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EC number: 600-687-2 | CAS number: 105839-18-7
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 21 August 2012 to 4 December 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Fully GLP compliant and in accordance with current test guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- other: yellow/brown liquid
- Details on test material:
- Name: MonoFA_TETA_PAA_BADGE_BGE_Adduct
Synonyms: Aradur 460 J90 BD, Aradur 460J90
Batch number: WA 521
Date of receipt: 24 August 2012
Storage details: stored at 15 - 25°C protected from light
Purity: 100%
Expiry date: February 2014
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- Five strains of Salmonella typhimurium bacteria (TA98, TA100, TA1535, TA1537 and TA102) were used in this study. Strains TA98, TA1535 and TA1537 were originally obtained from the UK NCTC. Strains TA100 and TA102 were derived from cultures originally obtained from Covance Laboratories Inc., USA. For all assays, bacteria were cultured at 37±1°C for 10 hours in nutrient broth, containing ampicillin (TA98, TA100) or ampicillin and tetracycline (TA102) as appropriate, to provide bacterial cultures in the range of approximately 10EO8 to 10EO9 cells/mL, based on cell count data from testing of each strain batch.
- Metabolic activation:
- with and without
- Metabolic activation system:
- The mammalian liver post-mitochondrial fraction (S-9) was prepared from male Sprague Dawley rats induced with Aroclor 1254.
- Test concentrations with justification for top dose:
- Positive controls
2-nitrofluorene: Stock concentration; 50 µg/mL, final concentration; 5 µg/mL, Strain; TA 98, without metabolic activation
Sodium azide: Stock concentration; 20 µg/mL, final concentration; 2 µg/mL, Strain; TA100 and TA1535 without metabolic activation
9-aminoacridine: Stock concentration; 500 µg/mL, final concentration; 50 µg/mL, Strain; TA1537 without metabolic activation
Mitomycin C: Stock concentration; 2 µg/mL, final concentration; 0.2 µg/mL, Strain; TA102 without metabolic activation
Benzo[a]pyrene: Stock concentration; 100 µg/mL, final concentration; 10 µg/mL, Strain; TA98 with metabolic activation
2-aminoanthracene: Stock concentration; 50 µg/mL. final concentration; 5 µg/mL, Strain; TA100, TA1535 and TA1537 with metabolic activation
2-aminoanthracene: Stock concentration; 200 µg/mL, final concentration; 20 µg/mL, Strain; TA102 with metabolic activation
Experiment 1 treatments of all the tester strains were performed in the absence and in the presence of S‑9, using final concentrations at 5, 15.81, 50, 158.1, 500, 1581 and 5000 mg/plate, plus negative (vehicle) and positive controls.
Experiment 2: treatments of all the tester strains were performed in the absence and in the presence of S-9. For strain TA98 in the absence of S-9 and strains TA100, TA1535, TA1537 and TA102 in the absence and presence of S-9, the maximum test concentration was reduced to 200 µg/plate and for strain TA98 in the presence of S-9, the maximum test concentration was reduced to 500 µg/plate based on toxicity observed in Experiment 1. Narrowed concentration intervals were employed covering the ranges 0.8192 – 200 µg/plate or 2.048 – 500 µg/plate - Vehicle / solvent:
- Dimethylformamide (DMF)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethylformamide (DMF)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-aminoanthracene
- Remarks:
- For concentrations see test concentrations section
- Details on test system and experimental conditions:
- Five strains of Salmonella typhimurium bacteria (TA98, TA100, TA1535, TA1537 and TA102) were used in this study. Strains TA98, TA1535 and TA1537 were originally obtained from the UK NCTC. Strains TA100 and TA102 were derived from cultures originally obtained from Covance Laboratories Inc., USA. For all assays, bacteria were cultured at 37±1°C for 10 hours in nutrient broth, containing ampicillin (TA98, TA100) or ampicillin and tetracycline (TA102) as appropriate, to provide bacterial cultures in the range of approximately 10EO8 to 10EO9 cells/mL, based on cell count data from testing of each strain batch. Incubation was carried out with shaking in an anhydric incubator, set to turn on using a timer switch. All treatments were completed within 6 hours of the end of the incubation period.
When the plates were set they were inverted and incubated at 37±1°C in the dark for 3 days. - Evaluation criteria:
- For valid data, the test article was considered to be mutagenic if:
1. When assessed using Dunnett's test, an increase in revertant numbers gave a significant response (p < 0.01) which was concentration related.
