Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 272-447-1 | CAS number: 68845-00-1
- 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
- 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:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Buehler, E.V., Arch. Dermatol. 91, 171, 1965 (updated by Buehler, E.V. and Ritz, H.L., Current Concepts in Cutaneous Toxicity, pp 215-40, 1980.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- LLNA not available at the time of testing.
Test material
- Reference substance name:
- rel-(1R,2R,5S)-2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane
- Cas Number:
- 125673-86-1
- Molecular formula:
- C15H26O
- IUPAC Name:
- rel-(1R,2R,5S)-2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane
- Reference substance name:
- rel-(1R,2S,5S)-2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane
- Molecular formula:
- C15H26O
- IUPAC Name:
- rel-(1R,2S,5S)-2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane
- Reference substance name:
- 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)butan-2-one
- EC Number:
- 250-657-4
- EC Name:
- 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)butan-2-one
- Cas Number:
- 31499-72-6
- Molecular formula:
- C13H22O
- IUPAC Name:
- 4-(2,6,6-trimethylcyclohex-2-en-1-yl)butan-2-one
- Test material form:
- liquid
Constituent 1
Constituent 2
impurity 1
- Specific details on test material used for the study:
- Test item: ST 50 C 85 (ST 50 C 85 corresponds to the substance with CAS Nr 68845-00-1 and EC Nr 272-447-1 Boisiris)
Aspect: clear colourless liquid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Female guinea pigs of the Dunkin-Hartley strain were supplied by D.Hall, Darley Oakes, Burton-on-Trent, Staffordshire, England. After arrival at the testing facilities the animals were allowed an acclimatisation period of 17 days.
The animals were housed in groups of five in grid bottomed polypropylene cages and identified, within the cage, by ear marking. A commercially available pelleted diet with additional vitamin C and tap water containing 0.01 % vitamin C were provided ad libitum.
The animal room was air conditioned, set to maintain a temperature within the range 17 - 25 °C. Artificial lighting by fluorescent tubes was set to an artificial cycle of twelve hours light/twelve hours dark.
Study design: in vivo (non-LLNA)
- Details on study design:
- Dose range finding
The primary irritancy of the test material was determined by an initial study in four guinea pigs. The day before dosing the backs and flanks, the animals were clipped free of fur. Four concentrations of the test material (100%, 50%, 25% and 12.5%) were used. The dilutions were prepared using ethanol. Each concentration rotated on each animal (two either side of the mid line) and the relative position of each concentration roated on each animal to minimise any variation in response arising from different skin locations.
The material was applied by soaking a 20 mm square of surgical lint with 0.5 ml of the material and placing this onto the selcted site. The lint was held in position by a length of 'Blenderm' surgical tape which acted as an impermeable barrier. This assembly was secured to the animal using a length of 'Elastoplast' elastic adhesive bandage. The patch assemblies were removed after six hours. 24 and 48 hours after dosing commenced, the treatment sites were examined for erythema and oedema.
Main study
The left shoulder of the ten test animals was clipped free of fur. The following day (Day 1 of the study) a 20 mm square of surgical lint was soaked with 0.5 ml of the undiluted test material and placed onto the prepared skin. The site was covered by a length of 'Blenderm' surgical tape and this was secured by wrapping the animal with a length of 'Elastoplast' elastic adhesive bandage. The dressings remained in place for six hours. This dosing procedure was repeated at weekly intervals on days eight and fifteen.
Main study - Challenge Procedure
On day 28 of the study the right flank of the animals in both test and control groups was clipped free of fur. The following day (Day 29) all animals of both groups were dosed with 0.5 ml of the undiluted test material and 0.5 ml a 50 % concentration of test material. Each concentration was applied to a 20 mm square surgical lint patch. The patches were secured to the right flank in the same manner as described for the induction procedure and remained in position for six hours. 24 and 48 hours after dosing commenced each treatment site was examined and scored.
The following scoring scale was used to describe any observed response:
0 = No reaction
0.5 = Very faint erythema, non confluent
1 = Faint erythemam usually confluent
2 = Moderate erythema
3 = Strong erythema, with or without oedema
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
No visible response was exhibited by any animal of the test or control group when chalenged with the undiluted material and a 50 % concentration of the material in ethanol.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- From the results of this study there was no evidence to suggest that the test material acts as a sensitiser in the guinea pig.
- Executive summary:
Boisiris is not a skin sensitiser.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.