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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12th August 2020 - 17th August 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Prior to undertaking in-vivo irritation testing the Study Director conducted a weight-of-evidence analysis, to ensure that the in-vivo testing was sufficiently justified. This study was conducted as both in-vitro studies were inconclusive. Eye (Bovine, OECD 437): no prediction; Eye (EpiOcular Test): borderline.
For classification purposes an in vivo study was conducted.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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:
- Chemical Name: 6-methyl-3,4-dihydro-2H-1,4-benzoxazine
CAS number: 71472-57-6
Intended use: Industrial chemical
Appearance: Light yellow liquid
Storage conditions: 2 to 8°C, protected from light. Kept in storage container under protective atmosphere.
Supplier: Sponsor
Batch number: AMRI-1394906005
Expiry date: 01 September 2020
Purity: >99%
Supplier’s responsibilities: Characterisation of the test item and the documentation of the methods of synthesis, fabrication or derivation and stability.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Acclimatisation period: 36 to 37 weeks prior to the start of the study
- Age at start of treatment: Approx 43 to 50 weeks
- Weight at start of treatment: 2.76 to 4.60 kg
- Housing: Individually in a plastic cage with perforated floors
- Diet: 150g of a standard laboratory rabbit diet per day
- Water: Drinking water provided ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-21
- Humidity (%): Relative humidity of 45-70
- Photoperiod (hrs dark/hrs light): Lighting was controlled by means of a time switch to give 12 hours of artificial light in each 24 hour period.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
The eyes of each animal were examined prior to installation of the test item to ensure that there was no pre-existing corneal damage, iridial inflammation or conjunctival irritation.
The dose was instilled into the right eye by pulling the lower eyelid away from the eye ball to form a cup into which the test item was dropped. The eyelids were then held together for one second before releasing. The left eye remained untreated and unexposed for control purposes. - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- The animals were returned to their cages and checked at least twice during the first hour after dosing and at regular intervals throughout the day to ensure no severe injury passed unnoticed. Ocular reactions to treatment were assessed 1, 24, 48 and 72 hours after treatment.
- Number of animals or in vitro replicates:
- 2 male rabbits
- Details on study design:
- SCORING SYSTEM: The classification system (Kay & Calandra, 1962) was employed on this study.
TOOL USED TO ASSESS SCORE: An ophthalmoscope or pencil beam torch was available for use to facilitate inspection of the eyes.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- fully reversible within:
- Remarks:
- 24 hours
- Remarks on result:
- no indication of irritation
- Remarks:
- The highest total mean score was 10.0 occurring at the one hour observation, however this was fully reversible within 24 hours.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Instillation of the test item gave rise to no initial pain response.
Diffuse crimson-red conjunctival appearance (Grade 2 redness), slight swelling (Grade 1 chemosis) and slight discharge (Grade 2 discharge) were apparent in both animals one hour after installation only. The treated eyes of all animals were overtly normal from 24 hours after installation. - Other effects:
- There was no sign of toxicity or ill health in any rabbit during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The highest total mean score was 10.0 occurring at the one hour observation; accordingly under the criteria 'Kay & Calandra (1962)' the test substance was classified as 'minimally irritating' to the eye. The substance does not require labelling in accordance with European Commission regulation 1272/2008 (CLP).
- Executive summary:
Summary
The purpose of this study was to assess the eye irritation potential of 6 -methyl-3,4 -dihydro-2H-1,4 -benzoxazine (an industrial chemical) to the rabbit. The method followed was that described in:
- Method B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008
- OECD Test Guideline 405, 2020
Two rabbits received a single ocular installation of 0.1 mL of the test substance as supplied; the treated eyes were observed 1, 24, 48 and 72 hours after installation.
Installation of the test item gave rise to no initial pain response.
Diffuse crimson-red conjunctival appearance, slight swelling and slight discharge were apparent in the treated eyes of both animals one hour after installation only. The treated eyes of all animals were overtly normal from 24 hours after installation.
The total mean scores were assigned according to the system of 'Kay & Calandra (1962)'. The highest total mean score was ten occurring at the one hour observation; accordingly under the criteria of 'Kay & Calandra (1962)' the test substance was classified as 'minimally irritating' to the eye.
The substance does not require labelling in accordance with European Commission regulation 1272/2008 (CLP).
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