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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 June, 1979 - 24 June, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- The test was mainly conducted according to the method described by Magnusson and Kligman, "Allergic contact dermatitis in the guinea pig", Ed. Ch.C. Thomas, Springfield, Illinois, USA (1970).
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This available in vivo studies (non LLNA) was sufficient to allow us to filled this endpoint and determined the classification.
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 T 05315
Appearance: Clear colorless liquid
Sample received on 4th, May 1979
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino SPF
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Central Institute for the breeding of laboratory animals TNO, Zeist, The Netherlands
- Age at study initiation: young male animals
- Weight at study initiation: 368 - 562 g
- Housing: Individually housed in suspended stainless steel cages, fitted with wire mesh floors and fronts
- Diet: Stock diet enriched with vitamin C ad libitum
- Water: Tap water ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 1
- Humidity (%): 50 ± 10
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Freund's adjuvant with propylene glycol
- Concentration / amount:
- a concentration of 50% Gyrane was chosen for the induction
- Adequacy of induction:
- other: this concentration induced only moderate irritation reactions in preliminary observations
- Route:
- other: topical application
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% of Gyrane
- Day(s)/duration:
- 48 hours
Challenge
- No.:
- #1
- Route:
- other: topical application
- Vehicle:
- other: vaseline
- Concentration / amount:
- a concentration of 20% which proved to be non-irritating in a preliminary test was used for the challenge
- No. of animals per dose:
- Test animals: 10 males
Control animals: 5 males - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
1) Intradermal injections on day 1:
- Site: shoulder region shaved with electric clippers
Three pairs of intradermal injections in an area of 2x4 cm:
1) 0.05 mL: Freund's Adjuvant
2) 0.05 mL: test substance at a 50% concentration in vehicle (control animals: propylene glycol)
3) 0.05 mL: 1:1 mixture of 50% concentration of the test substance in Freund's Adjuvant (control animals: propylene glycol in Freund's Adjuvant)
2) Topical application on day 8:
- Site: shoulder region shaved with electric clippers
- Amount: 100% test substance
- Area: approximately 8 cm^2
- Exposure period: 48 hours (occlusive)
B. CHALLENGE EXPOSURE
- Day of challenge: day 21, all animals, with the 20% test substance mixed with vaseline
- Exposure period: 24 hours (occlusive)
- Site: right flank, shaven
- Readings: 24 hours after patch removal
OBSERVATIONS
Skin reactions were judged by the method of Draize, as described in J. Pharmacol. 82 (1944) 377-390 - Challenge controls:
- Not applicable.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Preliminary test:
A concentration of 50% was chosen for intradermal induction, because this concentration induced only moderate irritation.
A concentration of 20%, which proved to be non-irritating in the topical induction, was used for the challenge.
Main test:
The intradermal injections given in the induction phase resulted in:
- FCA: abscesses
- 50% test substance in propylene glycol: abscesses;
- 50% test substance in propylene glycol + FCA: abscesses
The 100% concentration test substance induced neither erythema nor edema upon topical application in the induction phase. No sodium lauryl sulphate (SLS) has been used, in order to create a local irritation.
In the challenge, the 20% concentration provoked no erythema or edema in any of the animals in the test group. The control animals showed no reaction.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Gyrane was examined for possible sensitization properties in a maximisation test with guinea pigs. From the reaction to the challenge dose it was concluded that the test material induced no sensitization.
- Executive summary:
In a guinea pig maximisation test method the potential of Gyrane for skin sensitisation was tested similar to OECD 406 guideline.
The intradermal injections (50% test substance concentration) given in the induction phase resulted in abscesses.
The 100% concentration test substance induced neither erythema nor edema upon topical application in the induction phase. Sodium lauryl sulphate (SLS) should have been used, in order to create a local irritation.
In the challenge, the 20% concentration provoked no erythema or edema in any of the animals in the test group. A higher concentration should have been used for challenge (see induction). The control animals showed no reaction. Therefore, the test material does not meet the critera to be classified for skin sensitisation according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances according to this test.
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