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EC number: 812-241-6 | CAS number: -
- 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
Genetic toxicity: in vitro
Administrative data
- 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:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Enzymatic hydrolysis products of Ophiopogon japonicus, Liliaceae, root
- EC Number:
- 812-241-6
- Cas Number:
- 952500-62-8
- IUPAC Name:
- Enzymatic hydrolysis products of Ophiopogon japonicus, Liliaceae, root
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: Very clear beige powder
- Storage conditions: Ambient temperature (20±5 °C), keep away from humidity
- Batch No.: 150904-0120
- Production date: 2015-09-04
- Expiry date: 2017-09-04
Constituent 1
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10% S9: S9-mix from the livers of rats
- Test concentrations with justification for top dose:
- Main study - Direct plate incorporation method: 50, 160, 500, 1600 and 5000 μg/plate, with and without S9-mix in TA 1535, TA 1537, TA 98, TA 100 and TA 102 strains
Confirmatory assay - pre-incubation method: 50, 160, 500, 1600 and 5000 μg/plate, with and without S9-mix in TA 1535, TA 1537, TA 98, TA 100 and TA 102 strains - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: The test substance, Cohesium was soluble in water (50 mg/ml).
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- Remarks:
- Without S9-mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- With S9-mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 37 °C for 20-30 minutes
- Exposure duration: Plates were incubated at 37 ± 1 °C for 48-72 h
Each test item dilution and each reference item are tested on 3 Petri plates - Evaluation criteria:
- For each assay the following observations were performed and reported:
- Observation of the reagent mix before Petri plates pouring: reporting of any abnormal sign (precipitate, trouble, etc.),
- Petri plates observation and reporting of any cytotoxicity sign (bottom bacterial layer reduction). The cytotoxicity intensity on the bottom bacterial layer is evaluated qualitatively on each plate by naked eyes: o total destruction of the bottom bacterial layer (the revertants development does not occurs in this
case), this one is noted in tables of results as “A”. o moderated destruction of the bottom bacterial layer. This one is noted in tables of results as “S”.
Acquisition and storage of raw data were managed by the following electronic system:
- Reading of plates: Sorcerer, version 2.2.
- Transfer and storage of raw data: Ames Study Manager, version 1.22.
The result tables edition was managed by the Ames Report Generator, version 1.
The test is considered valid if the following criteria are fulfilled:
- The sterility tests are conform,
- The mean negative controls are within the historical data,The solvent used (negative control) must not show genotoxic nor cytotoxic activity,The revertants rate obtained for the positive controls must be in agreement with the historical data,
- The positive controls must show a revertants number equal at least to the double of the spontaneous rate of reversion for TA98, TA100 and TA102 (R superior or egual to 2) and the triple of the spontaneous rate of reversion for TA1535 and TA1537 (R superior or egual to 3),
- No more than 5% of the plates of the test are lost through contamination or any other unforeseen event,
- At least 3 concentrations are available for mutagenicity assessment
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA98, TA100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- No cytotoxic effect was observed,
No concentration of the test item showed ratio R higher or equal at least to the double of the spontaneous rate of reversion for TA98, TA100 and TA102 strains and to the triple of the spontaneous rate of reversion for TA1535 and TA1537 strains, with and without metabolic activation,
No dose response was observed, whatever the test system or conditions of the test.
In addition, no sign of precipitate was observed.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
At the light of the results obtained during this study, we can conclude that the test item OF14 AT does not show any mutagenic nor pro-mutagenic activity, under the test conditions used. - Executive summary:
In a reverse gene mutation assay in bacteria, performed according to the OECD Guideline 471 and in compliance with GLP, strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA100 and TA102) were exposed to test item, Cohesium at the following concentrations: 50, 160, 500, 1600 and 5000 μg/plate
Metabolic activation system used in this test 10 % S9 mix; S9 fraction prepared from liver homogenates of rats. Vehicle and positive control groups were also included in mutagenicity tests.
The preliminary study showed no cytotoxicity of the test item; therefore this concentrations range was used for the genotoxicity Test 1.
According to the result obtained for the Test 1, the Study Director decided to use the same dilution range for the test 2.
The revertant analysis shows that:
No cytotoxic effect was observed,
No concentration of the test item showed ratio R higher or equal at least to the double of the spontaneous rate of reversion for TA98, TA100 and TA102 and to the triple of the spontaneous rate of reversion for TA1535 and TA1537, with and without metabolic activation,
No dose response was observed, whatever the test system or conditions of the test.
At the light of the results obtained during this study, we can conclude that the test item OF 14 AT - LOT : 150904-0120 does not show any mutagenic nor pro-mutagenic activity, under the test conditions used.
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