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Diss Factsheets
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EC number: 247-865-2 | CAS number: 26638-53-9
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- The study was carried out based on the guidelines described in:
OECD, Section 4, Health Effects, No.429 (2010),
EC, No 440/2008; B42: "Skin Sensitization: Local Lymph Node Assay"
EPA, OPPTS 870.2600 (2003) “Skin Sensitization”. - Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J mice
- Sex:
- female
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- 5 females
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- No. of animals per dose:
- 20 females (5 females per group)
Group 1: 0% w/w
Group 2: 10% w/w
Group 3: 25% w/w
Group 4: 50% w/w
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- ca. 1.3
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- ca. 1.4
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- >= 1.5 - <= 3.1
- Test group / Remarks:
- 50%
Any other information on results incl. tables
Skin reactions / Irritation
No irritation of the ears was observed in any of the animals examined.
Systemic toxicity (Body weights
No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. The body weight loss noted for a few animals was considered not toxicologically significant since the changes were slight in nature and no concentration-related incidence was apparent.
Macroscopy of the auricular lymph nodes and surrounding area
The majority of auricular lymph nodes were considered normal in size, except for both nodes in two animals at a 50% test substance concentration (nos. 18 and 19) which appeared larger in size when compared to the other treated groups. No macroscopic abnormalities of the surrounding area were noted in any of the animals.
Radioactivity measurements
Mean DPM/animal values for the experimental groups treated with test substance concentrations 10 and 25% were 428 and 472 DPM respectively. The mean DPM/animal value at a 50% test substance concentration was 507 DPM (when one high value was excluded) or 1049 (without exclusion of the high value). The mean DPM/animal value for the vehicle control group was 341 DPM.
The DPM value for one animal at a 50% concentration (no. 18) was determined to be an outlier at a significance level of 0.05 but not at p 0.01.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The SI values calculated for the substance concentrations 10 and 25% were 1.3 and 1.4, respectively. The SI value calculated for the 50% test substance concentration was 1.5 (when one high value was excluded) or 3.1 (without exclusion of the high value). Upon excluding the high DPM value of one animal at 50%, the mean SI over the dose groups did not show a meaningful increase (1.3 at 10% to 1.5 at 50%). The Grubb’s outlier test showed that this value was an outlier (at p 0.05 but not at p 0.01). Also, 3 out of 5 DPM values at a 50% test substance concentration were essentially within the DPM range encountered over the other dose groups.
Based on these results it was considered that there was no indication that the test substance elicits an SI ≥ 3 when tested up to 50%. 1574 CETONA was therefore considered not to be a skin sensitizer, and it was established that the EC3 value (the estimated test substance concentration that will give a SI =3) (if any) exceeds 50%.
The six-month reliability check with Alpha-hexylcinnamicaldehyde indicates that the Local Lymph Node Assay as performed at WIL Research Europe is an appropriate model for testing for contact hypersensitivity.
Based on these results, 1574 CETONA would not be regarded as a skin sensitizer according to the recommendations made in the test guidelines. The test substance does not have to be classified and has no obligatory labelling requirement for sensitization by skin contact according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) and the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
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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