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EC number: 265-479-2 | CAS number: 65122-08-9
- 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
The substance was tested in an Ames test in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 102 with and without metabolic activation (Eurofins 2018). The maximum concentration tested was limited mainly by a reduction in the number of revertants down to a mutation factor of approximately ≤ 0.5 of solvent control. In two independent experiments no biologically relevant increase in revertant colony numbers of any of the five tester strains was observed. Therefore the substance is considered non-mutagenic.
In an additional Ames test (plate incorporation) with Salmonella typhimurium strains TA98, TA100, TA1535 and TA 1537, no mutagenic effects were found in presence and absence of metabolic activations (Bayer 1981). The number of concentrations evaluated was limited and positive controls were in some cases only marginally positive. It can be concluded that under the conditions of the test the substance did not induce mutagenic effects in bacteria.
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:
- 21 November 2017 to 12 January 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: TA 98, TA 1535 and TA 102 MOLTOX, INC., NC 28607, USA; TA 100 and TA 1537 Xenometrix AG, Switzerland.
- Methods for maintenance in cell culture if applicable: stock cultures stored with nutrient broth (OXOID) supplemented with DMSO (approx. 8% v/v) over liquid nitrogen - Metabolic activation:
- with and without
- Metabolic activation system:
- liver microsomal fraction from rats treated with phenobarbital / β-naphthoflavone
- Test concentrations with justification for top dose:
- exp 1 :
0.100, 0.316, 1.00, 3.16, 10.0, 31.6, 100 and 316 nL/plate or TA 100, TA 1535 and TA 1537 (with and without metabolic activation),for TA 98 and 102 (without metabolic activation)
3.16, 10.0, 31.6, 100, 316, 100, 316 and 1000 nL/plate for TA98 and TA 102 with metabolic activation
exp 2
0.050, 0.158, 0.50, 1.58, 5.0, 15.8, 50.0, 158 and 500 nL/plate for all strains with and without metabolic activation
Top doses limited by cytotoxicity (reduction of bacterial background lawn or reduction in the number of revertants down to a mutation factor of approximately ≤ 0.5 of solvent controls) - Vehicle / solvent:
- Aqua destillata (purified water)
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine; 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation (Due to severe toxicity of the test item, the confirmatory experiment is carried out according to the plate incorporation method with a different spacing between dose levels)
DURATION
- Preincubation period: NA
- Incubation time: at 37 °C for at least 48 h in the dark
NUMBER OF REPLICATIONS: 3/concentration
DETERMINATION OF CYTOTOXICITY
- Method: reduction of bacterial background lawn or reduction in the number of revertants down to a mutation factor of approximately ≤ 0.5 of solvent control - Evaluation criteria:
- A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs
in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher
than the reversion rate of the solvent control - Statistics:
- NA
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 100 nL/plate and 15.8 nL/plate in exp 1 and 2
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 31.6 and 50 nL/plate in exp 1 and 2
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 100 and 15.8 nL/plate in exp 1 and 2
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 100 and 158 nL/plate in exp 1 and 2
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 316 and 15.8 nL/plate in exp 1 and 2
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 100 nL/plate and 500 nL/plate in exp 1 and 2
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 100 and 158 nL/plate in exp 1 and 2
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 100 and 50 nL/plate in exp 1 and 2
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 100 and 158 nL/plate in exp 1 and 2
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 15.8 and 500 nL/plate in exp 1 and 2
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- The substance is considered non-mutagenic under the conditions of the test.
- Executive summary:
The substance was tested in an Ames test in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 102 with and without metabolic activation. The maximum concentration tested was limited mainly by a reduction in the number of revertants down to a mutation factor of approximately ≤ 0.5 of solvent control. In two independent experiments no biologically relevant increase in revertant colony numbers of any of the five tester strains was observed. Therefore the substance is considered non-mutagenic.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the information available the substance does not need to be classified for mutagenicity according to REGULATION (EC) No 1272/2008.
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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