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EC number: 268-048-7 | CAS number: 67990-27-6
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Gene mutation in vitro:
Ames test:
The test chemical 2,2'-[(3,3'-dimethyl [1,1'-biphenyl]-4,4'-diyl)bis (azo)] bis[4-nonylphenol] (CAS no 67990 -27 -6) is not mutagenic to the Salmonella typhimurium strains in the presence and absence of liver S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- experimental data of read across substances
- Justification for type of information:
- Data for the target chemical is summarized based on the structurally similar read across chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- WoE derived based on the experimental data from structurally and functionally similar read across chemicals
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium, other: TA98 and TA100
- Remarks:
- 1
- Details on mammalian cell type (if applicable):
- No data
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium, other: TA100, TA98, TA1535, TA1537 and TA1538
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 was prepared from Aroclor-induced male Fischer F344 rats
- Test concentrations with justification for top dose:
- 1. 0, 222, 444, 888, 1776 or 3552 µg/plate
2. 200 µg/Plate - Vehicle / solvent:
- 1./2. - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test chemical is soluble in DMSO - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- 1
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- ethylmethanesulphonate
- methylmethanesulfonate
- other: Anthragallol, 2-Anthramine
- Details on test system and experimental conditions:
- 1. METHOD OF APPLICATION: Liquid preincubation
DURATION
- Preincubation period: 30 mins in gyratory water bath
- Exposure duration: No data
- Expression time (cells in growth medium): No data
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available
SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available
NUMBER OF REPLICATIONS: Triplicate
NUMBER OF CELLS EVALUATED: No data available
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available
OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: No data available
OTHER: No data available
2. METHOD OF APPLICATION: Spot test
DURATION
- Preincubation period: No data
- Exposure duration: 72 hrs
- Expression time (cells in growth medium): 72 hrs
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data
NUMBER OF REPLICATIONS: No data
NUMBER OF CELLS EVALUATED: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data
OTHER: No data - Rationale for test conditions:
- No data
- Evaluation criteria:
- 1. The plates were observed for increase in the number of revertants/plate
2. The criteria adopted for scoring a mutagenic response in routine plate tests was that the observed number of revertants should exceed twice the background value for that given assay and exceed the 99.9% confidence limit based on our historical controls. - Statistics:
- 1. Mean ± SD
2. No data - Species / strain:
- S. typhimurium, other: TA98 and TA100
- Remarks:
- 1
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA100, TA98, TA1535, TA1537 and TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- 1/2.. No data
- Remarks on result:
- other: No mutagenic potential
- Conclusions:
- The test chemical 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol] is not mutagenic to the Salmonella typhimurium strains in the presence and absence of liver S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
- Executive summary:
Data available for the test chemical was reviewed to determine its mutagenic nature of 2,2'-[(3,3'-dimethyl [1,1'-biphenyl]-4,4'-diyl)bis (azo)] bis[4-nonylphenol]. The studies are as mentioned below:
The test chemical was studied for its ability to induce mutations in strains of Salmonella typhimurium TA98 and TA100. The test compound was dissolved in DMSO and was tested at concentration of 0, 222, 444, 888, 1776 or 3552 µg/plate using Salmonella typhimurium TA100 and TA98 in the presence and absence of liver S9 metabolic activation system. Liquid preincubation assay was performed with a preicubation for 30 mins. The plates were observed for histidine independence. Concurrent solvent and positive controls were included in the study. The test chemical is not mutagenic to the Salmonella typhimurium TA100 and TA98 in the presence and absence of liver S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
In another study, Gene mutation by the spot assay was performed for the test chemical. The given chemical was used at dose level of 200 µg/plate both with and without S9 metabolic activation system. The plates were incubated for 3 days at 37°C for the growth of colonies to occur. The plates were observed for an increase in the number of His+ revertants. The criteria adopted for scoring a mutagenic response in routine plate tests was that the observed number of revertants should exceed twice the background value for that given assay and exceed the 99.9% confidence limit based on our historical controls. Concurrent positive control was also included in the study. The test chemical did not induce mutation in Salmonella typhimurium strain TA100, TA98, TA1535, TA1537 and TA1538 with and without S9 metabolic activation system in the spot test performed and hence is not likely to classify for gene mutation in vitro.
Based on the data available for the test chemical, 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol] is not mutagenic to the Salmonella typhimurium strains in the presence and absence of liver S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Gene mutation in vitro:
Data available for the test chemical was reviewed to determine its mutagenic nature of 2,2'-[(3,3'-dimethyl [1,1'-biphenyl]-4,4'-diyl)bis (azo)] bis[4-nonylphenol] (CAS no 67990 -27 -6). The studies are as mentioned below:
The test chemical was studied for its ability to induce mutations in strains of Salmonella typhimurium TA98 and TA100. The test compound was dissolved in DMSO and was tested at concentration of 0, 222, 444, 888, 1776 or 3552 µg/plate using Salmonella typhimurium TA100 and TA98 in the presence and absence of liver S9 metabolic activation system. Liquid preincubation assay was performed with a preicubation for 30 mins. The plates were observed for histidine independence. Concurrent solvent and positive controls were included in the study. The test chemical is not mutagenic to the Salmonella typhimurium TA100 and TA98 in the presence and absence of liver S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
In another study, Gene mutation by the spot assay was performed for the test chemical. The given chemical was used at dose level of 200 µg/plate both with and without S9 metabolic activation system. The plates were incubated for 3 days at 37°C for the growth of colonies to occur. The plates were observed for an increase in the number of His+ revertants. The criteria adopted for scoring a mutagenic response in routine plate tests was that the observed number of revertants should exceed twice the background value for that given assay and exceed the 99.9% confidence limit based on our historical controls. Concurrent positive control was also included in the study. The test chemical did not induce mutation in Salmonella typhimurium strain TA100, TA98, TA1535, TA1537 and TA1538 with and without S9 metabolic activation system in the spot test performed and hence is not likely to classify for gene mutation in vitro.
Based on the data avalable for the test chemical, 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol] (CAS no 67990 -27 -6) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to be mutagenic as per the criteria mentioned in CLP regulation.
Justification for classification or non-classification
Based on the data avalable for the test chemical, 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol] (CAS no 67990 -27 -6) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to be mutagenic as per the criteria mentioned in CLP regulation.
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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