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EC number: 405-040-6 | CAS number: 63500-71-0 CIS/TRANS-TIMO; FLOROL; FLOROSA
- 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:
- From 30 October to 21 November 1991
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performed before LLNA was formally validated and available as OECD guideline.
Test material
- Reference substance name:
- A mixture of: cis-tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4-methylpyran-4-ol
- EC Number:
- 405-040-6
- EC Name:
- A mixture of: cis-tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4-methylpyran-4-ol
- Cas Number:
- 63500-71-0
- Molecular formula:
- C10 H20 O2
- IUPAC Name:
- 4-methyl-2-(2-methylpropyl)oxan-4-ol
- Details on test material:
- - Lot/batch No.: S1943401
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 70% acetone; 30% polyethylene glycol 400
- Concentration / amount:
- 25 % test substance in vehicle for challenge
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 70% acetone; 30% polyethylene glycol 400
- Concentration / amount:
- 25 % test substance in vehicle for challenge
- No. of animals per dose:
- 10 male/ 10 female
- Details on study design:
- RANGE FINDING TESTS:
Several concentrations of the test substance (in 0.01 % dodecylbenzene sulphonate/ 0.9 % physiological saline to 100 %) were injected intradermally to determine a suitable concentration of test substance for induction of sensitisation. Preliminary occluded patch irritation tests were carried out using several concentrations of the test substance (in 70 % acetone/ 30 % polyethylene glycol 400) to determine suitable concentrations of test substance for both induction of sensitisation and for sensitisation challenge. Intradermal injection of 1.0 % test item was the highest concentration inducing mild to moderate signs of skin irritation. The topical application of 99 % test item caused mild erythema. 25 % was the highest non-irritating test item concentration for topical treatment.
MAIN STUDY
A. INDUCTION EXPOSURE
Induction consisted of two stages, intradermal injection followed seven days later by occluded patch application.
Intradermal injection:
The hair was clipped from a 2cm x 4cm area of skin in the dorsal shoulder area and three pairs of intradermal injections made with clipped area as follows:
1. Two 0.1 ml injections of 50 % Freund´s Complete Adjuvant (FCA) in 0.01 % dodecylbenzene sulphonate/ 0.9% physiological saline to 100%.
2. Two 0.1 ml injections of 1.0 % active ingredient Florosa in 0.01 % dodecylbenzene sulphonate/ 0.9 % physiological saline to 100 %.
3. Two 0.1 ml injections of test substance in 0.01 % dodecylbenzene sulphonate/ 0.9 % physiological saline to 100 % mixed 50: 50 with FCA such that the final concentration of test material injected was the same as that in 2. above.
Occluded patch application:
Seven days later the same 2cm x 4cm area was clipped and shaved. A 2cm x 4cm filter paper patch, attached by double-sided adhesive tape to a 4cm x 6cm piece of thin polyethene, was saturated with 99 % active ingredient Florosa placed over the shaved site. The patch was held in place for 48 hours by adhesive plaster wrapped around the trunk behind the forelimbs.
B. CHALLENGE EXPOSURE
Twelve days after the application of the induction patch the guinea pigs were challenged on the clipped and shaved flank by an occluded patch. For each animal, an 8 mm diameter filter paper patch in an 11 mm aluminium patch test cup was saturated with 25 % active ingredient Florosa in 70 % acetone/ 30 % polyethylene glycol 400 and the patch applied to the shaved flank. The patch was held in place for 24 hours by adhesive plaster wound around the trunk. The treatment sites were examined for evidence of sensitisation 24 and 48 hours after removal of the patches using the scoring system. - Challenge controls:
- At the same time as the test animals were selected, ten other guinea pigs were selected as treated controls. The control guinea pigs were selected so that their body weights were similar to those of the test guinea pigs at that challenge. The guinea pigs received four intradermal injections of 50 % Freund´s Complete Adjuvant in 0.01 % dodecylbenzene sulphonate/ 0.9% physiological saline to 100 %, followed seven days later by a 24 hour occluded patch of test solvent over the injection sites. At the challenge the control guinea pigs were challenged with test material in exactly the same way as the test animals.
- Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic aldehyde and hydroxycitronellal
Results and discussion
- Positive control results:
- The results obtained with the positive control substances demonstrated the sensitivity and reliability of the experimental technique used.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % test substance in vehicle for challenge
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % test substance in vehicle for challenge. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % test substance in vehicle for challenge
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % test substance in vehicle for challenge. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- No evidence of sensitization reactions in any test animals
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