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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD guideline 402 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:
- 2 009
- Report date:
- 2009
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:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Principles of method if other than guideline:
- Guideline followed
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
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): Bioban TMCS-1246
- Molecular formula (if other than submission substance): C7H13NO2
- Molecular weight (if other than submission substance): 143.09
- Physical state: Clear Liquid
- Analytical purity: 98.7% ± 0.01%
- Lot/batch No.: TC1031LAH3
- Stability under test conditions: Not reported, assumed to be stable under normal storage conditions
- Storage condition of test material: +18 to +36 Deg. C
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Inhouse Bred
- Age at study initiation: 12 weeks
- Weight at study initiation: Males: 277.44 to 287.10 g
Female: 209.97 to 227.95 g
- Fasting period before study:
- Housing: Housed individually in standard polysulfone cages, with stainless steel top grill having facilities for pelleted food and drinking water.
- Diet (e.g. ad libitum): Mice pellet food ad libitum
- Water (e.g. ad libitum): Deep bore-well purified water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23 deg.C
- Humidity (%): 65 to 67 %
- Air changes (per hr): 12 to 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsolateral thoracic surface
- % coverage: 10%
- Type of wrap if used: cotton gauze
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiped with water using clean towels
- Time after start of exposure: 24 hrs
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg body weight (1.85ml/kg body weight)
- Concentration (if solution): Undiluted test substance
VEHICLE
- Amount(s) applied (volume or weight with unit): Undiluted test substance used (No vehicle used) - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight (1.85 ml/kg body weigh)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
The acute dermal toxicity of Bioban TMCS-1246 was tested in male and female Wistar rats. The test was conducted using 10 rats, 5 males and 5 females. Approximately 24 hours prior to treatment, the hair on the dorso lateral thoracic surface of the skin was clipped (approximately 8 x 10 cm). Doses were calculated based on individual body weight, the undiluted test substance at the dose of 2000 mg/kg body weight (A volume of 1.85 mL/kg body weight) was applied directly to the prepared skin of the animal and covered with a cotton gauze and secured in position by non-allergenic surgical tape wound around torso. The test substance contact period with the skin was for 24 hours.
After the 24-hour contact period, the patches were removed and the application site was wiped with water using clean towels to remove any residual test substance.
Clinical observations, body weights and local skin reactions were recorded. At the end of the 14 day observation period, all rats were euthanised by using isoflurane anaesthesia. External surface of the body, all orifices, tissues and organs of the thoracic and abdominal cavities of all animals were examined. All findings were recorded. - Statistics:
- None
Results and discussion
- Preliminary study:
- An initial dose of 2000mg/kg body weight (1.85 ml/kg body weight) was applied to 5 female rats. There was no test substance related mortality observed.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no test substance related mortality observed.
- Clinical signs:
- other: The clinical / toxic signs observed were hypersensitive response to handling in five female rats at 30 minutes after application, and at 1 hour and 2 hours in both male and female rats and it persisted in two female rats (Rb8503 and Rb8505) at 3'* hour po
- Gross pathology:
- There was no abnormality detected at necropsy.
- Other findings:
- There were no local skin reactions observed at the site of application.
Any other information on results incl. tables
Refer attachment: Table1. Body weight, body weight Changes and Pre-Treatment deaths
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results, it can concluded that the acute dermal LD50 of Bioban TMCS-1246 is greater than the limit dose of 2000 mg/kg body weight in male and female rats.
- Executive summary:
The acute dermal toxicity of BiobanTMCS-1246 was tested in male and female Wistar rats following OECD Guideline for Testing of Chemicals, No. 402; OPPTS 870.1200 (1 998) and European Communities. Methods for theDetermination of Toxicity, Part B.3.
The test was conducted using 10 rats, 5 males and 5 females. Approximately 24 hours prior to treatment, the hair on the dorso lateral thoracic surface of the skin was clipped (approximately 8 x 10 cm). Doses were calculated based on individual body weight, the undiluted test substance at the dose of 2000mg/kg body weight (A volume of 1.85 mL/kg body weight) was applied directly to the prepared skin of the animal and covered with a cotton gauze and secured in position by non-allergenic surgical tape wound around torso. The test substance contact period with the skin was for 24 hours.
After the 24-hour contact period, the patches were removed and the application site was wiped with water using clean towels to remove any residual test substance.
Clinical observations, body weights and local skin reactions were recorded. At the end of the 14 day observation period, all rats were euthanised by using isoflurane anaesthesia. External surface of the body, all orifices, tissues and organs of the thoracic and abdominal cavities of all animals were examined. All findings were recorded.
The toxic signs observed were hypersensitive response to handling at 30 minutes to 3 hours in female rats, and at 1stand 2nd hour in male rats and all the male rats were normal from 3rdhour and all the female rats were normal from 4thhour post application period onwards. There were no local skin reactions observed and no pre-terminal deaths. All rats gained body weight through the observation period. There were no abnormalities detected at necropsy.
Based on the above results, it is concluded that the acute dermal LD50 of BiobanTMCS-1246 is greater than the limit dose of 2000 mg/kg body weight in male and female rats.
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