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EC number: 950-156-7 | 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
The substance consists of three structurally similar bisamides: N,N'-ethane-1,2-diylbis(12-hydroxyoctadecanamide), N,N'-hexane-1,6-diylbis(12-hydroxyoctadecanamide) and N,N'-[1,3-phenylenebis(methylene)]bis(12-hydroxyoctadecanamide). Experimental data on this substance are not available. The individual constituents and mixtures of them and similar amides are considered suitable read-across substances. In guideline studies on two read-across substances, 12-hydroxyoctadecanoic acid, reaction products with 1,3-benzenedimethanamine and hexamethylenediamine and 1,3-bis[12-hydroxy-octadecamide-N-methylene]-benzene, no mutagenicity was observed in Bacterial Reverse Mutation Assays as well as in chromosome aberration studies. The Bacterial Reverse Mutation Assay of another read-across substance, N,N'-ethane-1,2-diylbis(12-hydroxyoctadecanamide), was also negative. Due to the high structural similarity of the three-constituent substance to these read-across substances the genetic toxicity is expected to be comparable.
Based on the experimental data on read-across substances, the substance does not need to be classified for genetic toxicity according to CLP criteria. Additional testing of the substance is not considered necessary, in vitro as well as in vivo.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 . Dec. 2018 - 11 Apr. 2019
- 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
- Species / strain / cell type:
- other: Salmonella typhimurium LT2 Strains TA97a, TA98, TA100, TA102 and TA1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix
- Test concentrations with justification for top dose:
- Exp. I: 50, 150, 500, 1500 and 5000 μg/plate (with and without metabolic activation)
Exp. II: 156, 313, 625, 1250, 2500 and 5000 μg/plate (with and without metabolic activation) - Vehicle / solvent:
- In a non-GLP pre-test, the solubility of the test item was tested in a concentration of 50 g/L in demineralized water, dimethyl sulfoxide (DMSO), tetrahydrofuran and acetone. The test item is not sufficiently soluble in all solvents. Based on the non-GLP pre-test, acetone was chosen as vehicle, because it showed the best suspension and this solvent does not have any effects on the viability of the bacteria or the number of spontaneous revertants in the tested concentrations.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 4-Nitro-1,2-phenylene diamine; CAS-No.: 99-56-9
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation
- Evaluation criteria:
- The colonies were counted visually and the numbers were recorded. A validated spreadsheet software (Microsoft Excel®) was used to calculate mean values and standard deviations of each treatment, solvent control and positive control. The mean values and standard deviations of each threefold determination was calculated as well as the increase factor f(l) of revertant induction (mean revertants divided by mean spontaneous revertants) of the test item solutions and the positive controls. Additionally, the absolute number of revertants (Rev. Abs.) (mean revertants less mean spontaneous revertants) was given. A substance is considered to have mutagenic potential, if a reproducible increase of revertant colonies per plate exceeding an increase factor of 2 in at least one strain can be observed. A concentration-related increase over the range tested is also taken as a sign of mutagenic activity.
- Key result
- Species / strain:
- other: Salmonella typhimurium LT2 Strains TA97a, TA98, TA100, TA102 and TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- All validity criteria are fulfilled. The study can be considered valid. Based on the results of this study it is concluded that Bisamid is not mutagenic in the Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in this study.
