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Diss Factsheets
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EC number: 807-137-2 | CAS number: 110528-94-4
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Only a screening test at one concentration of 5 mg/plate as a 5% solution of the 70% product. This is approx 0.2 mg/plate (200 µg) actives. Only a single experiment was performed
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- Principles of method if other than guideline:
- The purpose of this protocol is to evaluate the ability of a chemical, formulation or extract to induce a mutagenic response in five different strains; namely Salmonella typhimurium, namely TA 97a, TA98, TA 100, TA 102, TA 1535. Test materials are screened at different dose levels by plating them with the tester strains both with and without Aroclor™ 1254 induced rat liver microsomes (59). Materials are considered mutagenic if they
cause an increase in revertant colonies above the spontaneous background (i.e. no test material) level. - GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Details on test system and experimental conditions:
- In this protocol, a complete set of positive and negative controls is included with each assay, and is plated routinely with all of the tester strains.
Aroclor™ 1254 induced rat liver microsomes are included to mimic the in vivo activity of the liver enzymes in activating some pro"mutagens to mutagenic status. This method is compliant with the OECD TG 471, Bacterial Reverse Mutation Test (1997) guidance document. - Species / strain:
- S. typhimurium, other: Salmonella typhimurium TA97a, S. typhimurium TA 98, S. typhimurium TA100, S. typhimur ium TA102, S. typhimurium TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- none detected
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
The results show that the test strains are sensitive to the positive control mutagens and had a spontaneous reversion rate well within the accepted values of each strain, indicating that under the test conditions, the strains were sensitive to the detection of potentially genotoxic agents.
The metabolic activation using the S9 activation mixture shows an active microsomal preparation.
Using the same test conditions, there was no detectable genotoxic activity associated with the single test concentration of ColaMoist 200, 5% aqueous Lot #: 10756B05, neither in the absence or presence of the S9 enzyme activation, at the foHowing concentrations: 5 milligrams/plate of test material, which equates to 250 micrograms / plate of active ingredient.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Supporting studies for a similar substance, (choline chloride CAS 67 -48 -1), gave the following conclusions in an OECD SIDS report from 2004;
Choline chloride does not have any structural alerts for genotoxicity. It did not produce gene mutations, clastogenicity or DNA damage when tested in vitro. It can be concluded from these studies that choline chloride does not have any mutagenic potential.
Choline chloride (CAS 67-48-1) is a similar short chain quaternary amine of similar properties to ColaMoist 200. The structure of ColaMoist 200 is equivalent to a dimer of choline chloride joined through a OH-C-H linkage. Groupings are similar and therefore toxicological propertes might be expected to be similar too although cannot be confirmed.
Justification for selection of genetic toxicity endpoint
Only valid study report on the actual substance, ColaMoist 200, avaialable for this end point.
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.
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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