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Diss Factsheets
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EC number: 239-816-9 | CAS number: 15721-78-5
- 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 21 September 2012 to 22 January 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with validated testing guidelines and under GLP conditions.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Experiment 1: 15.63, 31.25, 62.5, 125, 250, 500 μg/mL
Experiment 2: 15.63, 31.25, 62.5, 125, 250, 500 μg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
No additional data - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- Experiment 1 (-S9) 4-Hour Exposure; Experiment 2 (-S9) 24-Hour Exposure
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- Experiment 1 (+S9) 4-Hour Exposure
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: In Experiment 1, 4-hour exposure; In Experiment 2, 4-hour exposure and 24-hour exposure
NUMBER OF REPLICATIONS: 2
OTHER EXAMINATIONS:
- Other: The daily cell counts were used to obtain a Relative Suspension Growth (%RSG) value that gives an indication of post treatment toxicity during the expression period as a comparison to the vehicle control, and when combined with the Viability (%V) data a Relative Total Growth (RTG) value.
No additional data - Evaluation criteria:
- Vehicle controls results should ideally be within this range, although minor errors in cell counting and dilution or exposure to the metabolic activation system may cause this to be slightly elevated. Experiments where the vehicle control values are markedly greater than 2E-04 mutant frequency per survivor are
not normally acceptable and will be repeated.
Positive control chemicals should induce at least three to five fold increases in mutant frequency greater than the corresponding vehicle control. - Statistics:
- None stated
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Additional information on results:
- With no evidence of significant toxicity in the preliminary toxicity test, the maximum dose level used in the Mutagenicity Test was limited by the onset of greasy/oily precipitate that was considered to be effectively reducing exposure of Bis(4‐(1,1,3,3‐tetramethylbutyl)phenyl)amine to the cells.
In the Mutagenicity Test, precipitate of Bis(4‐(1,1,3,3‐tetramethylbutyl)phenyl)amine was observed at and above 31.25 μg/mL and became greasy/oily in appearance at 500 μg/mL. The vehicle (solvent) controls had mutant frequency values that were considered acceptable for the L5178Y cell line at the TK +/- locus.
The positive control items induced marked increases in the mutant frequency indicating the satisfactory performance of the test and of the activity of the metabolising system. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Bis(4‐(1,1,3,3‐tetramethylbutyl)phenyl)amine did not induce any toxicologically significant increases in the mutant frequency at the TK +/- locus in L5178Y cells and is therefore considered to be non-mutagenic under the conditions of the test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Ames
Key study:
According to an OECD 471 conducted according to GLP, Bis(4-(1,1,3,3-tetramewthylbutyl)phenyl)amine is negative in S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 (with and without activation). Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is considered to be non-mutagenic to bacteria under the conditions of this test (Harlan Laboratories Ltd, 2012).
Chromosome aberration
Key Study:
According to an OECD 476, conducted according to GLP, Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is negative in human lymphocytes. Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is considered to be non-clastogenic and non-aneugenic to human lymphocytesin vitro (Harlan Laboratories Ltd, 2013).
Mammilian gene mutation
According to an OECD 476, conducted according to GLP, Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is negative using mouse lymphoma L5178Y cells. Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is not mutagenic in the mouse lymphoma L5178Y test system under the experimental conditions (Harlan Laboratories Ltd., 2013).
Justification for selection of genetic toxicity endpoint
The study was conducted according to appropriate OECD Guidelines (OECD 487), under GLP conditions at a reputable European Union laboratory.
The study in mammalian cells was chosen over that in bacterial cells, as the higher level study.
Justification for classification or non-classification
Bis(4 -(1,1,3,3 -tetramethylbutyl)phenyl)amine is negative in S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 (with and without activation), negative in human lymphocytes and negative using mouse lymphoma L5178Y cells.
Based upon Table 3.5.1 of Regulation EC No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is not classified for genotoxicity.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.