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Diss Factsheets
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EC number: 483-350-0 | 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: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 - 17 Mar 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The study followed the standard guideline of reference (OECD 429), which describes a procedure designed to evaluate this endpoint, but with an important protocol deviation. Cellular proliferation was not determined by incorporated radioactivity, thus no disintegrations per minute (DPM). Instead, lymph node cell count was used as direct measurement of cell proliferation and a lower cut-off value of 1.4 times increase of stimulation index was used. The results were reviewed for reliability and assessed as valid, and the study was conducted under GLP condition.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted in 2002
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted in 2010
- Deviations:
- yes
- Remarks:
- Proliferation was assessed on Day 4 instead of Day 6, determined by lymph node cell count instead of incorporated radioactivity and the analysis was not part of the GLP study, no Draize scoring, positive control was run in an independent experiment
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- adopted in 2001
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- adopted in 2003
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- liquid
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Remarks:
- Hsd Win:NMRI
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 3, 10 and 30% (w/v)
- No. of animals per dose:
- 6
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The reliability check with the positive control was done at regular intervals. Data included in the study report were published in 2004 and 2005 by the same authors. The positive control substance alpha-hexyl cinnamic aldehyde (3, 10 and 30% in acetone:olive oil (4:1 v/v)) was considered to be a sensitiser under the conditions of the test.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 0.98
- Test group / Remarks:
- 3%
- Remarks on result:
- other: SI = Cell count of treated group / Cell count of control group
- Parameter:
- SI
- Value:
- 0.88
- Test group / Remarks:
- 10%
- Remarks on result:
- other: SI = Cell count of treated group / Cell count of control group.
- Parameter:
- SI
- Value:
- 1.37
- Test group / Remarks:
- 30%
- Remarks on result:
- other: SI = Cell count of treated group / Cell count of control group.
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin sens. 1, H317 according to Regulation (EC) No. 1272/2008.
- Conclusions:
- A local lymph node assay was performed with the test item at dose levels up to 30%. In the applied protocol, lymph node cell count was used as direct measurement of cell proliferation and a lower cut-off value of 1.4 times increase of stimulation index (SI) was used when compared to the current OECD guideline 429 (2015). A statistically significant increase compared to vehicle control treated animals regarding cell counts was observed in the highest dose group. For the 30% formulation an SI value of 1.37 was obtained, indicating slight skin sensitising properties of the test item. The authors state that, based on the experience with the assay, a small increase in the test item concentration would verify classification as weak sensitiser. In addition, the high dose level was set to 30% because an unspecific activation by irritation was expected at higher concentrations. Based on the experimental findings classification as Skin sens 1, H317 is required according to 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.
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