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EC number: 947-958-4 | 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
Mutagenic based on classified constituents
Ames test positive in TA98 with metabolic activation according to OECD Guideline 471
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Classification based on calculation rules for mixtures of the CLP Regulation
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Classification based on calculation rules for mixtures of the CLP Regulation
- Key result
- Species / strain:
- other: not relevant
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- other: not relevant
- Executive summary:
The NCS is composed of several identified constituents and in that, it can be considered as a mixture according to the definition of the CLP Regulation. The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2017) was used to determine the mutagenic potential of the registered substance.
The registered substance has not been tested itself in appropriate in vitro or in vivo tests but one of its constituents is classified as mutagenic Cat. 2 (methyl eugenol) and potentially present above the CLP generic concentration limit of 1% that triggers classification of the mixture. Therefore, the registered substance is classified for mutagenicity Category 2 according to the Regulation (EC) No 1272/2008.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May- August 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine and tryptophan
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction, microsome fraction prepared from Sprague Dawley rat liver homogenate, is provided by MOLTOXTM
- Test concentrations with justification for top dose:
- Test for Mutagenicity (Experiment 1) – Plate Incorporation Method:
Salmonella strains TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2uvrA (with and without S9 mix): 10, 30, 100, 300, 500 and 1000 μg/plate
Test for Mutagenicity (Experiment 2) :
Salmonella strains TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2uvrA (with and without S9 mix): 10, 30, 100, 300, 500 and 1000 μg/plate except for TA98 with metabolica activation : 30, 100, 300, 500, 750 and 1000 µg/plate - Vehicle / solvent:
- DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- 9-aminoacridine
- sodium azide
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: cis-Platinum (II) Diammine Dichloride, 2-Nitrofluorene and 2-Anthramine
- Details on test system and experimental conditions:
- SOURCE OF TEST SYSTEM:
Strains of Salmonella typhimurium and Escherichia coli are purchased from MOLTOX
METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period:
37 °C for 30 minutes (with shaking)
- Exposure duration:
Plates were incubated at 37 °C ± 3 °C for approximately 48-72 hours
NUMBER OF REPLICATIONS:
Triplicate plates per dose level.
DETERMINATION OF CYTOTOXICITY
- Method: The plates were viewed microscopically for evidence of thinning (toxicity) - Rationale for test conditions:
- The highest dose tested was 1 000 μg / plate.
- Evaluation criteria:
- Ensure that the criteria of validity of the study are well respected namely
There should be a mimimum of four non-toxic test item dose levels
the bacteriostatic activity of the highest concentration tested shall be equal to or less than 75 %.
The spontaneous reversion rate of the absolute negative control shall comply with the historical values of the laboratory,
the spontaneous reversion rate of the solvent shall not be statistically different from absolute negative control,
the mean number of revertant colonies obtained for each strain and the corresponding positive control, with and/or without metabolic activation shall comply with the historical values of the laboratory.
Negative and positive values should not show significant difference with the historical values of the laboratory (± 2 standard deviations). - Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- STERILITY CONTROLS:
absence of any bacterial growth in the presence of the various concentrations of the test item.
absence of any bacterial growth in the presence of "S9-mix".
BACTERIOSTATIC ACTIVITY CONTROL:
Results show a high toxicity from 1500 to 5000 μg/plate. Due to the toxicity of the test item a supplementary dose was studied. The test item is tested at these doses (1 000, 500, 300, 100, 30 and 10 μg/plate).
MUTATION ASSAY
- There is no significant difference between the number of spontaneous reversions, the number of reversions obtained for the positive controls (without and with metabolic activation), and the mean of corresponding experimental historical values obtained in the laboratory.
- There is an increase in the number of revertant colonies in the presence of the test item stock solution and dilutions (750 and 500 μg/plate) with metabolic activation in Salmonella typhimurium, TA 98.
- One can observe a thinning of the bacterial lawn in the presence of the highest doses correlated with the toxicity measured.
- Results are confirmed in an independent experiment. - Conclusions:
- Doses (750 and 500 μg/plate) prepared from solutions of the test item, induce a significant increase in the number of revertants in Salmonella typhimurium, TA 98, with metabolic activation, according to the OECD Guideline n° 471.
- Executive summary:
The test item was tested for it capacity to induce reverse mutation in four Salmonella typhimurium strains and one Escherichia coli WP2(uvr A¯) (pKM101) strain. This study was performed in the absence and presence of metabolic activation. Two independent assays were carried out.
For assay n° 1, various concentrations were put in contact with the strains in the absence and presence of a metabolic activation system (S9-mix 10% (v/v)).
For assay n° 2, various concentrations were put in contact with the strains in the absence of metabolic activation and with pre-incubation in the presence of metabolic activation system (S9-mix 10% (v/v)).
For the two assays, negative and positive controls were carried out in parallel. Positive controls induced a significant increase in the number of revertant colonies compared to negative controls. There is no significant difference between the number of spontaneous reversions, the number of reversions obtained in the positive controls (without and with metabolic activation), and the mean of corresponding experimental “historical” values obtained in the laboratory.
There is an increase in the number of revertant colonies in the presence of the various concentrations of the test item (750 and 500 μg/plate), with metabolic activation in Salmonella typhimurium, TA 98.
There is no evidence of any increase in the number of revertant colonies in the presence of the various concentrations of the test item without metabolic activation in Salmonella typhimurium TA 98 as well as without and with metabolic activation in Salmonella typhimurium TA1535, TA1537, TA100 and in Escherichia coli WP2(uvrA-)(pKM101)
Doses (750 and 500 μg/plate) prepared from solutions of the test item, induce a significant increase in the number of revertants in Salmonella typhimurium, TA 98, with metabolic activation, according to the OECD Guideline n° 471.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The NCS is composed of several identified constituents and in that, it can be considered as a mixture according to the definition of the CLP Regulation. The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2017) was used to determine the mutagenic potential of the registered substance.
The registered substance has not been tested itself in appropriate in vitro or in vivo tests but one of its constituents is classified as mutagenic Cat. 2 (methyl eugenol) and potentially present above the CLP generic concentration limit of 1% that triggers classification of the mixture. Therefore, the registered substance is classified for mutagenicity Category 2 according to the Regulation (EC) No 1272/2008.
In addition in an Ames test, performed according to OECD 471 Guideline, in GLP condition the test item induce a significant increase in the number of revertants in Salmonella typhimurium, TA 98, with metabolic activation.
Justification for classification or non-classification
Harmonized classification:
The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Based on the boundary composition provided by the Lead Registrant, and the result of the OECD 471 test, the registered substance is classified for mutagenicity Category 2 (H341) according to the Regulation (EC) No. 1272/2008 (CLP).
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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