- Executive summary:
Three valid experiments were performed. The study procedures described in this report were based on the most recent OECD and EC guidelines. The test item Bisamid was tested in the Salmonella typhimurium reverse mutation assay with five strains of Salmonella typhimurium (TA97a, TA98, TA100, TA102 and TA1535). The test was performed in three experiments in the presence and absence of metabolic activation, with +S9 standing for presence of metabolic activation, and –S9 standing for absence of metabolic activation. Experiment 1a: In the experiment 1a, the test item (suspended in acetone) was tested up to concentrations of 5000 μg/plate in the absence and presence of S9-mix in the strains TA97a, TA98, TA100, TA102 and TA1535 using the plate incorporation method. The test item showed no precipitates on the plates at any of the concentrations. The bacterial background lawn was not reduced at any of the concentrations and no relevant decrease in the number of revertants was observed in all bacteria strains. The test item showed no signs of toxicity towards the bacteria strains in both the absence and presence of metabolic activation. The results of this experiment showed that none of the tested concentrations showed a significant increase in the number of revertants in all tested strains, in the presence and the absence of metabolic activation. Due to contamination of bacteria strain TA97a, the evaluation of the bacteria strain TA97a was not possible, therefore a repetition of the experiment for this bacteria strain was performed (Experiment 1b). Experiment 1b: Based on the contamination of the bacteria strain TA97a in experiment 1a, the experiment was repeated under the same conditions with this bacteria strain. The test item (suspended in acetone) was tested up to concentrations of 5000 μg/plate in the absence and presence of S9-mix for the bacteria strain TA97a. The test item showed no precipitates on the plates at any of the concentrations. The bacterial background lawn was not reduced at any of the concentrations and no relevant decrease in the number of revertants was observed in all bacteria strains. The test item showed no signs of toxicity towards the bacteria strains in both the absence and presence of metabolic activation. The results of this experiment showed that none of the tested concentrations showed an increase in the number of revertants in the tested strain, in the presence and the absence of metabolic activation.
Experiment 2: Based on the first experiments, the test item was tested up to concentrations of 5000 μg/plate in the absence and presence of S9-mix in all bacteria strains using the pre-incubation method. The test item showed no precipitates on the plates at any of the concentrations. The bacterial background lawn was not reduced at any of the concentrations and no relevant decrease in the number of revertants was observed in all bacteria strains. The test item showed no signs of toxicity towards the bacteria strains in both the absence and presence of metabolic activation. The results of this experiments showed that the test item caused no increase in the number of revertants in all bacteria strains compared to the solvent control, in both the absence and presence of metabolic activation. The test item did not induce a dose-related increase in the number of revertant colonies in all strains, in the presence and absence of metabolic activation.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- EEC Directive 92/69, B14
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver S9-homogenate
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 3 ... 333 μg/plate
Concentration range in the main test (without metabolic activation): 3 ... 333 μg/plate
Concentration of 333 μg/plate of the test substance results in precipitation. - Vehicle / solvent:
- Solvent: DMSO
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 333 μg/plate
- Species / strain:
- bacteria, other: TA1537, TA1535, TA98, TA100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 µg/plate
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- bacteria, other: TA1537, TA1535, TA98, TA100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 µg/plate
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- bacteria, other: TA1537, TA1535, TA98, TA100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 333 μg/plate
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- bacteria, other: TA1537, TA1535, TA98, TA100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 333 μg/plate
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- Observations: None.
- Remarks on result:
- other: preliminary test
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation - Executive summary:
The genetic toxicity of 1,3-bis[12-hydroxy-octadecamide-N-methylene]-benzene is assessed in a guideline study (bacterial reverse mutation assay, Ames test) according to EU Method B.14. Under the conditions of the test, no genetic toxicity is observed on Salmonella typhimurium strains TA 100, TA 1535, TA 1537 and TA 98 in the presence or absence of metabolic activation using Aroclor 1254-induced rats liver S9 homogenates. Therefore, we conclude that the test substance has no mutagenic effects.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- EEC Directive 92/69 B.10
- GLP compliance:
- yes
- Type of assay:
- other: in vitro mammalian cytogenicity (B10)
- Species / strain / cell type:
- lymphocytes: Peripheral human lymphocytes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver S9-homogenate.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 1 ... 10 μg/ml
Concentration range in the main test (without metabolic activation): 1 ... 10 μg/ml
At a concentration of 10 μg/ml the test substance precipitated in the culture medium. Therefore, a concentration of 10 μg/ml was used as the highest concentration. - Vehicle / solvent:
- DMSO
- Details on test system and experimental conditions:
- Exposure period (with metabolic activation): 3 h
Exposure period (without metabolic activation): 24 h
Expression time:
With S9 mix 3 h treatment
Without S9 mix 24 and 48 h treatment
Fixation time:
With S9 mix treatment cells were incubated for another 20-22 h (24 h fixation) or 44-46 h (48 h fixation).
