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EC number: 234-933-1 | CAS number: 12042-91-0
- 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:
- 22-April-2010 to 10-May-2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- 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
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): 202240/A
- Physical state: solid, white crystalline powder
- Expiration date of the lot/batch: 13 December 2010
- Storage condition of test material: At room temperature in the dark
- Stability under storage conditions: Stable
Constituent 1
Method
- Target gene:
- - S. typhimurium: Histidine gene
- E. coli: Tryptophan gene
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone
- Test concentrations with justification for top dose:
- Experiment 1:
Preliminary test (without and with S9) TA100 and WP2uvrA: 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate
Main study: TA1535, TA1537 and TA98:
Without and with S9-mix: 100, 333, 1000, 3330 and 5000 µg/plate
Experiment 2:
TA1535
Without S9-mix: 33, 100, 333, 1000 and 3330 µg/plate
TA1537
Without and with S9-mix: 10, 33, 100, 333 and 1000 µg/plate
TA98
Without S9-mix: 10, 33, 100, 333 and 1000 µg/plate
Experiment 3
TA1535
Without S9-mix: 33, 100, 333, 1000 and 3330 µg/plate
With S9-mix: 100, 333, 1000, 3330 and 5000 µg/plate
TA1537
Without and with S9-mix: 10, 33, 100, 333 and 1000 µg/plate
TA98
Without S9-mix: 3, 10, 33, 100, 333 and 1000 µg/plate
With S9-mix: 100, 333, 1000, 3330 and 5000 µg/plate
TA100 and WP2uvrA
Without and with S9-mix: 100, 333, 1000, 3330 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: The test substance was dissolved in Milli-Q water.
- Justification for choice of solvent/vehicle: Test compound was soluble in water and water has been accepted and approved by authorities and international guidelines
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene in DMSO
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hour
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain. Three independent experiments were conducted.
NUMBER OF CELLS EVALUATED: 10E8 per plate
DETERMINATION OF CYTOTOXICITY
- Method: The reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies.
OTHER EXAMINATIONS:
- The presence of precipitation of the test compound on the plates was determined. - Evaluation criteria:
- A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is not greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive if:
a) A two-fold (TA100) or more or a three-fold (TA1535, TA1537, TA98, WP2uvrA) or more increase above solvent control in the mean number of revertant colonies is observed in the test substance group.
b) In case a repeat experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one independently repeated experiment.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- 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:
- cytotoxicity
- 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:
- cytotoxicity
- 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:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed up to and including the top dose of 5000 µg/plate
RANGE-FINDING/SCREENING STUDIES:
- Toxicity was observed at dose levels of 3330 μg/plate and above in the absence of S9-mix in tester strain TA100. Toxicity was observed at the dose level of 5000 μg/plate in the presence of S9-mix in tester strain TA100 and in the absence and presence of S9-mix in tester strain WP2uvrA. of
COMPARISON WITH HISTORICAL CONTROL DATA:
- The negative and strain-specific positive control values were within our laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
TA1535: without and with S9: 3330 µg/plate and above
TA1537: without and with S9: 1000 µg/plate and above
TA98: without S9: 333 µg/plate and above and with S9: 3330 µg/plate and above
TA100: without and with S9: 3330 µg/plate and above
WP2uvrA: without and with S9: 5000 µg/plate
Any other information on results incl. tables
Since in the tester strains TA1535 and TA98 in the absence of S9-mix and in TA1537 in the absence and presence of 5% (v/v) S9-mix in the first experiment too many dose levels with toxicity were tested, this part of the experiment was repeated (experiment 2).
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, 202240/A is not mutagenic in Salmonella typhimurium TA100, TA1535, TA1537 and TA98 and Escherichia coli WP2uvrA in the absence or in the presence of metabolic activation.
- Executive summary:
A bacterial reverse mutation assay (Ames Test) was performed according to the OECD guideline No. 471 and in compliance with GLP. The test material 202240/A was tested in Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) and in Escherichia coli (WP2uvrA). The test was performed in three independent experiments in the presence and absence of S9-mix (phenobarbital and ß-naphthoflavone-induced rat liver S9). The dose range finding study was reported as part of Experiment 1.
- Dose range finding:
TA100 and WP2uvrA : up to 5000 µg/plate with and without S9 mix (5%)
- Experiment 1:
TA1535, TA1537, TA98: up to 5000 µg/plate with and without S9 mix (5%)
- Experiment 2:
TA1535: up to 3330 µg/plate without S9 mix
TA1537: up to 1000 µg/plate with and without S9 mix (3.6%)
TA98: up to 1000 µg/plate without
- Experiment 3:
TA1535: up to 3330 µg/plate without S9 mix ; up to 5000 µg/plate with S9 mix (10%)
TA1537: up to 1000 µg/plate with and without S9 mix (10%)
TA98: up to 1000 µg/plate without S9 mix ; up to 5000 µg/plate with S9 mix (10%)
TA100 and WP2uvrA: up to 5000 µg/plate with and without S9 mix (10%).
202240/A did not precipitate on the plates at the highest dose levels.
Toxicity was observed in all tester strains in all experiments. Since in the strains TA1535 and TA98 in the absence of S9-mix and in tester strain TA1537 in the absence and presence of S9-mix too many dose levels with toxicity were tested, this part of the experiment was repeated in mutation experiment 2.
202240/A did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in two independently repeated experiments.
In this study, the negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Under the test conditions, 202240/A is not mutagenic in Salmonella typhimurium TA100, TA1535, TA1537 and TA98 and Escherichia coli WP2uvrA in the absence or in the presence of metabolic activation.
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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