizer.
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