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EC number: 627-725-0 | CAS number: 398489-26-4
- 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:
- May - July 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Tert-butyl 3-oxoazetidine-1-carboxylate
- EC Number:
- 627-725-0
- Cas Number:
- 398489-26-4
- Molecular formula:
- C8H13NO3
- IUPAC Name:
- Tert-butyl 3-oxoazetidine-1-carboxylate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Batch Nr. : RC10050008
Purity : 99.44%
Retest date : 22 June 2013
Storage conditions : room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Doses:
- 300 and 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 500 mg/kg bw
- Based on:
- test mat.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- According to OECD test guideline 423 the acute oral median lethal dose (LD50) of PAM-Azetidinone, CAS No. 398489-26-4 in the female Wistar rat
was estimated to be 2500 mg/kg body weight (Globally Harmonized Classification System - Category 5, > 2000 - 5000 mg/kg body weight). - Executive summary:
Introduction
The study was performed to assess the acute oral toxicity of the PAM-Azetidinone in the Wistar strain rat.
Methods
A group of three fasted females was treated with the test item at a dose level of 300 mg/kg body weight. Based on the results from this dose level, further groups of fasted females were treated at a dose level of 2000 mg/kg body weight. Dosing was performed sequentially.
The test item was administered orally as a solution in dimethyl sulphoxide. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
Results
Mortality.
One animal treated at a dose level of 2000 mg/kg was killed for humane reasons, during the day of dosing, due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence. There were no deaths at a dose level of 300 mg/kg.
Clinical Observations.
Signs of systemic toxicity noted in animals treated at a dose level of 2000 mg/kg were hunched posture, ataxia and pilo-erection. Additional signs of systemic toxicity noted in one animal treated at a dose level of 2000 mg/kg were prostration, labored respiration, decreased respiratory rate and coma. There were no signs of systemic toxicity noted in the initial three animals treated at a dose level of 2000 mg/kg and animals treated at a dose level of 300 mg/kg.
Body Weight.
Surviving animals showed expected gains in body weight.
Necropsy.
Abnormalities noted at necropsy of the animal that was humanely killed were yellow colored liquid present in the stomach and haemorrhage and epithelial sloughing of the gastric mucosa. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
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