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Diss Factsheets
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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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: see 'Remark'
- Remarks:
- Non-GLP study conducted similarly to OECD Guideline 404 with deviations: no data about purity and no certificate of analysis of the test substance; no details on environmental conditions; occlusive patches applied for 24 h and scored at 24 and 72 h after application; observations not followed until the reversibility of the effects
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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no GLP statement; no data about purity; no certificate of analysis of test substance; no details on environmental conditions; occlusive patches applied for 24 h and scored at 24 and 72 h after application; observations not followed until the reversibility
- 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-methyl dihydropyran 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Age at study initiation: Adult
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact or abraded skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 12 rabbits (6 with intact skin and 6 with abraded skin)
- Details on study design:
- - Area of exposure: Back of the animals
- % coverage: Test substance (0.5 mL) was applied under a surgical patch (1 inch x 1 inch) to the intact or abraded skin site on each animal.
- Type of wrap used: The patches were fixed to the application site by means of adhesive tape and the entire trunk of the rabbits was wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances.
REMOVAL OF TEST SUBSTANCE
- After an exposure period of 24 h, the patches and the applied material were removed.
SCORING SYSTEM:
- Skin reactions were scored at 24 and 72 h after application according to Draize scoring system (1944).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24 and 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Irritant / corrosive response data:
- - After 24 h, very slight or well-defined erythema was generally noted in animals.
- After 72 h, very slight erythema, slight to distinct scaliness and very slight oedema were noted in 4/12 rabbits.
- After 24 and 72 h, focal haemorrhages were noted on the abraded skin of one rabbit. It was stated by the author that this rabbit had an abnormally sensitive skin.
- No distinct differences were noted between the reactions on the intact skin and abraded skin. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.1/1: Skin irritation data for individual rabbits
Rabbit number |
Irritation scores (Intact skin) |
|||||
24 h |
72 h |
Mean (24 and 72 h) |
||||
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
|
1 |
2 |
1 |
1 |
1 |
1.5 |
1.0 |
2 |
1 |
0 |
2 |
0 |
1.5 |
0.0 |
3 |
2 |
0 |
1 |
1 |
1.5 |
0.5 |
4 |
1 |
0 |
1 |
0 |
1.0 |
0.0 |
5 |
1 |
0 |
1 |
0 |
1.0 |
0.0 |
6 |
1 |
0 |
1 |
0 |
1.0 |
0.0 |
Mean (all 6 animals) |
1.3 |
0.3 |
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 skin according to the Directive 67/548/EEC and the CLP Regulation.
- Executive summary:
In a primary dermal irritation study performed similarly to OECD Guideline 404, 12 New Zealand White rabbits were dermally exposed to 0.5 mL of Reaction mass of 3,6-dihydro-4-methyl-2-phenyl-2H-pyran and tetrahydro-4-methylene-2-phenyl-2H-pyran, under an occlusive patch (1 inch X 1 inch) to intact or abraded skin of the dorsal region. After an exposure period of 24 h, the patches and the applied material were removed and skin reactions were scored by Draize method. A second reading was recorded 48 h later (72 h after application). Irritation scores at 48 h after application were derived using the worst case scores recorded at 24 or 72 h.
After 24 h, very slight or well-defined erythema was generally noted in animals. After 72 h, very slight erythema, slight to distinct scaliness and very slight oedema were noted in 4/12 rabbits. After 24 and 72 h, focal haemorrhages were noted on the abraded skin of one rabbit. It was stated by the author that this rabbit had an abnormally sensitive skin. No distinct differences were noted between the reactions on the intact skin and abraded skin.
The calculated mean scores for each individual lesion for all animals within scoring times (24 and 72 h) were as follows: 1.3 for erythema score (intact skin) and 0.3 for oedema score (intact skin).
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 skin according to the Directive 67/548/EEC and the CLP Regulation.
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