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EC number: 700-012-2 | CAS number: 950919-28-5
- 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:
- From January 15 to February 10, 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline 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 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- Adopted 8th February 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Compliance Programme (inspected on August 19, 2008/ signed on March 04, 2009)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 7-(propan-2-yl)-3,4-dihydro-2H-1,5-benzodioxepin-3-one
- EC Number:
- 700-012-2
- Cas Number:
- 950919-28-5
- Molecular formula:
- C12H14O3
- IUPAC Name:
- 7-(propan-2-yl)-3,4-dihydro-2H-1,5-benzodioxepin-3-one
- Test material form:
- solid
- Remarks:
- paste / solid block
- Details on test material:
- - Physical state: solid, pale yellow to yellow block, or pasty
- Stability under test conditions: no data
- Storage condition of test material: in the dark, preferably at about 4-10°C and under nitrogen.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 187-219 g
- Fasting period before study: Animals were fasted for overnight period before test item administration and for approximately 3-4 h after dosing.
- Housing: Animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: Food (2014 Teklad Global Rodent diet supplied by Harlan Teklad, Bicester, Oxon, UK), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: 15 changes / h
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: From: January 15, 2009 To: February 10, 2009
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL
- Justification for choice of vehicle: Test material was not dissolved/suspended in distilled water, therefore arachis oil was selected as vehicle.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION:
- Test material was freshly prepared, as required, as a suspension in arachis oil BP. - Doses:
- - Sighting study: 300 and 2000 mg/kg bw
- Main study: 300 mg/kg bw - No. of animals per sex per dose:
- - Sighting study: 1 female/dose
- Main study: 5 females/dose (One animal from sighting study and 4 additional animals) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations were made 0.5, 1, 2 and 4 h after dosing and then daily for 14 days. Morbidity and mortality checks were made twice daily. Body weight of each animal was recorded on Day 0 (the day of dosing) and on Days 7 and 14 or at death.
- Necropsy of survivors performed: Yes; on completion of the observation period, animals were killed by cervical dislocation and subjected to gross necropsy. - Statistics:
- None
Results and discussion
- Preliminary study:
- - There were no deaths or clinical signs of toxicity at a dose level of 300 mg/kg bw.
- Animal treated at a dose level of 2000 mg/kg bw was killed in extremis approximately 2 h after dosing.
- Signs of systemic toxicity noted in animal treated with 2000 mg/kg bw were hunched posture, ataxia, lethargy, pilo-erection, decreased respiratory rate, laboured respiration and hypothermia. The animal was comatose approximately 2 h after dosing.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: One animal was found dead at 2000 mg/kg bw
- Mortality:
- - No mortality was observed at a dose level of 300 mg/kg bw.
- Clinical signs:
- - No signs of systemic toxicity were noted during the observation period at 300 mg/kg bw.
- Body weight:
- - All animals showed expected gains in bodyweight over the 14 day study period at 300 mg/kg bw.
- Gross pathology:
- - No abnormalities were noted at necropsy.
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the test conditions, the oral LD50 for the registered substance is 300 < Oral LD50 ≤2000 mg/kg bw in female rats, therefore the test material is classified as ‘Category 4’ according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS. Based on narcotic effects observed at the dose level of 2000 mg/kg bw, the test material is classified as a specific target organ toxicant after single exposure, H336: May cause drowsiness or dizziness according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In an acute oral toxicity study performed according to OECD Guideline No. 420 and in compliance with GLP, female Wistar (HsdRccHan®™:WIST™) rats were administered a single oral dose of test material by gavage.
Following a sighting study using one animal at a dose level of 300 and 2000 mg/kg bw, additional four animals were administered a single oral dose of test item at 300 mg/kg bw (main study). Animals were then observed for mortality, clinical signs and bodyweight development for 14 days and at the end of the study the surviving animals were subjected to macroscopic examination.
The animal treated at a dose level of 2000 mg/kg bw was killed in extremis approximately two hours after dosing. Signs of systemic toxicity noted in animal treated with 2000 mg/kg bw were hunched posture, ataxia, lethargy, pilo-erection, decreased respiratory rate, laboured respiration and hypothermia. Animal was comatose approximately two hours after dosing.
No mortality or clinical signs were observed at 300 mg/kg bw. All animals showed expected gains in bodyweight over the 14 day study period. No abnormalities were noted at necropsy.
300 < Rat Oral LD50 (females) ≤2000 mg/kg bw
Under the test conditions, the test material is classified as ‘Category 4’ according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS. Based on narcotic effects observed at the dose level of 2000 mg/kg bw, the test material is classified as a specific target organ toxicant after single exposure, H336: May cause drowsiness or dizziness according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
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