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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 September - 13 December 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
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
Expiration date: August 11, 2001
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Sex: 1 male and 2 females
Age at the start of the treatment: 14 weeks (Males) and 15 weeks (Females)
Identification: By unique cage number and corresponding ear number
Acclimatization: Under laboratory conditions after health examination. Only anmials without any visual sign of illness were used for the study.
Allocation: Male No. 91 and Females 92 - 93
Accomodation: Individually in stainless stell cages equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- As a liquid, 0.5 ml (per animal) was measured with a seringe and applied undiluted as it was supplied by the Sponsor.
- Duration of treatment / exposure:
- The duration of the treatement was 4 hours.
- Observation period:
- Daily from the delivery of animals to the termination of the test.
- Number of animals:
- 1 male and 2 females
- Details on study design:
- Four days before treatment the left flank was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm). The skin of animals was examined approximately 24 hours before treatment, and regrown was again clipped.
On day of the treatment, 0.5 ml of VELVIONE were put on a surgical gauze patch (ca 2.5 cm x 2.5 cm). This gauze patch was applied to approximately 6 cm2 of the intact skin of the clipped area. The patch was covered with a semi occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape. The duration of the treatement was 4 hours. The the dressing was removed and the skin was flushed with lukewarn tap water to clean application site so that any reactions (erythema) were clearly visible at that time.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 91
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: NA
- Irritation parameter:
- erythema score
- Basis:
- animal: 92 and 93
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal: 91, 92 and 93
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: NA
- Irritant / corrosive response data:
- The dermal exposure to VELVIONE caused a very slight erythema at the 1-hour reading in both females which persisted until 72 hour examinations. All skin reactions desappeared 7 days after treatment.
No irriversible alteration of the treated skin were observed nor were corrosive effects evident. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the test and observation period. No mortality occured.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- VELVIONE is therefore considered to be "non-irritating" to rabbit skin. Hence, VELVIONE does not met the criteria for skin irritation 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 irritation potential according to the OECD guideline 404.
Four days before treatment the left flank was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm). The skin of animals was examined approximately 24 hours before treatment, and regrown was again clipped.
On day of the treatment, 0.5 ml of VELVIONE were put on a surgical gauze patch (ca 2.5 cm x 2.5 cm). This gauze patch was applied to approximately 6 cm2 of the intact skin of the clipped area. The patch was covered with a semi occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape. The duration of the treatement was 4 hours. The the dressing was removed and the skin was flushed with lukewarn tap water to clean application site so that any reactions (erythema) were clearly visible at that time.
Under the conditions of this test, VELVIONE is considered to be "non-irritating" to rabbit skin. Hence, VELVIONE does not met the criteria for skin irritation classication according the CLP Regulation (EC) No. 1272/2008.
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