Registration Dossier
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: 815-500-1 | CAS number: 1853175-99-1
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22/07/2015-24/07/2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
Test material
- Reference substance name:
- 1,3-dioxane, 2-(3,3-dimethyl-1-cyclohexen-1-yl)-2,5,5-trimethyl
- Cas Number:
- 1853175-99-1
- Molecular formula:
- C15H26O2
- IUPAC Name:
- 1,3-dioxane, 2-(3,3-dimethyl-1-cyclohexen-1-yl)-2,5,5-trimethyl
Constituent 1
- Specific details on test material used for the study:
- Sponsor identification: MADERAL ZA1076
Identification of the item tested: PH-15/0488
Date of reception: 08/07/2015
Container: Glass flash x1
Quantity: 118.10g (container + content)
Batch n°: 100026324
Production date: 11/03/2015
Form: liquid
Colour: colourless
Storage: room temperature / darkness
Expiry date: 10/03/2016
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- Suppliers : Elevage Janvier Labs
Animals nullipare, non-pregnant
Randomly allocated to cages
Acclimatation: 5 days
Age at the start of the study: 8 weeks
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 100%, 50%, 25%
- No. of animals per dose:
- 4
- Details on study design:
- Preliminary screening test (with 100% concentration / one mice):
- No mortality and no signs of systemic toxicity were noted
- Slight dryness was noted on day 6 at the concentration of 100%
- No other cutaneous reactions were noted at the concentration of 100%
- Therefore this concentration was chosen as the highest concentration for the main study - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Positive substance classified in category 1 "skin sensitisation", the control is validate.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- ca. 1.55
- Variability:
- 0.21
- Test group / Remarks:
- Concentration: 25%
- Key result
- Parameter:
- SI
- Value:
- ca. 1.79
- Variability:
- 0.26
- Test group / Remarks:
- Concentration: 25%
- Key result
- Parameter:
- SI
- Value:
- ca. 0.77
- Variability:
- 0.18
- Test group / Remarks:
- Concentration: 25%
- Key result
- Parameter:
- SI
- Value:
- ca. 1.2
- Variability:
- 0.20
- Test group / Remarks:
- Concentration: 25%
- Key result
- Parameter:
- SI
- Value:
- ca. 2.05
- Variability:
- 0.30
- Test group / Remarks:
- Concentration: 50%
- Key result
- Parameter:
- SI
- Value:
- ca. 1.47
- Variability:
- 0.44
- Test group / Remarks:
- Concentration: 50%
- Key result
- Parameter:
- SI
- Value:
- ca. 1.11
- Variability:
- 0.13
- Test group / Remarks:
- Concentration: 50%
- Key result
- Parameter:
- SI
- Value:
- ca. 1.21
- Variability:
- 0.17
- Test group / Remarks:
- Concentration: 50%
- Key result
- Parameter:
- SI
- Value:
- ca. 2.38
- Variability:
- 0.26
- Test group / Remarks:
- Concentration: 100%
- Key result
- Parameter:
- SI
- Value:
- ca. 1.43
- Variability:
- 0.14
- Test group / Remarks:
- Concentration: 100%
- Key result
- Parameter:
- SI
- Value:
- ca. 1.58
- Variability:
- 0.95
- Test group / Remarks:
- Concentration: 100%
- Key result
- Parameter:
- SI
- Value:
- ca. 1.03
- Variability:
- 0.11
- Test group / Remarks:
- Concentration: 100%
- Cellular proliferation data / Observations:
- A stimulation of more than 1.6 was recorded with the highest tested concentrations.
The SI calculated by individual approach was 1.33, 1.46 and 1.61 for the treated groups at 25%, 50% and 100%, respectively.
EC1.6 was determined : 96.67%
Study positive: SI higher than 1.6 in the greatest group at 100% (SI = 1,61) and a dose-response relationship is noted. However, in accordance with the test guideline, it may be considered as a borderline result.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Executive summary:
The skin sentitzation was performed according to the OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA). The result of the study was positive due to the fact that the SI is higher than 1.6 in the treated group at 100% and a dose-response relationship is noted. However, in accordance with the test guideline, it may be considered as a borderline result (i.e. SI value between 1.6 and 1.9). No cutaneous reaction were noted.
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.

Route: .live2