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EC number: 616-020-3 | CAS number: 7381-13-7
- 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 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study:
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 1,1'-(1,3-Phenylenedicarbonyl)diazepan-2-one
- EC Number:
- 616-020-3
- Cas Number:
- 7381-13-7
- Molecular formula:
- C20H24N2O4
- IUPAC Name:
- 1,1'-(1,3-Phenylenedicarbonyl)diazepan-2-one
- Details on test material:
- none
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle, France)
- Age at study initiation: 8 weeks
- Weight at study initiation: 185 g - 200 g
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 19 °C and 24°C
- Humidity (%): between 41 % and 59 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/kg body weight of the test item diluted in olive oil
MAXIMUM DOSE VOLUME APPLIED: volume of 10 mL/kg body weight - Doses:
- Group 2: 2000 mg/kg bw
Group 1: received, according to the same experimental conditions, the control item (distilled water) under a volume of 2 mL/kg body weight. - No. of animals per sex per dose:
- Graup 1 (contro]): 6 female rats;
Group 2 (treated - 2000 mg/kg): 3 female rats, 3 female rats - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Day 1 - Day 14
- Frequency of weighing: D0, D2; D7;D14
- Necropsy of survivors performed: yes - Statistics:
- n.a.
Results and discussion
- Preliminary study:
- n.a.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occnrred during the study.
- Clinical signs:
- No clinical signs related to the administration ofthe test item were observed.
- Body weight:
- The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.
- Gross pathology:
- The macroscopical examination of the animals at the end of the study did not reveal treatment-related
changes. - Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
The test item was administered to a group of 6 female Sprague Dawley rats at the single dose of 2000 mg/kg body weight. The experimental protoeol was established on the basis of the offieial method as defined in the O.E.C.D. guideline N° 423 dated December 17th, 2001 and the test method B.ltris ofthe Directive N° 2004/73/EC. No mortality oecurred during the study. No clinieal signs related to the administration of the test item were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopical examination of the animals at the end of the study did not reveal treatrnent-related ehanges. In eonclusion, the LD,o of the test item is higher than 2000 mg/kg body weight by oral route in the rat. According to the criteria for classification, paekaging and labelling of dangerous substanees and preparations in aceordance with the E.E.C. Directives 67/548, 2001159 and 99/45, the test item must not be classified. No symbol and risk phrase are required.
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