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EC number: 947-785-4 | 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
The test substance fatty acid, tall oil, reaction products with diethylenetriamine, maleic acid, tetraetyhlenpentamine and triethylenetetramine was assessed in three in vitro mutagenicity studies, namely according to OECD 471, 473 and 476, and was found negative in all three studies for mutagenicity. The results on the source substance can be used to assess the mutagenic potential of the target substance fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine, which is a main component of the source substance, and thus, also the target substance can be considered negative for mutagenicity.
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:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The target substance Fatty acids, tall-oil, reaction products with maleic anhydride and triethylene-tetramine (TOFA-MA-TETA) and the source substance Fatty acids, tall-oil, reaction products with di-ethylenetriamine (DETA), maleic anhydride, tetraethylenepentamine (TEPA) and triethylenetetramine (TETA) are characterised by the same starting materials: the hydrophobic part from fatty acids and the hydrophilic part from the polyethyleneamines.
The source substance is a mixture of ethyleneamines of different lengths (DETA, TETA and TEPA). The target substance contains only one ethyleneamine: TETA.
The source and the target substance show therefore the same reactive groups and a similar composition with the absence of two original ethyleneamines (DETA and TEPA) as biggest difference. A read-across to the source is therefore justified.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The target substance actually is manufactured from the same starting materials of the source:
Fatty acids, tall-oil and maleic anhydride. TOFA is reacted with maleic anhydride to make a Diels-Alder intermediate which is a tri-acid. This is reacted with the TETA to produce a mixture of amido-amine & oligomeric UVCB constituents. The source substance also contains two other ethyleneamines: di-ethylenetriamine and tetraethylenepentamine.
The source substance has been registered already and was found not being genotoxic in a bacterial genetic toxicity test in vitro. The same conclusion is applied to the target substance.
3. ANALOGUE APPROACH JUSTIFICATION
The target substance is one of the constituent of the UVCB source substance and thus read-across from the bigger compound Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine to TOFA-MA-TETA is common practice and justified.
4. DATA MATRIX
Whereas the source substance is a Fatty acids, tall-oil, reaction products with di-ethylenetriamine (DETA), maleic anhydride, tetraethylenepentamine (TEPA) and triethylenetetramine (TETA), hence using a mixture of DETA, TETA and TEPA as reactant, the target substance uses pure TETA (triethylenetetramine) instead, being a more purified (narrower cut distillation) form of DETA/TETA/TEPA resulting in a name change of the target substance, being Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine (TETA). - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at >3 mg/plate in absence of S9 and at 5 mg/plate in presence of S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- 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
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at >3 mg/plate in absence of S9 and at 1 mg/plate in presence of S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5 mg/plate in the initial assay and at 3 mg/plate in the repeat assay, in absence of S9. At > 3 mg/plate in presence of S9.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- 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:
- There was no evidence of an increase in the number of revertant colonies that exceeded twice background in any of the five tester strains examined at dose levels up to 5 mg/plate in the presence or absence of a metabolic activation source (S9). The lack of a mutagenic response indicates that the source substance fatty acid, tall oil, reaction products with diethylenetriamine, maleic anhydride, tetraetyhlenpentamine and triethylenetetramine as well as the target substance fatty acid, tall oil, reaction products with maleic anhydride and triethylenetetramine is non genotoxic in tester strains TA97a, TA98, TA100, TA102 and TA1535 under the conditions employed. Based on these results, Polyamide is not likely to be carcinogenic.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The target substance Fatty acids, tall-oil, reaction products with maleic anhydride and triethylene-tetramine (TOFA-MA-TETA) and the source substance Fatty acids, tall-oil, reaction products with di-ethylenetriamine (DETA), maleic anhydride, tetraethylenepentamine (TEPA) and triethylenetetramine (TETA) are characterised by the same starting materials: the hydrophobic part from fatty acids and the hydrophilic part from the polyethyleneamines.
The source substance is a mixture of ethyleneamines of different lengths (DETA, TETA and TEPA). The target substance contains only one ethyleneamine: TETA.
