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Registration Dossier
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EC number: 216-760-3 | CAS number: 1658-56-6
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from 21st May 2003 to 26th May 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- study performed on the analogue substance; the read across justification is detailed in section 13. The Reliability of the Source Study is 2.
- Justification for type of information:
- The read across justification is detailed in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2002
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol/water (50/50, v/v)
- Concentration:
- 0, 2.5, 5 and 10%
- No. of animals per dose:
- Sixteen females (three treated group and 1 negative control group)
- Details on study design:
- The animals were allocated to four groups of four animals each:
- three treated groups receiving the test item at the concentration of 2.5, 5 or 10%,
- one negative control group of four animals receiving the vehicle (mixtiue ethanol/water (50/50)). - Positive control substance(s):
- not specified
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- Conc. 2.5 and 5 %
- Parameter:
- SI
- Value:
- 1.59
- Test group / Remarks:
- Conc. 10 %
Any other information on results incl. tables
No clinical signs, no mortality and no noteworthy increase in ear thickness were observed during the study.
Conceming the lymphoproliferative response, the incorporation of tritiated methyl thymidine in the treated groups was similar to that of the vehicle control group.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- The test item was found not to be skin sensitizer under experimental conditions.
- Executive summary:
In order to evaluate the skin allergenic potential of the test item, a Local Lymph Node Assay (LLNA) was performed according to the OECD Guideline No. 429 (2002). Three dose levels from 2.5 to 100 % of test item in the vehicle (ethanol/water (50/50, v/v)) and the vehicle alone as negative control were administered to sixteen female CBA/J allocated to four groups of four animals each.
The calculated Stimulation Index were 1.1 at the two low doses and 1.59 at the high dose. Thus, the test item should not be considered as a skin sensitizer under the experimental conditions and according to the followed OECD Guideline No. 429.
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