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Diss Factsheets
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EC number: 944-251-2 | 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 / corrosion, other
- Remarks:
- Available In vivo studies were sufficient to allow us to filled this endpoint and determined the classification.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 17, 1985 - December 30, 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The study has been performed equivalent to OECD 404 guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: EEC Directive 79-831, Annex V, Part B: Methods for the determination of toxicity, B.4. Acute toxicity, skin irritation, dated December 1983.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-butyl-3,6-dihydro-4,6-dimethyl-2H-pyran
- EC Number:
- 246-099-6
- EC Name:
- 2-butyl-3,6-dihydro-4,6-dimethyl-2H-pyran
- Cas Number:
- 24237-01-2
- Molecular formula:
- C11H20O
- IUPAC Name:
- 2-butyl-4,6-dimethyl-3,6-dihydro-2H-pyran
- Reference substance name:
- 6-butyl-3,6-dihydro-2,4-dimethyl-2H-pyran
- EC Number:
- 246-098-0
- EC Name:
- 6-butyl-3,6-dihydro-2,4-dimethyl-2H-pyran
- Cas Number:
- 24237-00-1
- Molecular formula:
- C11H20O
- IUPAC Name:
- 6-butyl-2,4-dimethyl-3,6-dihydro-2H-pyran
- Reference substance name:
- 2-butyltetrahydro-6-methyl-4-methylene-2H-pyran
- EC Number:
- 246-101-5
- EC Name:
- 2-butyltetrahydro-6-methyl-4-methylene-2H-pyran
- Cas Number:
- 24237-02-3
- Molecular formula:
- C11H20O
- IUPAC Name:
- 2-butyl-6-methyl-4-methylenetetrahydro-2H-pyran
Constituent 1
Constituent 2
Constituent 3
- Specific details on test material used for the study:
- Material Identification (as stated in the report) : Gyrane ST 2
Appearance: Clear yellow slightly viscous liquid
Sample received on: November 25, 1985
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ENKI-Konijnenfarm, Someren, The Netherlands
- Weight at study initiation: 2500 - 3500 g
- Housing: Individually in suspended, galvanized cages, fitted with wire-mesh floor and front.
- Diet and water: provided ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 40 - 70
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- The skin reactions were assessed directly, 24, 48 and 72 hours and 7 and 13 days after the removal of the dressings and test substance.
- Number of animals:
- 6 male adults
- Details on study design:
- STUDY DESIGN
The test substance is brought on the intact and abraded skin under a surgical patch measuring 1 inch x 1 inch. The patch were fixed to the application site by means of adhesive tape and the entire trunk of each rabbit was wrapped with an impervious material to maintain the test patches in position and to retard the evaporation of the test material.
TEST SITE
Twenty four hours prior to applying the material, the hair is removed from the back and flanks of the animals with an electric clipper in such a way as to avoid abrasions.
Six rabbits are treated on the intact skin and on the abraded skin. The abrasions are minor incisions of the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding.
REMOVAL OF TEST SUBSTANCE
Four hours after the application, the dressing and test substance was removed.
SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 3452 and 3455
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 3453 and 3454
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 3456 and 3457
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- edema score
- Basis:
- animal: 3452, 3453, 3454, 3456 and 3457
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- edema score
- Basis:
- animal: 3455
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- After 4 to 76 hours after exposure, the dermal effects observed in all six animals consisted of very slight or well-defined erythema with or without very slight oedema. After seven days, very slight erythema with or without very slight oedema was observed in five out of six animals. There were no significant differences between the effects of the intact skin and the effects of the abraded skin. After 13 days, all skin effects had cleared completely.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- In an skin irritation study with rabbits, performed equivalent to OECD 404 test guidelines and GLP principles, slight irritation was observed but no sufficient to classify according the CLP Regulation (EC) No. 1272/2008.
- Executive summary:
Gyrane St 2 was tested in a skin irritation study with rabbits, performed equivalent to OECD 404 test guideline and GLP principles.
After 4 to 76 hours after exposure, the dermal effects observed in all six animals consisted of very slight or well-defined erythema with or without very slight oedema. After seven days, very slight erythema with or without very slight oedema was observed in five out of six animals. There were no significant differences between the effects of the intact skin and the effects of the abraded skin. After 13 days, all skin effects had cleared completely.
Based on the results, slight irritation was observed but no sufficient to classify according the CLP Regulation (EC) No. 1272/2008.
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