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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 Jun. - 07 Aug. 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- 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)
- Principles of method if other than guideline:
- plate incorporation assay
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of (1-phenylethyl)phenols and bis-(1-phenylethyl)phenols
- Molecular formula:
- not applicable
- IUPAC Name:
- Reaction mass of (1-phenylethyl)phenols and bis-(1-phenylethyl)phenols
- Test material form:
- liquid
- Details on test material:
- - additional information as appropriate is presented in the respective study record
1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Novares LS 500
- Source and lot/batch No.of test material: RÜTGERS Novares GmbH, batch No. 24430
- Composition of test material: composition is specified in IUCLID Sect. 13 - Assessment reports under Certificate of Analysis_Novares LS 500_phenol, styrenated
- Substance type: organic
- Purity test date: 2010/08/05
- Stability under test conditions: no measured data; based on chemical structure assumed to be stable
- Storage condition of test material: room temperature, exclusion of light
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Microsomal fraction prepared from induced livers of male Wistar rats, induced with phenobarbital (80 mg/kg bw) and ß-naphthoflavone (100 mg/kg bw) orally (3x)
- Test concentrations with justification for top dose:
- 1st experiment: 3.16, 10, 31.6, 100, 316, and 1000 µg/plate (TA 98 and TA 100, +/-S9)
1.0, 3.16, 10, 31.6, 100, and 316 µg/plate (TA 1535 and TA 1537, +/-S9)
1.0, 3.16, 10, 31.6, 100, 316, and 1000 µg/plate (TA 102, +/-S9)
2nd experiment: 15.63, 31.25, 62.5, 125, 250, and 500 µg/plate (TA 98 and TA 100, +/-S9)
3.91, 7.81, 15.63, 31.25, 62.5, 125, and 250 µg/plate (TA 1535 and TA 1537, +/-S9)
7.81, 15.63, 31.25, 62.5, 125, 250, and 500 µg/plate (TA 102, +/-S9) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: compatible with survival of bacteria and S9 activity
Controls
- Untreated negative controls:
- yes
- Remarks:
- dist. water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylenediamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (1st and 2nd experiment: plate incorporation test)
NUMBER OF REPLICATIONS: 3 per concentration
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth/colony formation
- Evaluation criteria:
- Considered as mutagenic
- if a clear and dose-related increase in the number of revertants occurs in at least one tester with or without metabolic activation
and/or
- if a biologically relevant positive response for at least one of the dose groups occurs in at least one tester with or without metabolic activation.
An increase is considered relevant
- if in TA 100 and TA 102 mutation rate is at least twice as high as the rate of the solvent control;
- if in TA 98, TA 1535, and TA 1537 the mutation rate is at least 3x higher than that of the solvent control.
- Statistics:
- According to the OECD guidelines, the biological relevance is the criterion for the interpretation of the results: a statistical evaluation was not considered necessary under this premise (report p. 21).
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- reproducible in both tests
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- reproducible, >=31 µg/pl. (-S9); >= 125 µg/pl. (+S9), depending on tester strain
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- reproducible in both tests
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- reproducible, >=31 µg/pl. (-S9); >= 125 µg/pl. (+S9), depending on tester strain
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- reproducible in both tests
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- reproducible, >=31 µg/pl. (-S9); >= 125 µg/pl. (+S9), depending on tester strain
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- reproducible in both tests
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- reproducible, >=31 µg/pl. (-S9); >= 125 µg/pl. (+S9), depending on tester strain
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- Remarks:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- reproducible: >=31 µg/pl. (-S9); >= 125 µg/pl. (+S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
Any other information on results incl. tables
Summary:
No biologically relevant increases in revertant colony numbers were observed in the four tester strains, TA 1535, TA 1537, TA 98 and TA 102, following treatment with Novares LS 500, either in the presence or in the absence of metabolic activation.
Biologically relevant, dose-related increases were found in tester strain TA 100 at 100 µg/pl. without S9 and at 316 µg/pl. under metabolic activation (1st exp.) and at 62.5 and 125 µg/pl. without S9 and at 250 µg/pl. with S9 (2nd exp.): a maximum mutation factor of 3 was reached in the presence of S9. The mutagenic doses in the absence or presence of metabolic activation were cytotoxic as well.
All reference mutagens induced distinct increases of revertant colonies indicating the validity of the experiment.
Applicant's summary and conclusion
- Conclusions:
- The test substance is not considered to be positive in the Ames test as tester strains TA 98, TA 102, TA 1535, and TA 1537 did not show any cytotoxic effects with and without metabolic activation even at cytotoxic concentrations. Only strain TA 100 responded slightly positve at cytotoxic concentrations without clear dose-response relationship.
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.