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EC number: 837-106-9 | CAS number: 71472-57-6
- 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:
- 2nd April 2019 - 24th April 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 6-methyl-3,4-dihydro-2H-1,4-benzoxazine
- EC Number:
- 837-106-9
- Cas Number:
- 71472-57-6
- Molecular formula:
- C9H11NO
- IUPAC Name:
- 6-methyl-3,4-dihydro-2H-1,4-benzoxazine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Purity: >99% (by HPLC area % 225 nm bandwidth 50 nm)
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V., Inc, Postbus 6174, 5960 AD Horst / The Netherlands
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 7 - 12 weeks
- Weight at study initiation: 166.9 - 187.1g
- Fasting period before study: The animals were fasted over night before treatment, with constant ad libitum access to drinking water.
- Housing: groups of one to five rats (of the same sex and dose group)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days prior to the start of dosing under test conditions after health examination
ENVIRONMENTAL CONDITIONS
temperature 22 + 2°C
relative humidity approx. 45-65
(with the aim of 50 – 60%)
artificial light 6.00 a.m. - 6.00 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30mg/mL (300 mg/kg)
- Amount of vehicle (if gavage): The volume administered did not exceed 10 mL/kg b.w - Doses:
- 300 and 2000 mg/kg
- No. of animals per sex per dose:
- 1 at each selected dose level in prelim study (300 and 2000 mg/kg)
4 at the maximum tolerated dose (300 mg/kg) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least three times within the first six hours after application (i.e., 30 minutes and 1 hour, 2 hours and 4 hours after dosing), thereafter at least once daily for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Not specified
Results and discussion
- Preliminary study:
- mortality and signs of systemic toxicity at a dose level of 2000 mg/kg
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 300 - <= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths during the study at 300mg/kg.
The female (2000m/kg) used in the sighting test had to be humanely sacrificed an hour after treatment. - Clinical signs:
- other: 300 mg/kg b.w: Closed eyes to partly closed eyes, hunched posture, lachrymation, piloerection, decreased activity, and staining of the urine (orange) were noted within 6 hours of dosing in the animals treated at a dose level of 300 mg/kg.These signs were
- Gross pathology:
- Macroscopic examination at study termination on Day 14 revealed the spleen of animal 4 was swollen. The stomach of animal 1 and 4 smelled sourly. The thymus of animal 3 was speckled red. No abnormalities were noted in animals 2 and 5 at the macroscopic examination.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of the test substance was demonstrated to be between 300 and 2000 mg/kg body weight.
The substance is included in Category 4, according to the Globally Harmonised System (GHS). - Executive summary:
The study was performed to assess the acute oral toxicity of 6 -methyl-3,4 -dihydro-2H-1,4 -benzoxazine to the rat.
Methods
Following two sighting tests at dose levels 300 mg/kg b.w. and 2000 mg/kg b.w. in one female rat per dose group, a further group of fourfasted females was given a single oral dose of the test substance as a solution in corn oil at a dose level of 300 mg/kg body weight. Clinical signs and body weight development were monitored in all animals during the study. All animals were subjected to gross necropsy.
Results
Mortality: There were no deaths at dose level 300 mg/kg b.w.. The animal of the sighting test at 2000 mg/kg b.w., was humanely sacrificed 1h after the application.
Clinical Observations: Closed eyes or partially closed eyes, hunched posture, lachrymation, piloerection, decreased activity, hypothermia, and orange staining of the urine were noted within 6 hours of dosing in the animals treated at a dose level of 300 mg/kg.
In the one animal treated at 2000 mg/kg b.w. closed eyes to partially closed eyes, lachrymation, apathy, decreased respiration rate, and prostration were observed within the first hour after dosing. Additionally, the animal was moribund and unconscious. Therefore, the animal was humanely sacrificed.Body Weight: All animals showed expected gains in body weight.
Necropsy: The spleen of animal 4 was swollen. The stomach of animal 1 and 4 smelled sourly. The thymus of animal 3 was speckled red.
Conclusion
The acute median lethal oral dose (LD50) to rats of the test substance was demonstrated to be between 300 and 2000 mg/kg body weight.
The substance is included in Category 4 according to the Globally Harmonised System (GHS).
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