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Diss Factsheets
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EC number: 943-533-2 | 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
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Reaction mass of 6-ethyl-3-methyloct-5-en-1-ol and 6-ethyl-3-methyloct-6-en-1-ol
- Molecular formula:
- C11H22O
- IUPAC Name:
- Reaction mass of 6-ethyl-3-methyloct-5-en-1-ol and 6-ethyl-3-methyloct-6-en-1-ol
- Test material form:
- other: liquid
- Details on test material:
- Identity: Super Muguet
Description: Colourless to pale yellow liquid
Batch Number: 9000408259
Purity: 99.9%
Stability: Stable under storage conditions
Expirt Date: 08 Dec 2002
Stability of test item formulation: Unkown and therefore excluded from Statement of Compliance
Storage Conditions: In the original container at room temperature (17 - 20 °C), away from direct sunlight.
Safety Precautions: Routine hygenic procedures (gloves, goggles, face mask)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Test system: Mice, CBA/Jlbm(SPF)
Rationale: Recognised as the recommended test system
Source: RCC Ltd., Biotechnology & Animal Breeding Division, Wolferstrasse 4, CH-4414, Fullinsdorf, Switzerland
Number of animals per group: 4
Number of control group: 1
Age: 7 - 12 weeks (beginning of acclimatization)
Body weight: 16.2 - 22.2 g (beginning of acclimatization period)
Identification: By unique cage number and individual colour code
Randomization: Randomly selected by computed algorithm at time of delivery
Acclimatization: Under test conditions after health examination. Only animals without any signs of illness were used for the study.
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol 70 %
- Concentration:
- 0.5 %, 5 %, 50 % and 100 % (undiluted) in ethanol 70%
- No. of animals per dose:
- 4
- Details on study design:
- In order to study a possible allergenic potential of SUper Mugiet four groups of four female mice each were tested withthe test item at concentrations of 0.5 %, 5 %, 50 % and 100 % (undiluted) in ethanol 70 % by topical application to the dorsum of each ear lobe (left and right) on three consecutive days. A control group of four mice was treated with the vehicle (ethanol 70 %) only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes which were washed subsequently and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a β-scintillation counter.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Alpha-hexycinnamaldehyde was regarded as a sensitizer when tested at concentrations of 10 % and 25 %. At a concentration of 5 % the test item was found to be a non-sensitizer.
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: Group 2 (0.5 %) S.I = 1.3 Group 3 (5 %) S.I = 1.6 Group 4 (50 %) S.I = 6.0 Group 5 (100 %) S.I = 8.7
Any other information on results incl. tables
No deaths occurred during the study.
No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study.
The body weight of the animals, recorded at the start of acclimatization period and prior to necropsy, was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Moderate Criteria used for interpretation of results: EU
- Conclusions:
- The test item Super Muguet was found to be a non-sensitizer when tested as 0.5 % and 5 % dilutions.
Super Muguet showed allergenic potency when tested at concentrations of 50 % and 100 % (undiluted). - Executive summary:
In an in vivo LLNA test, conducted to GLP and according to the OECD Guideline 406 and 429, Super Muguet was found to be a non-sensitizer when tested as 0.5 % and 5 % dilutions. However, Super Muguet showed allergenic potency when tested at concentrations of 50 % and 100 % (undiluted). The EC3 is 19.32.
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.
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