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Registration Dossier
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EC number: 615-063-5 | CAS number: 700863-48-5
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-12-22 to 2006-04-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
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 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002-04-24
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 92/69/EC
- Deviations:
- no
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reference substance 001
- EC Number:
- 616-651-4
- Cas Number:
- 787582-75-6
- Molecular formula:
- C26H2 lF702
- Reference substance name:
- APUQU-2-F
- IUPAC Name:
- APUQU-2-F
- Details on test material:
- Batch: E06000594
Purity: (HPLC): 99.7 % (a/a)
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Strain: Albino rabbit, Crl:KBL (NZW), female (f)
Source: Charles River Wiga GmbH, Kißlegg
Age: Approx. 15 weeks
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Aqua pro injectione
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of the test material mixed with several drops of Aqua pr injectione to ensure good skin contact. Single application
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- The rabbits were examined for skin alterations, behaviour and general condition 1 hour after removal of the patches, after 24, 48 and 72 hours, and then daily up to experimental day 8.
- Number of animals:
- 3 females
- Details on study design:
- Prior to testing the pH of the preparation was determined with pH-test strips. The pH was found to be about 7. After that the test material was screened for its irritating potential using hen's egg test on the chorioallantoic membrane (HET-CAM). In the main study on primary skin irritation, 0.5 g of the test material, was mixed with some drops of Aqua pro injectione and ground in a mortar using a pestle to ensure good contact with the skin. Afterwards, the test material was spread onto 6 cm² patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. The study was started as an initial test with one animal and followed by the confirmatory test with two further animals. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for further 7 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No skin irritating potential could be detected. According to EEC Directive 2001/59 the test item does not have to be classified as a skin irritant.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin irritating potential could be detected. According to CLP the test material should not be classified as a skin irritant.
- Executive summary:
0.5 g of the test material was mixed with several drops of Aqua pro injectione to ensure good skin contact. The initial test with one animal and the confirmatory test with two further animals showed no signs of irritation at the treated areas following single application to the intact dorsal skin of rabbits for 4 hours under semiocclusive conditions. No signs of clinical toxicity were detected. All animals survived the observation period. Body weight development of the treated rabbits was inconspicuous. Under the conditions of the present study no signs of irritation were seen.
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