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EC number: 485-110-0 | CAS number: 53535-81-2
- 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:
- from 2008-03-05 to 2008-03-11
- Reliability:
- 1 (reliable without restriction)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2004/73/EC
- Deviations:
- no
- Principles of method if other than guideline:
- no other principles
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Age of animals : Young adult, 11-12 weeks old, age-matched within one week
Body weight range at starting : The weight variation in animals involved in the study did not exceed > 20 % of the mean weight.
Acclimatisation time: 35 days
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- NA
Challenge
- Concentration / amount:
- NA
- No. of animals per dose:
- NA
- Details on study design:
- NA
- Challenge controls:
- NA
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 5;10;25 % (w/v) (25µl)
- No. of animals per dose:
- 4
- Details on study design:
- Three groups of female mice strain CBA/Ca Ola Hsd, each of five animals, received the appropriate formulation of LTA at concentrations 5 %, 10 % and 25 %. The negative control group received the solvent dimethyl formamide (DMF), the positive control group received. alpha.-Hexylcinnamaldehyde (HCA) dissolved in DMF at a concentration of 25%. Test sand control substance were applied on the external surface of each ear (25.mu.L/ear)for threeconsecutive days at the appropriate concentrations. On day 5, the cell proliferation in the local lymph nodes was measured by incorporation of
tritiated methyl thymidine (3H-methyl thymidine) and the values obtained were used to calculate stimulation indices (SI). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- NA
Results and discussion
- Positive control results:
- The positive control substance alpha-Hexylcinnamaldehyde (HCA) was examined at a concentration of 25 % in DMF. Significant lymphoproliferative response (SI >= 3) was noted for the standard positive control (HCA) with an SI value of 8.5 demonstrating the appropriate performance of the assay. This value is not significantly different to the historic controls.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Proliferation assays were conducted for all three concentrations of the test item (25 %, 10 % and 5 %). However, the 25 % group data were excluded from data analysis because the skin damage which persisted until study termination was an effect incompatible with the LLNA as it would have allowed an immuno-response against bacteria at the site of damaged skin. This immuno-response would include proliferation in the lymph node. No lymphoproliferative response (SI >= 3) was noted for Lithium-tert-amoxide (LTA) at the applied concentrations of 10 % or 5 %. Stimulation index values (SI) were 0.9 and 0.9 at concentrations of 10 % and 5 %, respectively.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: NA
Any other information on results incl. tables
Clinical signs and mortality:
No mortality or systemic toxicity was observed during the study Signs of minor irritation (red skin and some lesions) were observed in the 25 % test item treated group prior to the third treatment, it was visible at the base of the ears; on day 3 it was relatively mild and was not considered to be causing any animal suffering. However, the lesions did not recover; the skin surface remained broken until study termination. The pH values of formulations on the third day of dosing were measured and found to be 9.99, 9.48 and 7.71 for 25 %, 10 % and 5 % formulations, respectively.Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information criteria: EU
- Conclusions:
- Under the conditions of the present assay Lithium-tert-amoxide, tested as a biologically compatible formulation up to the maximum feasible concentration (10 %) in an appropriate solvent was shown to have no sensitisation potential in the Local Lymph Node Assay.
- Executive summary:
No mortality or systemic clinical signs and no treatment related effect on body weights were observed during the study. Irritation including skin integrity damage was observed in the 25 % test item treated group at the base of the ears of all animals and persisted until study termination.
The test material was considered to be a non-sensitiser.
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