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EC number: 412-260-6 | CAS number: 52658-19-2 MONO 442
- 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
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:
- From March 04, 2004 to March 22, 2004
- 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:
- Histidine gene in S. typhimurium
Tryptophan gene in E. coli - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-1254 induced rat liver S9-mix
- Test concentrations with justification for top dose:
- Preliminary test: 3-10-33-100-333-1000-3330-5000 μg/plate
First and second test: 33, 100, 333, 1000, 3330 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethyl sulfoxide
- Untreated negative controls:
- yes
- Remarks:
- dimethyl sulfoxide
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9 mix: 5 μg/plate in saline for TA1535
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 mix: 60 μg/plate in milli-Q water for TA1537
- Positive control substance:
- other: daunomycine 4 μg/plate in Saline for TA98
- Remarks:
- without S9 mix
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without S9 mix: methylmethanesulfonate 650 μg/plate in DMSO for TA100
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9 mix: 10 μg/plate in DMSO for WP2 uvr A
- Positive control substance:
- other: 2-aminoanthracene in DMSO for all tester strains
- Remarks:
- with S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48h
NUMBER OF REPLICATIONS: doses of the test substance were tested in triplicate in each strain. Two independent experiments were conducted.
DETERMINATION OF CYTOTOXICITY
- Method: reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies
OTHER EXAMINATIONS:
- Other: precipitation of test substance - Evaluation criteria:
- A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in any tester strain at any concentration is not greater than two times the solvent control value, with or without metabolic activation.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) It induces at least a 2-fold, dose related increase in the number of revertants with respect to the number induced by the solvent control in any of the tester strains, either with or without metabolic activation. However, any mean plate count of less than 20 is considered to be not significant.
b) The positive response should be reproducible in at least one independently repeated experiment. - Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- 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:
- no cytotoxicity, but tested up to precipitating concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Test substance precipitated in the top agar at concentrations of 1000 µg/plate and upwards. Precipitation of test substance on the plates was observed at the start and at the end of the incubation period at the concentration of 3330 µg/plate.
RANGE-FINDING/SCREENING STUDIES:
No toxicity and mutagenicity was observed up to concentrations of 3300 μg/plate
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 - Conclusions:
- Under the study conditions, the test substance is not mutagenic in the S. typhimurium reverse mutation assay and in the E. coli reverse mutation assay.
- Executive summary:
A study was conducted to determine the mutagenic activity of the test substance in theSalmonella typhimuriumandEscherichia colireverse mutation assay (with independent repeat) according to OECD Guideline 471 and EU Method B13/14, in compliance with GLP. The test substance was examined using four strains ofS. typhimurium(TA1535, TA1537, TA100 and TA98) and in WP2uvrA strain ofE. coli. The test was performed in two experiments in the presence and absence of S9-mix. The test substance was dissolved in dimethyl sulfoxide. Based on the results of the dose range finding study, the test substance was tested in the first mutation assay at a concentration range of 33 to 3330 µg/plate in the absence and presence of 5% v/v S9-mix in tester strains TA1535, TA1537 and TA98. In the second mutation assay, the same concentration range was tested in the absence and presence of 10% v/v S9-mix in tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA. Precipitation was observed on the plates at the top dose of 3330 µg/plate. The bacterial background lawn was not reduced at any of the concentrations tested and no decrease in the number of revertants was observed. The test substance did not induce a dose-related increase in the number of revertant (His+) colonies in any of the four tester strains ofS.typhimuriumand in the number of revertant (Trp+) colonies in tester strain WP2uvrA ofE.coliboth in the absence and presence of metabolic activation. These results were confirmed in an independently repeated experiment. In this study, the negative and strain-specific control values were within the laboratory historical control values indicating that the test conditions were adequate and that the metabolic activation system functioned properly. Under the study conditions, the test substance was not considered to be mutagenic in theS. typhimuriumandE. colireverse mutation assay (Verspeek-Rip, 2004).
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro cytogenicity study in mammalian cells or in vitro micronucleus study does not need to be conducted because adequate data from an in vivo cytogenicity test are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity assay: micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Information from migrated NONS file, as per inquiry number 06-0000014943-66-0000, permission to refer granted by ECHA
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
- Route of administration:
- oral: unspecified
- Details on exposure:
- Sesame oil
- Duration of treatment / exposure:
- no data
- Frequency of treatment:
- no data
- Post exposure period:
- no data
- Remarks:
- Doses / Concentrations:
2000 mg/l
Basis:
no data - No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Positive control(s):
- no data
- Tissues and cell types examined:
- no data
- Details of tissue and slide preparation:
- no data
- Evaluation criteria:
- no data
- Statistics:
- no data
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- Doses producing toxicity > 2000 mg/kg b.w.
- Conclusions:
- Under the test conditions the test substance was not mutagenic in Mammalian Erythrocyte Micronucleus Test.
- Executive summary:
A study was conducted to determine the genotoxic potential of the test substance according to OECD Guideline 474, in compliance with GLP. No detailed information about the test method employed and results obtained were provided. The test was conducted in NMRI mice at the test substance concentration of 2000 mg/L. Under the test conditions, the test substance was not considered to be genotoxic in the mammalian erythrocyte micronucleus test (Anonymous, 1993).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Genetic toxicity in vitro:
A study was conducted to determine the mutagenic activity of the test substance in the Salmonella typhimurium and Escherichia coli reverse mutation assay (with independent repeat) according to OECD Guideline 471 and EU Method B13/14, in compliance with GLP. The test substance was examined using four strains ofS. typhimurium(TA1535, TA1537, TA100 and TA98) and in WP2uvrA strain ofE. coli. The test was performed in two experiments in the presence and absence of S9-mix. The test substance was dissolved in dimethyl sulfoxide. Based on the results of the dose range finding study, the test substance was tested in the first mutation assay at a concentration range of 33 to 3330 µg/plate in the absence and presence of 5% v/v S9-mix in tester strains TA1535, TA1537 and TA98. In the second mutation assay, the same concentration range was tested in the absence and presence of 10% v/v S9-mix in tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA. Precipitation was observed on the plates at the top dose of 3330 µg/plate. The bacterial background lawn was not reduced at any of the concentrations tested and no decrease in the number of revertants was observed. The test substance did not induce a dose-related increase in the number of revertant (His+) colonies in any of the four tester strains of S.typhimurium and in the number of revertant (Trp+) colonies in tester strain WP2uvrA of E.coli both in the absence and presence of metabolic activation. These results were confirmed in an independently repeated experiment. In this study, the negative and strain-specific control values were within the laboratory historical control values indicating that the test conditions were adequate and that the metabolic activation system functioned properly. Under the study conditions, the test substance was not considered to be mutagenic in the S. typhimurium and E. coli reverse mutation assay (Verspeek-Rip, 2004).
Genetic toxicity in vivo:
A study was conducted to determine the genotoxic potential of the test substance according to OECD Guideline 474, compliance with GLP. No detailed information about the test method employed and results obtained were provided. The test was conducted in NMRI mice at the test substance concentration of 2000 mg/L. Under the test conditions, the test substance was not considered to be genotoxic in the mammalian erythrocyte micronucleus test (Anonymous, 1993).
Justification for classification or non-classification
Based on the results of in vitro and in vivo studies, the test substance does not warrant classification for genotoxicity according to EU CLP (1272/2008/EC) criteria.
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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