2. The positive trend/effects described above were reproducible.
The test article was considered positive in this assay if all of the above criteria were met.
The test article was considered negative in this assay if none of the above criteria were met.
Results which only partially satisfied the above criteria were dealt with on a case by case basis. Biological relevance was taken into account, for example consistency of response within and between concentrations and (where applicable) between experiments. - Statistics:
- Dunnett’s test used accordingly
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Following treatments of all the test strains in the absence and presence of S-9, only Experiment 2 treatments of strain TA100 in the presence of S-9 at 0.8192 µg/plate resulted in an increase in revertant numbers that was statistically significant when the data were analysed at the 1% level using Dunnett’s test. The increase was small in magnitude and occurred at a single low concentration with no indication of a concentration relationship. Accordingly this increase was considered to have been due to normal biological variability and not evidence of mutagenic activity.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
It was concluded that MonoFA_TETA_PAA_BADGE_BGE_Adduct did not induce mutation in five histidine requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium when tested under the conditions of this study. These conditions included treatments at concentrations up to toxic concentrations, in the absence and in the presence of a rat liver metabolic activation system (S-9). - Executive summary:
MonoFA_TETA_PAA_BADGE_BGE_Adduct was assayed for mutation in five histidine‑requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium, both in the absence and in the presence of metabolic activation by an Aroclor 1254‑induced rat liver post-mitochondrial fraction (S‑9), in two separate experiments.
All MonoFA_TETA_PAA_BADGE_BGE_Adduct treatments in this study were performed using formulations prepared in Dimethylformamide (DMF).
Experiment 1 treatments of all the tester strains were performed in the absence and in the presence of S‑9, using final concentrations of MonoFA_TETA_PAA_BADGE_BGE_Adduct at 5, 15.81, 50, 158.1, 500, 1581 and 5000 µg/plate, plus negative (vehicle) and positive controls. Following these treatments, evidence of toxicity was observed at 158.1 and/or 500 µg/plate and above in all strains in the absence and presence of S-9. In addition, evidence of toxicity was also observed at 50 µg/plate in strain TA102 in the absence of S-9 only.
Experiment 2 treatments of all the tester strains were performed in the absence and in the presence of S-9. For strain TA98 in the absence of S-9 and strains TA100, TA1535, TA1537 and TA102 in the absence and presence of S-9, the maximum test concentration was reduced to 200 µg/plate and for strain TA98 in the presence of S-9, the maximum test concentration was reduced to 500 µg/plate based on toxicity observed in Experiment 1. Narrowed concentration intervals were employed covering the ranges 0.8192 – 200 µg/plate or 2.048 – 500 µg/plate, in order to examine more closely those concentrations of MonoFA_TETA_PAA_BADGE_BGE_Adduct approaching the maximum test concentration and considered therefore most likely to provide evidence of any mutagenic activity. In addition, all treatments in the presence of S-9 were further modified by the inclusion of a pre-incubation step. This modification to the standard plate incorporation methodology has been known to identify mutagenic chemicals that could not be detected using the standard plate incorporation assay system. Following these treatments, evidence of was observed at 80 and/or 200 µg/plate in strain TA98 in the absence of S-9 and strains TA100, TA1535, TA1537 and TA102 in the absence and presence of S-9, and at 500 µg/plate in strain TA98 in the presence of S-9.
The test article was completely soluble in the aqueous assay system at all concentrations treated, in each of the experiments performed.
Negative (vehicle) and positive control treatments were included for all strains in both experiments. The mean numbers of revertant colonies were comparable with acceptable ranges for negative control treatments, and were significantly elevated by positive control treatments.
Although a statistically significant increase in revertant numbers was observed following MonoFA_TETA_PAA_BADGE_BGE_Adduct treatments of strain TA100 in the presence of S‑9 (Dunnett's Test, 1% level), this occurred at the lowest concentration tested, was not concentration-related or reproducible and was of insufficient magnitude to be considered as clear evidence of mutagenic activity in this assay system.
It was concluded that MonoFA_TETA_PAA_BADGE_BGE_Adduct did not induce mutation in five histidine‑requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium when tested under the conditions of this study. These conditions included treatments at concentrations up to toxic concentrations, in the absence and in the presence of a rat liver metabolic activation system (S‑9).
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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