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EC number: 425-660-0 | CAS number: 165101-57-5
- 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:
- 1995-11-10 to 1995-11-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- July 17th 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- July 31st 1992
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 425-660-0
- EC Name:
- -
- Cas Number:
- 165101-57-5
- Molecular formula:
- C14H29NO
- IUPAC Name:
- 3-butyl-2-(heptan-3-yl)-1,3-oxazolidine
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: Charles River (UK) Ltd
- Weight at study initiation: male: 201-283 g; female: 165-190 g
- Fasting period before study: approximately 18 hours prior to dosing until 3 hours after dosing
- Housing: five animals per sex in suspended stainless steel mesh cages (dimensions 55 x 34 x 20 cm)
- Diet (e.g. ad libitum): SQC(E) Rat and Mouse Maintenance Diet No 1, ad libitum
- Water (e.g. ad libitum): mains water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- dessicated
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/kg bw
- Amount of vehicle: 10 mL/kg bw
- Lot/batch no.: 11362
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- five animals/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once within one-half hour of dosing, four times within four hours of dosing, twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
- body weight: was done on day -1 (day before dosing), day 1 (day of dosing), day 8 and day 15 - Statistics:
- NA
Results and discussion
- Preliminary study:
- The preliminary study was undertaken to allow selection of the discriminating dose level for the main study. The discriminating dose level is the highest of four dose levels (5, 50, 500 or 2000 mg/kg) that is non-lethal in the main study. The preliminary investigation was conducted using groups of two fasted female rats dosed at 500 or 2000 mg/kg body weight.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animal died following single oral administration of Incozol 2 at 2000 mg/kg body weight.
- Clinical signs:
- other: There were no overt signs of reaction to treatment.
- Gross pathology:
- No macroscopic changes were apparent during necropsy of rats killed on day 15.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral toxicity study on Sprague-Dawley rats treated with Incozol 2 resulted in a LD50 of above 2000 mg/kg bw.
- Executive summary:
This study was conducted to assess the acute oral toxicity of Incozol 2 in the rat (Sprague-Dawley). The method followed was in compliance with Method B.1 bis and OECD TG 420. Five male and five female fasted rats were given the test item as a single dose by oral gavage at the limit dose level of 2000 mg/kg body weight. The test item was dispersed in corn oil and administered at a dose volume of 10 mL/kg bw on day 1. All animals were killed on day 15 and subsequently underwent a full necropsy. No animal died. There were no overt signs of reaction to treatment. All rats achieved body weight gains during the first and second week of the study. No macroscopic changes were apparent during necropsy of rats killed on day 15. The acute oral minimum lethal dose of Incozol 2 to rats was found to exceed 2000 mg/kg body weight (Corning Hazleton, 1995).
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