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EC number: 262-475-2 | CAS number: 60857-05-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
Test material
- Reference substance name:
- Tetrahydro-4-methylene-2-(2-methyl-1-propenyl)-2H-pyran
- EC Number:
- 262-475-2
- EC Name:
- Tetrahydro-4-methylene-2-(2-methyl-1-propenyl)-2H-pyran
- Cas Number:
- 60857-05-8
- Molecular formula:
- C10H16O
- IUPAC Name:
- 4-methylidene-2-(2-methylprop-1-en-1-yl)oxane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Age of the animals at day 0: 6 - 7 months
Acclimatization for at least 5 days before application.
Animal identification: via ear tattoo
Body weight(s) on day 0: 3.73 - 3.88 kg
The animals were housed in fully air-conditioned rooms with a room temperature of 20 - 24°C and a relative humidity between 30 - 70%. The day/night rhythm was 12 h dark and 12 h light.
The animals were housed singly in stainless steel wire mesh cages with grating (floor area: 3000 cm2).
The rabbits were offered a standardized animal laboratory diet (ca. 130 g/animal/day) as well as tap water ad libitum.
- Source: Centre Lago S. A., France
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipping of the fur
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin site of same animal
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 d
- Number of animals:
- 3
- Details on study design:
- Before study start, the application area was investigated for signs of pre-existing skin irritaiton of dense patches of hair. Only animals with intact healthy skin were used.
At least 24 h before application clipping of the fur of the dorsolateral part of the trunk of the animals.
Body weights were determined just before application and after the last reading.
The test article was applied in a single dose to the intact untreated skin. The test substance was removed at the end of the exposure period with Lutrol and Lutrol / water (1:1).
The test patches (2.5 x 2.5 cm) were moistened with 0.5 ml of the undiluted test substance.
Application site: flank
Readings: Immediately after removal of the patches, aprox. 1, 24, 48 and 72 h after removal of the patches and then in weekly intervals maximally up to day 14. A check for dead or moribund animal was made twice each working day and once daily at weekends and on public holidays.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritant / corrosive response data:
- Slight to severe erythema and slight to moderate edema, both partly extended beyond the area of exposure, were observed in all animals during the course of the study. Additional findings like scaling, severe scaling partly extended beyond the area of exposure and petechiae were noted in all animals during the observation period.
The cutaneous reactions were not reversible in all animals within 14 days after removal of the patch. Slight erythema and scaling or severe scaling were still present in all animals at study termination (day 14).
Any other information on results incl. tables
The present data fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and a classification "irritating to skin" (R38) and "skin irritant" (category 2) is warranted (based on mean erythema scores >=2.3).
Applicant's summary and conclusion
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