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EC number: 231-810-4 | CAS number: 7747-35-5
- 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:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD guideline 406 and in accordance with GLP
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Remarks:
- Not specified in the report.
- Principles of method if other than guideline:
- Following OECD guideline 406
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 7a-ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole
- EC Number:
- 231-810-4
- EC Name:
- 7a-ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole
- Cas Number:
- 7747-35-5
- Molecular formula:
- C7H13NO2
- IUPAC Name:
- 7a-ethyl-tetrahydro-1H-[1,3]oxazolo[3,4-c][1,3]oxazole
- Details on test material:
- - Name of test material (as cited in study report): Oxaban E (BIOBANTM CS-1246 Antimicrobial)
- Physical state: Clear colorless liquid
- Storage condition of test material: Stored at room temperature throughout the study ina clear glass bottle.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Not specified although noted to be obtained from a U.S.D.A.-approved supplier
- Age at study initiation:
- Weight at study initiation: 368 - 689 grams
- Housing: Housed individually in wire mesh suspension cages
- Diet (e.g. ad libitum): Purina guinea pig chow fed ad libitum
- Water (e.g. ad libitum): Tap water provided ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Standard conditions
- Humidity (%): Standard conditions
- Air changes (per hr): Standard conditions
- Photoperiod (hrs dark / hrs light): 12/12 cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Induction:
5% Injection application
25% Tropical application
Challenge:
Tropical application: 1%
Rechallenge:
Tropical application: 0.2, 0.01 and 0.001%
50%(V/V)
Injection Application: 5%
Tropical application: 25%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction:
5% Injection application
25% Tropical application
Challenge:
Tropical application: 1%
Rechallenge:
Tropical application: 0.2, 0.01 and 0.001%
50%(V/V)
Injection Application: 5%
Tropical application: 25%
- No. of animals per dose:
- Twenty test animals, 10 niave controls, 10 vehicle controls, 10 positive controls, 10 naive positive controls, 8 animals for topical application screens, and 4 intradermal injection pilots were used during the course of the study.
- Details on study design:
- Twenty test animals, 10 naive controls, 10 vehicle controls, 10 positive controls, 10 naive positive controls, 8 animals for topical application screens, and 4 intradermal injection pilots were used during the course of the study.
Animals were recieved from a commercial supplier, and were quarantined for at least 4 days prior to use. They were housed singly in wire caging, and were provided water and a commercial diet ad libitum. They were housed in rooms designed to maintain adequate environmental conditions for the species.
The study was conducted in 4 phases: irritation, intradermal induction, topical induction, and challenge. Irritation screens were accomplished by intradermally injecting varying concentrations of the test material in the selected solvent in paired rows on either side of the midline of the animal, or by applying the materials to a patch, and affixing the patch to the skin. Test sites were evaluated 24 hours later. The concentration selected for injection is one that does not cause tissue destruction, and is only mildly to moderately irritating. The challenge concentrations were no more than slightly irritating. Intradermal induction was accomplished by exposing the animals to a solution of the test material (or positive or negative control) and Freunds Complete Adjuvant (FCA). Volumes of 0.1mL were delivered to a cleanly-shaven test site in two rows of three injections on either side of the midline. Eight days later, topical inductions were performed by adding the materials to the patch, and covering for 48 hours. The wrappings were removed, skin sites cleaned and evaluated. Primary topical challenge was conducted 11-15 days after the topical induction in the same manner. Wrappings were removed after 24 hours, and sites evaluated. Six days after the first challenge, some animals may be challenged a second time in the same manner as the first topical challenge. - Challenge controls:
- None
- Positive control substance(s):
- yes
- Remarks:
- Formaldehyde 5% w/v in distilled water
Study design: in vivo (LLNA)
- Concentration:
- Not applicable
- No. of animals per dose:
- Not applicable
- Details on study design:
- Not applicable
- Statistics:
- Primary irritation skin grades were used to derive at the toxicity data.
Results and discussion
- Positive control results:
- Positive control produced a 100% sensitization rate.
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
None
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material is considered to be a sensitizer in this system.
- Executive summary:
Twenty test animals, 10 niave controls, 10 vehicle controls, 10 positive controls, 10 naive positive controls, 8 animals for topical application screens, and 4 intradermal injection pilots were used during the course of the study.
Animals were recieved from a commercial supplier, and were quarantined for at least 4 days prior to use. They were housed singly in wire caging, and were provided water and a commercial diet ad libitum. They were housed in rooms designed to maintain adequate environmental conditions for the species.
The study was conducted in 4 phases: irritation, intradermal induction, topical induction, and challenge. Irritation screens were accomplished by intradermally injecting varying concentrations of the test material in the selected solvent in paired rows on either side of the midline of the animal, or by applying the materials to a patch, and affixing the patch to the skin. Test sites were evaluated 24 hours later. The concentration selected for injection is one that does not cause tissue destruction, and is only mildly to moderately irritating. The challenge concentrations were no more than slightly irritating. Intradermal induction was accomplished by exposing the animals to a solution of the test material (or positive or negative control) and Freunds Complete Adjuvant (FCA). Volumes of 0.1mL were delivered to a cleanly-shaven test site in two rows of three injections on either side of the midline. Eight days later, topical inductions were performed by adding the materials to the patch, and covering for 48 hours. The wrappings were removed, skin sites cleaned and evaluated. Primary topical challenge was conducted 11-15 days after the topical induction in the same manner. Wrappings and excess test material were removed after 24 hours, and sites evaluated. Six days after the primary challenge, some animals were challenged a second time in the same manner as the first topical challenge.The induction/challenge test at 0.001% was considered to have elicited a mild sensitization response.
The induction/challenge test at 0.01% was considered to have elicited a moderate sensitization response.
The induction/challenge test at 0.2% was considered to have elicited a strong sensitization response.
The induction/challenge test at 1% was considered to have elicited an "extreme" sensitization response.
Distilled water elicited a 0% sensitization rate, while the positive control produced a 100% sensitization rate.The test material was determined to be a dermal sensitizer in guinea pigs.
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