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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 253-568-9 | CAS number: 37609-25-9
- 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:
- 30 August - 13 October 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The in vivo study (non LLNA) was conducted prior to the new approach on use of alternative methods to animal testing described in the Draft version (5) published by ECHA in June 2016 : Chapter R.7a: Endpoint specific guidance.
Indeed as recommended by the ECHA Guidance on Information Requirements and Chemical Safety Assessment publised version 4.1 (Chapter R.7a) published in October 2015, the assessment of skin sensitization is firstly based on the available human, animal and alternative data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- As the In vivo non LLNA study was already available and reliable to assess the skin sensitization potential and determined the skin sensitization classification of VELVIONE, it has been used to fill the sensitization endpoint and no futher test were conducted.
Test material
- Reference substance name:
- (E)-cyclohexadec-5-enone
- Cas Number:
- 35951-24-7
- Molecular formula:
- C16H28O
- IUPAC Name:
- (E)-cyclohexadec-5-enone
- Reference substance name:
- (Z)-cyclohexadec-5-enone
- Cas Number:
- 21944-95-6
- Molecular formula:
- C16H28O
- IUPAC Name:
- (Z)-cyclohexadec-5-enone
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Name (as stated in the report): Velvione
Batch: 9000319175
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino female, GOHI (SPF)
- Sex:
- female
- Details on test animals and environmental conditions:
- Conditions: Air conditioned with 15 -20 air changes per hour, temperature of 22 +/- 2°C, relative humidity of 55 +/- 10%, 12 hours artificial light and 12 hours of darkness
Accomodations: Individually housed in metallic/ steel boxes
Diet: Kliba 3418 ad libitium
Water: Community tap water from Basle ad libitium
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- other: Ethanol
- Concentration / amount:
- Contraction: 30%, 10% and 5% in Ethanol
Amount: 100 microL/8 cm2 - Day(s)/duration:
- 4 consecutive weeks
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: Ethanol
- Concentration / amount:
- Concentrations: 1%, 0.5%, 0.1%, 0.05% and 0%
Amount: 25 microL/2cm2 - Day(s)/duration:
- four week after the beginning of the induction
- Adequacy of challenge:
- other: non-irritating concentrations
- No.:
- #2
- Route:
- epicutaneous, open
- Vehicle:
- other: Ethanol
- Concentration / amount:
- Concentrations: 1%, 0.5%, 0.1% and 0%
Amount: 25 microL/2cm2 - Day(s)/duration:
- Two weeks later the 1st challenge
- Adequacy of challenge:
- other: non-irritating concentrations
- No. of animals per dose:
- 1 dose per animal
- Details on study design:
- Induction:
During the induction phase of sensitization, Velvione was applied epicutaneously onto skin of the test animals 5 days a week for 4 consecutive weeks. Six animal per treatement group were treated on the right flank with the test article at the concentrations of 30%, 10% and 5% in ethanol, respectively. Treatement sites were left open between the subsequent applications. The control group (10 animals) was treated similarly biut with the vehicul only.
Challenge 1:
To assess the sensitization responses, 4 weeks beginning of the induction treatment a challenge application has been carried out. The animals (test and control) have been exposed on the left flank, by open epicutaneous way, to Velvione at the non-irritating concentrations of 1%, 0.5%, 0.1% and 0.05% in ethanol.
Challenge 2:
Two week later a second challenge was done similarly with the test article. The cutaneous reactions, such as erythema and oedema formation were evaluated daily at each individual treatment site during the induction period.
Challenge reactions were assessed at 24 and 48 hours after application. - Challenge controls:
- Challenge 1 and 2: The animals (test and control) have been exposed on the left flank, by open epicutaneous way, to Velvione at the non-irritating concentrations of 1%, 0.5%, 0.1% and 0.05% in ethanol.
- 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:
- other: 3 Test groups (30%, 10% and 5% treated during the induction phase)
- Dose level:
- 1%, 0.5%, 0.1%, 0.05% and 0.0%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- other: 1st reading: 24 hours after the 1st and 2nd challenge
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: 3 test groups (30%, 10% and 5% treated during the induction phase)
- Dose level:
- 1%, 0.5%, 0.1%, 0.05% and 0.0%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- other: 2nd reading: 48 hours after the 1st and 2nd challenge
Any other information on results incl. tables
Velvione did not induce any skin reactions as such in the test or control animals during the challenge phase of the experiment. The test articple when applied at the concentrations of 30%, 10% and 5% in ethanol induced slight to intense cutaneous responses of primary irritant nature during the induction phase of the study only.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the above experimental data, it is concluded that the topically applied Velvione when used under the conditions of this study (<= 30%) did not induce cutaneous sensitization in the guinea pigs.
Hence, VELVIONE does not met the criteria for skin sensitization classication according the CLP Regulation (EC) No. 1272/2008. - Executive summary:
VELVIONE was tested under the test conditions decribed below for evaluation of the skin sensitzation potential according to the OECD guideline 406.
During the induction phase of sensitization, Velvione was applied epicutaneously onto skin of the test animals 5 days a week for 4 consecutive weeks. Six animal per treatement group were treated on the right flank with the test article at the concentrations of 30%, 10% and 5% in ethanol, respectively. Treatement sites were left open between the subsequent applications. The control group (10 animals) was treated similarly biut with the vehicul only.
To assess the sensitization responses, 4 weeks beginning of the induction treatment a challenge application has been carried out. The animals (test and control) have been exposed on the left flank, by open epicutaneous way, to Velvione at the non-irritating concentrations of 1%, 0.5%, 0.1% and 0.05% in ethanol.
Two week later a second challenge was done similarly with the test article. The cutaneous reactions, such as erythema and oedema formation were evaluated daily at each individual treatment site during the induction period. Challenge reactions were assessed at 24 and 48 hours after application.
Velvione did not induce any skin reactions as such in the test or control animals during the challenge phase of the experiment. The test articple when applied at the concentrations of 30%, 10% and 5% in ethanol induced slight to intense cutaneous responses of primary irritant nature during the induction phase of the study only.
It is concluded that the topically applied Velvione when used under the conditions of this study (<= 30%) did not induce cutaneous sensitization in the guinea pigs.
Hence, VELVIONE does not met the criteria for skin sensitization classication according the CLP Regulation (EC) No. 1272/2008.
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.