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EC number: 240-851-7 | CAS number: 16830-15-2
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Based on the result of this study, the test item, ID-11/01446 was found to be non mutagenic and non pro-mutagenic under the test conditions.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25/05/2011 - 17/06/2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- His D, His G, His C
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- The choice of strains is made according to OCDE Guideline. It is five strains of Salmonella typhimurium LT2.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- The solubility test did not show any insolubility of the test item. Therefore, the maximal concentration retained is 5000 μg/plate.
According to OCDE guideline, 5 concentrations of the test item have been studied with approximately half log interval, according to OCDE Guidelines. These doses (rounded to higher value) used for the preliminary cytotoxicity test are therefore the following: 5000, 1600, 500, 160 and 50 μg/plate.
As the preliminary experiment didn't reveal cytotoxicity of the test item, this range of concentrations has been conserved for the test 1.
According to the results obtained in the test 1, the Study Director decided to maintain range of concentrations for Test 2.
Each test dilution and each reference item are tested on 3 Petri plate. - Vehicle / solvent:
- The most commonly used solvent are deionized water for the analyze and the dimethylsulfoxide (DMSO), or any appropriate solvent compatible with the test system and the test item or other solvent can be used at the request of the Sponsor if they are known or if it has been demonstrated that they are not cytotoxic nor genotoxic. The compatibility with the test item is therefore under the Sponsor responsability.
A preliminary dissolution of the test item is prepared in DMSO (DMSO final concentration 3.85%).
The other tested solutions will be obtained by serial dilution from this stock solution. These solutions are prepared extemporaneously each day of manipulation. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: amino-2-anthracène
- Details on test system and experimental conditions:
- Media and growth conditions:
For each experiment, the test strains cultures are prepared in nutrient broth from frozen stocks and incubated at 37°C+/-1°C on shaken platter to allow the culture to grow up to the late exponential or early stationary phase of growth (approximately 10^8-10^9 cells/ml). The optical density of each culture will be used to check the cell density. Each strain of the test system is tested in triplicate with and without metabolic activation system.
Microbial suspension is put in contact with the test item or positive controls, mixed with top agar and poured over minimal agar medium plate. After, solidification, plates are incubated at 37°C +/- 1 °C during 48 to 72 hours. Positive and negative controls are included in the experiment. - Evaluation criteria:
- Acceptance criteria of data:
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 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 and the triple of the spontaneous rate of reversion for TA1535 and TA1537
-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 - Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no mutagenic potential (based on QSAR/QSPR prediction)
- Conclusions:
- Based on the result of this study, the test item, ID-11/01446 was found to be non mutagenic and non pro-mutagenic under the test conditions.
- Executive summary:
Study summary
The ability of the test item supplied by PHYCHER BIODEVELOPPEMENT, to induce mutation was assessed using the bacterial reverse mutation test (Ames test). The test was performed on five Salmonella typhimurium strains.
The test item dilutions were prepared in DMSO.
A preliminary cytotoxicity test was performed on S.typhimurium TA100 strain.
The test is performed at the concentrations 5000, 1600, 500, 160, 50 μg/plate, with and without S9.
The preliminary study did not shown any cytotoxicity of the test item, therefore this concentration 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 analyse show 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 TA153, with and without metabolic activation.
-no dose response was observed, whatever the test system or conditions of the test.
-however, signs of precipitate were observed during test 2 on concentration 5000 μg/plate without metabolic activation.
At the light of the results obtained during this study, we can conclude that the test item does not show any mutagenic nor pro-mutagenic activity, under the test conditions used.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
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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