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Diss Factsheets
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EC number: 259-160-7 | CAS number: 54423-67-5
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an U.S.E.P.A. O.T.S. Testing Guideline with GLP compliance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Pre existing study
Test material
- Details on test material:
- As per IUCLID5 Sections 1.1. - 1.4.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Young Adult Male Hartley guinea pigs were acquired from Sasco, Inc., Omaha, Nebraska and weighted 300 - 500 grams at time of dosing. The animals were individually housed in stainless steel, wire mesh bottom cages. The animal room was individually ventilated at no less than 10 air changes per hour. The temperaturewas maintained at 64 - 79°F and relative humidity was 40 - 70%. Room light was a 12/12 hour light/dark cycle. Fresh Agway Certified Guinea Pig Feed was provided ad libitum. Water was provided ad libitum via an automatic watering system.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 0.5 ml of neat vinyl neononanoate for the induction phase and 0.5 ml of a 1/10 dilution in corn oil for the challange phase.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 0.5 ml of neat vinyl neononanoate for the induction phase and 0.5 ml of a 1/10 dilution in corn oil for the challange phase.
- No. of animals per dose:
- 44 total
- Details on study design:
- Before exposure to test article, positive control or vehicle article, a strip of hair along one side of the dorsal midline was removed by clipping and shaving. Animals were clipped and shaved throughout the study as needed. For exposures test articles were applied to gauze pads and placed on the shaved area. The gauze pads were stabilized with a strip of hypoallergenic tape. An occlusive barrier consisting of a rubber patch was applied to the test site and secured with 2 inch Blenderm around the back and abdomen. After six hours, all wrappings were removed. Approximately 24 and 48-hours post treatment, the skin was scored using the Draize scoring method.
For each induction phase, 0.5 ml of neat vinyl neononanoate or 0.5 ml of 0.3% DNCB positive control was applied to one site as described previously. Each subsequent application of test or positive control article was applied on the same site. The animals were exposed for six hours once a week, for a period of three weeks.
Thirteen days after the last induction dose was applied, the guinea pigs from the negative challenge control, positive control and test groups were clipped on a naive site as previously described. This site was located on the opposite side of the dorsal midline from the induction test site. The following day (Day 14 post induction applications), 0.5 ml of a 1:10 v/v dilution of vinyl neononanoate prepared in corn oil was applied to a naive site on each guinea pig in the test article group and the corresponding challenge control group. A volume of 0.5 ml of corn oil was applied as described previously on each guinea pig in the vehicle challenge control group. A volume of 0.5 ml of the positive control article (0.2% DNCB prepared in 80% ethanol) was applied in a similar manner to each guinea pig in the positive control group and the corresponding challenge control group.
- Challenge controls:
- Yes
- Positive control substance(s):
- yes
- Remarks:
- 0.2% DNCB prepared in 80% ethanol)
Results and discussion
- Positive control results:
- For the positive control DNCB, Challenge response grades ranged from 4 - 5 with a Severity Index of 4.5 & 4.2 at 24 and 48 hr observation times respectively in all the animals.
In vivo (non-LLNA)
Results
- Reading:
- other: Both 24 and 48 hr scorings.
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 ml neat.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: other: Both 24 and 48 hr scorings.. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 ml neat.. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The results of the challenge indicate that under the conditions of this test, the positive control DNCB is a delayed contact sensitizer and vinyl neononanoate is not a delayed contact sensitizer.
- Executive summary:
When tested for skin sensitization potential by an U.S.E.P.A. O.T.S. 798.4100 Skin Sensitization Testing Guideling applying the Buehler guinea pig methodology, vinyl neononanoate was found not to be a dermal sensitizer under the conditions of this GLP study.
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.
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