Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 946-342-2 | 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Mutagenicity refers to the induction of permanent transmissible changes in the amount or structure of the genetic material of cells or organisms. The Bacterial Reverse Mutation Test (OECD 471, EU B.13/14) detects gain of function point mutations and frameshifts in vitro, and is required to fulfil REACH Annex VII information requirements. Under the test conditions, the test item did not present any mutagenic properties in the Bacterial Reverse Mutation Test. The test item did not induce a significant increase in the mutation frequency of Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA102 at concentrations up to 5000 µg/plate in the presence and 1500 µg/plate in the absence of a metabolising system. Conducted according to the aforementioned guidelines and GLP, the Ames Test passed all validity criteria and was considered to be reliable without restriction (Klimisch 1).
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:
- 28 March 2000 - 23 June 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Column 1 of REACH Annex VII informs on the standard mutagenicity information requirements, for substances produced or imported in quantities >1 tpa. The Bacterial Reverse Mutation Test (OECD 471) detects gain of function point mutations and frameshifts in vitro, and is required to fulfil Annex VII information requirements.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- The Salmonella typhimurium histidine (his) reversion system is a microbial assay which measures mutation in the histidine operon. Gain of function his- to his+ mutation is induced by chemicals which cause base changes or frameshift mutations in the genome of this organism. S. typhimurium strains TA98 and TA1537 primarily respond to frameshift mutations at the histidine gene locus his D 3052 and his C 3076, respectively. Strains TA100, TA102 and TA1535 respond to base-pair substitutions in the his G 46, his G 428 and his G 46 locus.
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- other: rfa
- Remarks:
- loss of the outer lipopolysaccharide barrier
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver homgenate (S9)
- Test concentrations with justification for top dose:
- 15, 50, 150, 500, 1500 and 5000 µg per plate. In the presence and absence of S9-mix the test item was bacteriotoxic towards strain TA102 at 5000 μg/plate. Precipitation of the test compound an the plates was observed at 1500 and 5000 μg/plate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- CELLS USED
- Source of cells: Dr. Bruce N. Ames, University of California, Berkeley, California, U.S.A.
- Suitability of cells: All tester strains except the strain TA102 contain a uvrB- mutation, which causes loss of the excision repair system, and greatly increases the sensitivity of the test for detecting of many mutagens.
- Methods for maintenance in cell culture if applicable: Master plates are used as a source of bacteria for inoculating the overnight cultures and are always kept at 4°C and discarded alter one month or sooner if the number of spontaneous revertants per plate falls out of the normal range specific for a strain. The tester strain cultures used in this study were grown in Oxoid nutrient broth No.2 (2.5%) on a shaker at 37°C for 11-12 hours to a density of 1E9 to 3E9 cells per mL. They were then kept at 4°C. Only fresh cultures are used for mutagenicity assays.
MEDIA USED
- Type and identity of media: Agar, 1.5%; Difco bacto nutrient broth, 0.8%; NaCl, 0.5%
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: no
- Periodically 'cleansed' against high spontaneous background: no
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 to 72 hours
NUMBER OF REPLICATIONS: 3 - Evaluation criteria:
- Number of spontaneous revertant colonies (his+ revertants)
- Statistics:
- Estimation of the statistical significance of the difference between the mean number of revertants in the negative controls and the plates at each dosage level was calculated using a X2-test (Mohn & Ellenberger, 1977).
- 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:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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:
- not applicable
- 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:
- cytotoxicity
- Remarks:
- Bacteriotoxic at 5000 µg/plate
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation of the test compound an the plates was observed at 1500 and 5000 µg/plate
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: TA1535 (-S9: 31±11, range 13-58; +S9: 19±6, range 9-27), TA1537 (-S9: 11±4, range 5-20; +S9: 16±5, range 9-29), TA98 (-S9: 30±8, range 18-47; +S9: 40±10, range 21-63), TA100 (-S9: 150±35, range 89-226; +S9: 139±38, range 88-238), TA102 (-S9: 280±37, range 218-359; +S9: 306±45, range 237-400)
- Negative (solvent/vehicle) historical control data: TA1535 (-S9: 30±11, range 10-62; +S9: 18±6, range 9-28), TA1537 (-S9: 11±4, range 6-21; +S9: 16±5, range 9-29), TA98 (-S9: 29±8, range 19-50; +S9: 38±9, range 23-62), TA100 (-S9: 138±29, range 94-205; +S9: 133±38, range 79-222), TA102 (-S9: 269±38, range 163-337; +S9: 298±46, range 207-404) - Conclusions:
- Mutagenicity refers to the induction of permanent transmissible changes in the amount or structure of the genetic material of cells or organisms. The Bacterial Reverse Mutation Test (OECD 471, EU B.13/14) detects gain of function point mutations and frameshifts in vitro, and is required to fulfil REACH Annex VII information requirements. Under the test conditions, the test item did not present any mutagenic properties in the Bacterial Reverse Mutation Test. Conducted according to the aforementioned guidelines and GLP, the Ames Test passed all validity criteria and was considered to be reliable without restriction (Klimisch 1).
- Executive summary:
An Ames test was conducted on the test item using Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA102 (King 2000). The test was performed by the plate incorporation assay at test item concentrations of 15, 50, 150, 500, 1500 and 5000 µg/plate in the presence of S9 and 50, 150, 500, 1500 and 5000 µg/plate in the absence of S9, alongside negative, solvent and positive controls. The test item was incubated for 48 to 72 hours and mutagenicity was assessed based on the number of revertant colonies. The test item was not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA102 in the presence and absence of a metabolising system. In the presence and absence of S9-mix the test item was bacteriotoxic towards the strain TA102 at a concentration of 5000 µg/plate. The study is reliable without restriction (Klimisch 1) as it was GLP-compliant and was conducted according to OECD Guideline 471.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
An Ames test was conducted on the test item using Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA102 (2000). The test was performed by the plate incorporation assay at test item concentrations of 15, 50, 150, 500, 1500 and 5000 µg/plate in the presence of S9 and 50, 150, 500, 1500 and 5000 µg/plate in the absence of S9, alongside negative, solvent and positive controls. The test item was incubated for 48 to 72 hours and mutagenicity was assessed based on the number of revertant colonies. The test item was not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA102 in the presence and absence of a metabolising system. In the presence and absence of S9-mix the test item was bacteriotoxic towards the strain TA102 at a concentration of 5000 µg/plate. The study is reliable without restriction (Klimisch 1) as it was GLP-compliant and was conducted according to OECD Guideline 471.
Justification for classification or non-classification
The Bacterial Reverse Mutation Test (OECD 471, EU B.13/14) detects gain of function point mutations and frameshifts in vitro, and is required to fulfil Annex VII information requirements. One key study (Klimisch 1) is available for classification (2000) of genotoxicity. The test item did not induce a significant increase in mutation frequency in Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA102 at doses up to 5000 µg/plate in the presence and absence of S9. Therefore, the test item is not considered to be mutagenic.
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.