Cells treated without S9 were worked up immediately after treatment (24h and 48h fixation time). - Species / strain:
- lymphocytes: Peripheral human lymphocytes
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 10 μg/ml
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- lymphocytes: Peripheral human lymphocytes
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 10 μg/ml
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: preliminary test
- Conclusions:
- Interpretation of results:
negative with metabolic activation
negative without metabolic activation - Executive summary:
The genetic toxicity of 1,3-bis[12-hydroxy-octadecamide-N-methylene]-benzene is assessed in a guideline study (chromosome aberration study in mammalian cells) according to EU Method B.10. Under the conditions of the test, no genetic toxicity is observed on peripheral human lymphocytes in the presence or absence of metabolic activation using Aroclor 1254-induced rats liver S9 homogenates. Therefore, we conclude that the test substance has no mutagenic effects.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (Ames test)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Remarks:
- strain CM891
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S-9
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 5 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 5 ... 5000 μg/plate - Vehicle / solvent:
- Solvent: Purified water with 0.15% agar to assist suspension
- Species / strain:
- bacteria, other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- bacteria, other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- Observations: No signs of toxicity were observed towards the tester strains in either mutation test.
- Remarks on result:
- other: main test
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation - Executive summary:
The genetic toxicity of 12-hydroxyoctadecanoic acid, reaction products with 1,3-benzenedimethanamine and hexamethylenediamine is assessed in a guideline study (bacterial reverse mutation assay, Ames test) according to Annex V. Under the conditions of the test, the test substance does not exhibit genetic toxicity on Salmonella typhimurium strains TA 100, TA 1535, TA 1537, TA 98 and Escherichia coli strain CM891 in the presence or absence of metabolic activation using Aroclor 1254-induced rats liver S9 homogenates. Therefore, we conclude that the test substance has no mutagenic effects.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (In vitro cytogenetics)
- GLP compliance:
- yes
- Type of assay:
- other: in vitro mammalian cytogenicity (B10)
- Species / strain / cell type:
- mammalian cell line, other: Human lymphocytes in whole blood culture
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S9
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 1250 ... 5000 μg/ml
Concentration range in the main test (with metabolic activation): 2500 ... 5000 μg/ml
Concentration range in the main test (without metabolic activation): 1250 ... 5000 μg/ml
Concentration range in the main test (without metabolic activation): 625 ... 2000 μg/ml - Vehicle / solvent:
- Culture medium
- Details on test system and experimental conditions:
- Exposure period (with metabolic activation): 3 hours
Exposure period (without metabolic activation): 3 hours
Fixation time:
All cultures were harvested after 20 hours. - Species / strain:
- mammalian cell line, other: Human lymphocytes in whole blood culture
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 μg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- mammalian cell line, other: Human lymphocytes in whole blood culture
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 2000 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Observations:
In both the absence and presence of S-9 mix, the test substance caused no statistically significant increase in the proportion of metaphase figures containing chromosomal aberrations, at any dose level, when compared with the solvent control, in either test. Positive and negative controls produced appropriate results. - Remarks on result:
- other: main test
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation - Executive summary:
The genetic toxicity of 12-hydroxyoctadecanoic acid, reaction products with 1,3-benzenedimethanamine and hexamethylenediamine is assessed in a guideline study (chromosome aberration study in mammalian cells) according to EU Method B.10. In the presence of metabolic activation (Aroclor 1254 -induced rats liver S9), the test substance does not exhibit genetic toxicity on human lymphocytes in whole blood culture up to 5000 µg/mL. In the absence of metabolic activation, no genetic toxicity is observed for a test substance concentration of up to 2000 µg/mL. Therefore, we conclude that the test substance has no mutagenic effects.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
There are no in vivo genetic toxicity data on the substance and suitable read-across substances available. Nevertheless, the available information from in vitro studies is considered sufficient for assessment. Therefore, testing of the genetic toxicity of the substance in vivo is not necessary.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Predictions of the genetic toxicity of the three individual constituents by the (Q)SAR software tool ChemProp 6.7 were disregarded because the three constituents were outside of the applicability domain of the used models.
Justification for classification or non-classification
Based on the experimental data on read-across substances, the substance does not need to be classified for genetic toxicity according to CLP criteria. Additional testing of the substance is not considered necessary, in vitro as well as in vivo.
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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