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EC number: 943-338-2 | CAS number: -
- 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:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP study conducted similarly to OECD Guideline 405 with deviations: no data about purity and no certificate of analysis of the test substance; no details on environmental conditions; age of animals at the start of study was not reported
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no GLP statement; no data about purity and no certificate of analysis of the test substance; no details on environmental conditions; age of animals at the start of study was not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of 4-methylene-2-phenyltetrahydro-2H-pyran and 4-methyl-2-phenyl-3,6-dihydro-2H-pyran
- EC Number:
- 943-338-2
- Molecular formula:
- C12H14O
- IUPAC Name:
- Reaction mass of 4-methylene-2-phenyltetrahydro-2H-pyran and 4-methyl-2-phenyl-3,6-dihydro-2H-pyran
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 2-Phenyl-4-methyldihydropyran
- Physical state: Clear colourless liquid with a pungent odour
- Date received: 08 October 1980
Please note that although the substance is stated as a mono-constituent substance 2-Phenyl-4-methyldihydropyran in the report, recent analytical data has determined the substance to be a multi-constituent (Reaction mass of 3,6-dihydro-4-methyl-2-phenyl-2H-pyran and tetrahydro-4-methylene-2-phenyl-2H-pyran). As the chemical manufacturing process has not changed since the report was written, the recent analytical information is relevant to the batch which was tested.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Housing: Animals were housed individually in cages.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- Six
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Eyes were not washed following instillation and the animals were released immediately.
SCORING SYSTEM: Ocular lesions were observed at 24, 48 and 72 h and 7 days after instillation and graded according to a scale comparable to OECD guideline 405.
TOOL USED TO ASSESS SCORE: Ocular reactions were read using a binocular magnifying glass. The diagnosis of corneal damage was confirmed, if necessary, by staining the eyes of the animals with fluorescein-impregnated papers. After flushing the excess fluorescein solution, the eyes were examined in a dark room under UV illumination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: average of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: average of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: average of 24, 48 and 72 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: average of 24, 48 and 72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritant / corrosive response data:
- - Slight redness and slight swelling of the conjunctivae were noted in 5/6 and 2/6 rabbits, respectively.
- Within 7 days, these lesions had cleared up completely. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.2/1: Scores for ocular lesions
Animal no. |
Cornea |
Iris |
Conjunctivae redness |
Conjunctivae chemosis |
||||||||||||
24 h |
48 h |
72 h |
Mean* |
24 h |
48 h |
72 h |
Mean* |
24 h |
48 h |
72 h |
Mean* |
24 h |
48 h |
72 h |
Mean* |
|
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0.67 |
1 |
0 |
0 |
0.33 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0.33 |
0 |
0 |
0 |
0.00 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0.67 |
0 |
0 |
0 |
0.00 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1.00 |
1 |
0 |
0 |
0.33 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0.33 |
0 |
0 |
0 |
0.00 |
6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0.00 |
Mean# |
0 |
0 |
0.50 |
0.11 |
*mean of scores at 24, 48 and 72 h
#mean of scores of all 6 animals
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, Reaction mass of 3,6-dihydro-4-methyl-2-phenyl-2H-pyran and tetrahydro-4-methylene-2-phenyl-2H-pyran is not classified as irritating to eyes according to the Directive 67/548/EEC and the CLP Regulation.
- Executive summary:
In an eye irritation study conducted similarly to the OECD Guideline 405, six rabbits of the New Zealand White strain were exposed to 0.1 mL of Reaction mass of 3,6-dihydro-4-methyl-2-phenyl-2H-pyran and tetrahydro-4-methylene-2-phenyl-2H-pyran in their one eye, while the other eye remained untreated and served as control. The eyelids were then gently held together for 1 second to avoid any loss of the test material. Eyes were not washed and ocular reactions were read at 24, 48 and 72 h and 7 days following instillation using a binocular magnifying glass. The diagnosis of corneal damage was confirmed, if necessary, by staining the eyes of the animals with fluorescein-impregnated papers. After flushing the excess fluorescein solution, the eyes were examined in a dark room under UV illumination. Ocular reactions were graded according to a scale comparable to the OECD Guideline 405.
Slight redness and slight swelling of the conjunctivae were noted in 5/6 and 2/6 rabbits, respectively. Within 7 days, these lesions had cleared up completely. The calculated mean scores for each individual lesion for all animals within three scoring times (24, 48 and 72 h) were as follows: 0.00 for cornea score; 0.00 for iris score; 0.50 for conjunctivae score and 0.11 for chemosis score. In this study, 2-phenyl-4-methyldihydropyran is not considered as irritating to eyes in rabbits.
Under the test conditions, Reaction mass of 3,6-dihydro-4-methyl-2-phenyl-2H-pyran and tetrahydro-4-methylene-2-phenyl-2H-pyran is not classified as irritating to eyes according to the Directive 67/548/EEC and the CLP Regulation.
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