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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-718-0 | 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
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 20.1.2011 - 4.4.2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted according to OECD Guideline under GLP conditions.
- 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
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Not specified
- 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:
- Rat liver homogenate (10% liver S9 in standard co-factors)
- Test concentrations with justification for top dose:
- Rangefinding test: 1.5 to 5000 micro g/plate -S9; 5 to 5000 micro g/plate +S9
Main test: 0.5 to 5000 micro g/plate -S9; 5 to 5000 micro g/plate +S9 - Vehicle / solvent:
- Dimethyl sulphoxide
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Details on test system and experimental conditions:
- Tester Strains
The four strains of Salmonella used in the test were obtained from the University of California, Berkeley, on culture discs, on 4 August 1995 and Syngenta CTL, Alderly Edge, as frozen vials, on 20 March 2007. Escherichia coli strain WP2uvrA was obtained from the British Industrial Biological Research Association on 17 August 1987. All of the strains were stored at approximately -196 degrees Centigrade in a Statebourne liquid nitrogen freezer, model SXR 34.
In this assay, overnight sub-cultures of the appropriate coded stock cultures were prepared in nutrient broth and incubated at 37 degrees Centigrade for approximately 10 hours. Each culture was monitored spectrophotometrically for turbidity with titres determined by viable count analysis on nutrient agar plates.
Preparation of Test and Reference Items
The test item was immiscible in sterile distilled water and acetone at 50 mg/ml but was fully miscible in dimethyl sulphoxide at the same concentration in solubility checks performed in-house. Dimethyl sulphoxide was therefore selected as the vehicle.
The test item was accurately weighed and approximately half-log dilutions prepared in dimethyl sulphoxide by mixing on a vortex mixer and sonication for 10 minutes at 40 degreesCentigrade on the day of each experiment. All formulations were used within four hours of preparation and were assumed to be stable for this period.
Prior to use, the solvent was dried to remove water using molecular sieves i.e. 2 mm sodium alumino-silicate pettets with a nominal ore diameter of 4 x 10-4 microns.
Microsomal Enzyme Fraction
The S9 Microsomal fraction was prepared in-house (24 October 2010) from rats induced with Phenobarbitone/beta-Naphthoflavone at 80/100 mg/kg/day, orally, for 3 days prior to preparation on day 4. The S9 homogenate was produced by homogenising the liver in a 0.15 KCl solution (1 g liver to 3 ml KCl) followed by centrifugation at 9000 g. The protein content of the resultant supernatant was adjusted to 20 mg/ml. Aliquots of the supernatant were frozen and stored at approximately -196 degrees Centigrade. Prior to use, each batch of S9 was tested for its capability to activate known mutagens in the Ames test.
S9-Mix and Agar
The S9-mix was prepared immediately before use using sterilised co-factors and maintained on ice for the duration of the test.
S9
1.65 M KCl/0.4 M MgCl2 5.0 ml
0.1 M Glucose-6-phosphate 1.0 ml
0.1 M NADP 2.5 ml
0.2 M Sodium phosphate buffer (pH 7.4) 25.0 ml
Sterile distilled water 14.5 ml
A 0.5 ml aliquot of S9- mix and 2 ml of molten, trace histidine or tryptophan supplement, top agar were overlaid onto a sterile Vogel-Bonner Minimal agar plate in order to assess the sterility of the S9-mix. This procedure was repeated, intriplicate, on the day of each experiment.
Top agar was prepared using 0.6% Bacto agar and 0.5% sodium chloride with 5 ml of 1.0 mM histidine and 1.0 mM biotin or 1.0 mM tryptophan solution added to each 100 ml of top agar. Vogel-Bonner Minimal agar plates were purchased from ILS Ltd. - Evaluation criteria:
- There are several criteria for determining a positive result. Any, one, or all of the following can be used to determine the overall result of the study:
1. A dose-related increase in mutant frequency over the dose range tested.
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. Statistical analysis of data as determined by UKEMS.
5. Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response).
A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met. - Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Preliminary Toxicity Test
The test item induced toxicity to TA100, initially from 500 micro g/plate and to WP2uvrAfrom 1500 micro g/plate. The test item formulation and S9-mix used in this experiment were both shown to be sterile.
Mutation Test
In the first experiment (plate incorporation method) the test item caused a visible reduction in the growth of the bacterial background lawns of all of the Salmonella tester strains (except TA98 dosed with S9-mix), initially from 150 micro g/plate (absence of S9-mix) and 1500 micro g/plate (presence of S9-mix). In the second experiment (pre-incubation method) the test item induced a stronger toxic response to the bacterial background
lawns of all of the Salmonella strains, with toxicity initially observed from 50 micro g/plate (absence of S9-mix) and 500 micro g/plate (presence of S9-mix). Weakened bacterial background lawns were not observed for Escherichia coli strain WP2uvrA at any test item dose level in either experiment. The sensitivity of the tester strains to the toxicity of the test item varied between strain type, exposures with or without S9-mix and experiment number. The test item was, therefore, tested up to either the maximum recommended dose level of 5000 micro g/plate or the toxic limit, depending on bacterial strain type and Experiment number. A test item precipitate (oily in appearance) was observed at 5000 micro g/plate, this observation did not prevent the scoring of revertant colonies.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation or exposure method.
All of the reference items (positive control chemicals) used in the test induced marked increases in the frequency of revertant colonies thus confirming the activity of the S9-mix and the sensitivity of the bacterial strains. - Conclusions:
- Interpretation of results (migrated information):
negative
In an OECD 471 study ("Bacterial Reverse Mutation Test"), conducted according to GLP, reaction mass of bis(C11-14-alkyl, branched and linear)amine nonadecaoxo hexatungstate (the surrogate substance) is non-mutagenic (Harlan Laboratories Ltd., 2011).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Bacteria gene mutation
In an OECD 471 study ("Bacterial Reverse Mutation Test"), conducted according to GLP, reaction mass of bis(C11-14-alkyl, branched and linear)amine nonadecaoxo hexatungstate (the surrogate substance) is non-mutagenic (Harlan Laboratories Ltd., 2011).
Justification for selection of genetic toxicity endpoint
Completed to OECD Guideline and GLP.
Justification for classification or non-classification
Based on the negative outcome of the Ames assay on the test substance it can be concluded that it is not mutagenic, therefore, according to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures the substance is not classified.
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.