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Diss Factsheets
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EC number: 478-310-4 | CAS number: 53803-13-7
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Vehicle:
- other: ethanol/distilled water 7:3
- Concentration:
- 5% - 10% - 25%
- No. of animals per dose:
- 4
- Details on study design:
- Following a preliminary screening test in which clinical signs of toxicity were noted at a concentration of 50% w/w but not at a concentration of 25% w/w, 25% w/w was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 ul. (25 ul. per ear) of the test item as a solution in ethanol/distilled water 7:3 at concentrations of 25%, 10% or 5% w/w. A further group of four animals was treated with ethanol/distilled water 7:3 alone.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- Stimulation index for positive control substance was 18.54 so substance is considered sensitizer
- Parameter:
- SI
- Remarks on result:
- other: Concentration 5% - 1.3 Concentration 10% - 2.03 Concentration 25% - terminated due to toxicity
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: See attached table 4
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 5% w/w Concentration in ethanol/distilled water 7:3
- Parameter:
- SI
- Value:
- 2.03
- Test group / Remarks:
- 10% w/w/ concentration in ethanol/distilled water 7:3
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid is considered to be non-sensitizer under the consitions of LLNA study.
- Executive summary:
Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid is considered to be non-sensitizer under the consitions of LLNA study.
Reference
In the group treated with the test item at a concentration of 25% w/w in ethanol/distilled water 7:3, one animal was found dead and one animal developed signs of toxicity and was humanely killed on Day 3. The other two animals within the group were killed humanely as there were not enough animals remaining in the group to provide a result. No deaths or signs of systemic toxicity were noted in the remaining test or control animals during the test.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Migrated from Short description of key information:
Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid is considered to be non-sensitizer under the consitions of LLNA study.
Justification for classification or non-classification
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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