The source and the target substance show therefore the same reactive groups and a similar composition with the absence of two original ethyleneamines (DETA and TEPA) as biggest difference. A read-across to the source is therefore justified.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The target substance actually is manufactured from the same starting materials of the source:
Fatty acids, tall-oil and maleic anhydride. TOFA is reacted with maleic anhydride to make a Diels-Alder intermediate which is a tri-acid. This is reacted with the TETA to produce a mixture of amido-amine & oligomeric UVCB constituents. The source substance also contains two other ethyleneamines: di-ethylenetriamine and tetraethylenepentamine.
The source substance has been registered already and considered to be non-clastogenic in a chromosome aberration test. The same conclusion is applied to the target substance.
3. ANALOGUE APPROACH JUSTIFICATION
The target substance is one of the constituent of the UVCB source substance and thus read-across from the bigger compound Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine to TOFA-MA-TETA is common practice and justified.
4. DATA MATRIX
Whereas the source substance is a Fatty acids, tall-oil, reaction products with di-ethylenetriamine (DETA), maleic anhydride, tetraethylenepentamine (TEPA) and triethylenetetramine (TETA), hence using a mixture of DETA, TETA and TEPA as reactant, the target substance uses pure TETA (triethylenetetramine) instead, being a more purified (narrower cut distillation) form of DETA/TETA/TEPA resulting in a name change of the target substance, being Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine (TETA). - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5375 - In vitro Mammalian Chromosome Aberration Test
- GLP compliance:
- yes (incl. QA statement)
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 1 mg/mL in experiment II without S9, a relevant decrease of the relative mitotic index (<70%) was noted
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- The test item fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine, the source substance, is considered to be non-clastogenic and as this is also considered for the target substance fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The target substance Fatty acids, tall-oil, reaction products with maleic anhydride and triethylene-tetramine (TOFA-MA-TETA) and the source substance Fatty acids, tall-oil, reaction products with di-ethylenetriamine (DETA), maleic anhydride, tetraethylenepentamine (TEPA) and triethylenetetramine (TETA) are characterised by the same starting materials: the hydrophobic part from fatty acids and the hydrophilic part from the polyethyleneamines.
The source substance is a mixture of ethyleneamines of different lengths (DETA, TETA and TEPA). The target substance contains only one ethyleneamine: TETA.
The source and the target substance show therefore the same reactive groups and a similar composition with the absence of two original ethyleneamines (DETA and TEPA) as biggest difference. A read-across to the source is therefore justified.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The target substance actually is manufactured from the same starting materials of the source:
Fatty acids, tall-oil and maleic anhydride. TOFA is reacted with maleic anhydride to make a Diels-Alder intermediate which is a tri-acid. This is reacted with the TETA to produce a mixture of amido-amine & oligomeric UVCB constituents. The source substance also contains two other ethyleneamines: di-ethylenetriamine and tetraethylenepentamine.
The source substance has been registered already and it has been considered to be non mutagenic in the mouse lymphoma thymidine kinase locus using the cell line L5178Y. The same conclusion is applied to the target substance.
3. ANALOGUE APPROACH JUSTIFICATION
The target substance is one of the constituent of the UVCB source substance and thus read-across from the bigger compound Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine to TOFA-MA-TETA is common practice and justified.
4. DATA MATRIX
Whereas the source substance is a Fatty acids, tall-oil, reaction products with di-ethylenetriamine (DETA), maleic anhydride, tetraethylenepentamine (TEPA) and triethylenetetramine (TETA), hence using a mixture of DETA, TETA and TEPA as reactant, the target substance uses pure TETA (triethylenetetramine) instead, being a more purified (narrower cut distillation) form of DETA/TETA/TEPA resulting in a name change of the target substance, being Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine (TETA). - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Growth inhibition was observed in exp I and II with and without metabolic activation.
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Conclusions:
- The test substance fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine is considered to be non mutagenic in the mouse lymphoma thymidine kinase locus using the cell line L5178Y, and likewise the same is assumed for fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine (the target substance).
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Based on three negative in vitro mutagenicity studies, the substance is considered non-mutagenic and thus, no classification for mutagenic potential according to CLP (Regulation EC No 1272/2008) is required.
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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