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EC number: 296-417-2 | CAS number: 92671-67-5
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Oct. 2000 - Febr. 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The accordance of the study with its protocol, the OECD Guideline 401 and the Principles of Good Laboratory Practice (GLP) is guaranteed.
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:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 1,5-dihydro-3-isopropyl-8-methyl-[1,3]dioxepino[5,6-c]pyridin-9-yl acetate
- EC Number:
- 296-417-2
- EC Name:
- 1,5-dihydro-3-isopropyl-8-methyl-[1,3]dioxepino[5,6-c]pyridin-9-yl acetate
- Cas Number:
- 92671-67-5
- Molecular formula:
- C14H19NO4
- IUPAC Name:
- 8-methyl-3-(propan-2-yl)-1H,3H,5H-[1,3]dioxepino[5,6-c]pyridin-9-yl acetate
- Details on test material:
- Substance type: Intermediate
- Physical state: solid
- Analytical purity: not stated
- Impurities (identity and concentrations): not specified
- Lot/batch No.:
- Expiration date of the lot/batch: not stated
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Other:
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstr. 27, D-33178 Borchen
- Fasting period before study: food was withheld overnight before the day of administration
- Housing: the rats housed individually in Makrolon cages (800 cm^2, height 17 cm)
- Diet (e.g. ad libitum): twice, 8 g daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 -25 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: 5 days
Administration / exposure
- Route of administration:
- other: diluted in vehicle
- Vehicle:
- ethanol
- Details on oral exposure:
-
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
- Doses:
- Group I (10 rats, 5 males and 5 females) 2000 mg/kg applied
Group II (5 rats, 5 females) 1333 mg/kg applied
Group III (5 rats, 5 females) 890 mg/kg applied
Group IV (5 rats, 5 females) 590 mg/kg applied
Group V (5 rats, 5 males) 1333 mg/kg applied - No. of animals per sex per dose:
- see above - doses
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days (or other?) 15 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- not relevant
Results and discussion
- Preliminary study:
- no preliminary study
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 850 mg/kg bw
- Mortality:
- The following times of death after administration of Isobutyralacetat were recorded:
2000 mg/kg: 4 of 10
1333 mg/kg: 0 of 10
890 mg/kg: 2 of 5
590 mg/kg: 1 of 5 - Clinical signs:
- disturbance of coordination with hyperactivity,
lateral position, strong spasm, pain screaming, therefore euthanasia for human reasons,
ruffled fur, hard breathing, diarrhoea, severe apathy, hunched posture - Body weight:
- no specific findings
- Gross pathology:
- The post-mortem findings did not show any macroscopic organ changes
- Other findings:
- no other findings
Any other information on results incl. tables
no additional remarks
Applicant's summary and conclusion
- Interpretation of results:
- other: categorie V GHS
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Isobutyralacetate needs not to be classified neighter according to 67/548/EEC nor 1272/2008/EEC. Category 5 has to be selected according to OECD GHS
- Executive summary:
The test substance dissolved in diluted absolute ethanol was administered orally in two doses within less than 3 hours to five groups of Sprague Dawley rats:
Group I (l0 rats, 5 males and 5 females) 2000 mg/kg applied
Group II (5 rats, 5 females) 1333 mg/kg applied
Group III (5 rats, 5 females) 890 mg/kg applied
Group IV (5 rats, 5 females) 590 mglkg applied
Group V (5 rats, 5 males) 1333 mg/kg applied
Isobutyralacetat, a solid, was dissolved immediately prior to administration in pure ethanol. Therefore, Group VI demonstrates the inoffensiveness of administrating ethanol: Group VI (4 rats, 2 males and 2 females)
Acute toxicological synlptoms attributed to the exposure to Isobutyralacetat could be observed in 4
out of ten rats dosed with 2000 mg/kg, in 0 rats out of 10 dosed with 1333 mg/kg, in 2 out of 5 rats
dosed with 890 mg/kg and in 1 out of 5 rats dosed with 590 mg/kg. The post-mortem findings did
not show any macroscopic organ changes. The LD50 value of Isobutyralacetat was determined to
2824 mg/kg for the female sex according to Probit Analysis.
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