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Diss Factsheets
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EC number: 455-560-2 | CAS number: -
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- 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:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed concentration procedure
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- liquid
- Specific details on test material used for the study:
- Lot number 0905513112, Purity 98.4 %
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Healthy young adult Sprague-Dawley rats were received from Vital River Laboratories. At experiment initiation, the animals were 8-12 weeks of age. The animals were acclimatized to the animal room conditions for at least 5 days. At the study start the variation of individual weights did not exceed 10% of the mean for each sex. Animals were identified by individual color-marking and cage cards. Cage cards displaying at least the study number, animal number and sex were affixed to each cage. Housing was in plastic cages of appropriate sizes with stainless steel wire cover and chopped wood bedding. All animal rooms were maintained under a 12h light-dark cycle with temperature ranging from 23-25 oC, and relative humidity of between 30-70 % throughout this study. During the acclimatization and study periods the animals were housed in Animal Center of New Drug Safety Evaluation Center in Chinese Academy of Medical Sciences & Peking Union Medical College. Standard pelleted rat feed (Animal Center Military Medical Science Academy) was provided ad libitum to the animals throughout the study. Municipal tap water treated by reverse osmosis was available ad libitum throughout the study.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- not specified
- Remarks:
- noted as aerosolized without the use of any additional vehicle
- Mass median aerodynamic diameter (MMAD):
- 1.77 µm
- Geometric standard deviation (GSD):
- 1.77
- Remark on MMAD/GSD:
- MMAD +/- 0.02 um
GSD +/- 0.1 - Details on inhalation exposure:
- Aerosol was generated by a aerosol generator (TSI, 8108, USA). The samples for the analysis of aerodynamic particle-size distribution were taken in the vicinity of the breathing zone. The particle-size distribution was analyzed using a aerodynamic particle-sizer Spectrometer (TSI, 3321, USA).
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- target 5000 mg/L
actual 5112+/-117 - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Observations:
Cage-side observations included changes in the skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behavior patterns. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, lethargy, somnolence and prostration.
Body weight:
Body weight were measured once during the acclimatization period, on the day of exposure prior to exposure (day 0), and at least on days 1, 3 and 7, and weekly thereafter.
Gross Necropsy:
All rats, irrespective of the day of death, were given a gross pathological examination. Consideration was given to performing a gross necropsy on animals as indicated by the nature of toxic effects, with particular reference to changes related to the respiratory tract. All gross pathological changes were recorded and evaluated.
Temp. 21.7 oC; humidity 47 %, airflow 5 L/min - Statistics:
- Data from the limit test were analyzed and an LC50 value estimated as follows:
< 50% Mortality: LC50 was estimated as greater than the administered dose.
= 50% Mortality: LC50 was estimated as equal to the administered dose.
> 50% Mortality: LC50 was estimated as less than the administered dose.
Body weight means and standard deviations were calculated separately for males and females for each limit level administered.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- >= 5 112 mg/m³ air (analytical)
- Based on:
- test mat.
- 95% CL:
- 117
- Exp. duration:
- 4 h
- Mortality:
- none
- Clinical signs:
- other: The most notable clinical abnormalities observed during the exposure included rough coat, nasal secretions, salivation, tremors. These clinical abnormalities were observed on the day 0 of exposure, but then disappeared after 24h
- Body weight:
- A slight body weight loss was noted for the male rats at day 1, and for female rats at day 1 and 3. Normal body weight gain resumed for all other animals after that.
- Gross pathology:
- No significant gross internal findings were observed at necropsy on study day 14.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute inhalation LC50 of 3,3,5,7,7-pentamethyl-1,2,4-trioxepane was estimated to be greater than 5112 mg/m3 in the rat.
- Executive summary:
The acute inhalation LC50 of 3,3,5,7,7-pentamethyl-1,2,4-trioxepane was estimated to be greater than 5112 mg/m3 in the rat. Data are consclusive but not sufficient for classification.
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