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EC number: 221-254-0 | CAS number: 3047-32-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study performed prior to adoption of the LLNA test method (OECD 429).
Test material
- Reference substance name:
- 3-ethyloxetane-3-methanol
- EC Number:
- 221-254-0
- EC Name:
- 3-ethyloxetane-3-methanol
- Cas Number:
- 3047-32-3
- Molecular formula:
- C6H12O2
- IUPAC Name:
- (3-ethyloxetan-3-yl)methanol
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Trimethylolpropane Oxetane.
- Physical state: Colourless liquid.
- Analytical purity: No information provided; treated as 100% pure.
- Purity test date: No information provided.
- Lot/batch No.: TT099-2
- Expiration date of the lot/batch: 31st December 1999
- Stability under test conditions: No information provided.
- Storage condition of test material: In a refrigerator in the dark.
- Other: Density: 1022 kg/m3.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Himalayan Strain albino guinea pig.
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland.
- Age at study initiation: Approximately 4 - 5 weeks old.
- Weight at study initiation: Less than 500 grams.
- Housing: Group housing of 5 animals per labelled metal cage with wire-mesh floors and equipped with an automatic drinking system.
- Diet (e.g. ad libitum): Free access to standard guinea pig diet, including ascorbic acid (1000mg/kg).
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark.
IN-LIFE DATES: From: To: No information provided.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
- Concentration / amount:
- 100% concentration
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
- Concentration / amount:
- 100% concentration
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
A preliminary study was conducted in order to select the test substance concentrations to be used in the main study. A series of test substance concentrations was used, with the starting concentration of 100% (undiluted) and subsequent concentrations taken from the series (50%, 20%, 10%, 5%, 2%, 1% and if needed, further lower concentrations using the same steps.
The test system, procedures and techniques were identical to those used in the main study, with animals between 4 and 9 weeks of age. Body weights may have exceeded 500 grams.
A series of 4 test substance concentrations was sued, the highest concentration being the maximum concentration that could technically be appled. Two different concentratiosn were applied (0.15ml each) per animal to the clipped flank using Metalline patches (2x3cm) mounted on Medical tape, which was held in place with Micropore tape and subsequently Coban elastic bandage. After 6 hours, the dressing were removed and the skin cleaned of residual test substance. The resulting dermal reactions were assessed for irritation 24 and 48 hours after exposure.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three exposures on days 1, 8 and 15.
- Exposure period: 6 hours exposure.
- Test groups: 0.5ml of undiluted test substance was applied epidermally using Metalline patches (2x3cm) mounted on medical tape which was held in place with Micropore tape and subsequently Coban elastic bandage. After 6 hours, the dressing were removed and the skin cleaned of residual test substance. Immediately after removal of the last induction application on day 15, the treated skin was assessed for irritation.
- Control group: The control animals were treated as described for the experimental animals except that vehicle alone was administered.
- Site: Left side of the scapular region.
- Frequency of applications: Days 1, 8 and 15.
- Duration: 6 hours
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: Single exposue on day 28.
- Day(s) of challenge: Day 28
- Exposure period: 6 hours.
- Test groups: The right flank of all animals was clipped and subsequently treated epidermally with the undiluted test susbtance and the vehicle (0.15ml of each), using patch test plasters. The patches were held in place with Micropore tape and subsequently with Covan elastic bandage. The dressings were removed after 6 hours and the skin cleaned of residual test substance and vehicle.
- Control group: Received same treatment as treated animals .
- Site: Right flank.
- Concentrations: 100%
- Evaluation (hr after challenge): The treated sites were assessed for challenge reactions 24 and 48 hours after removal of the dressings.
OTHER: - Challenge controls:
- All animals, including control, were treated epidermally with the undiluted test susbtance and the vehicle (0.15ml of each), using patch test plasters. The patches were held in place with Micropore tape and subsequently with Covan elastic bandage. The dressings were removed after 6 hours and the skin cleaned of residual test substance and vehicle.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No skin reactions were observed. No mortality occurred and no symptoms of systemic toxicity were observed in animals in the main study. Body weights and body weight gains were in the same range as controls over the study period.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No skin reactions were observed. No mortality occurred and no symptoms of systemic toxicity were observed in animals in the main study. Body weights and body weight gains were in the same range as controls over the study period. .
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Results as per 1st reading
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Results as per 1st reading.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Not applicable
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Not applicable
Any other information on results incl. tables
No additional information provided.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- There was no evidence that Trimethylolpropane Oxetane caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. Based on these results, Trimethylolpropane Oxetane is not sensitising to the skin.
- Executive summary:
The potential of Trimethylolpropane Oxetane to cause hypersensitivity was assessed in a skin sensitisation study conducted in accordance with OECD Test Guideline 406 and EC Commission 96/54/EEC, Part B.6, using the Buehler method. A preliminary study was conducted prior to the main study to ascertain the test substance concentrations. In the main study, 20 experimental animals were epidermally treated on three occasions (Days 1, 8 and 15) with undiluted test substance and ten control animals were similarly treated but with vehicle alone. Two weeks after the last induction exposure, all animals were challenged with the undiluted test substance and the vehicle.
No skin reactions were evident after the challenge exposure in the experimental animals or in the control animals. There was no evidence that Trimethylolpropane Oxetane caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. Based on these results, Trimethylolpropane Oxetane was nto found to be a skin sensitiser.
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