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EC number: 272-034-6 | CAS number: 68649-66-1
- 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
Ames-Test:
The test item didn't show mutagenic effects in both experiments. The number of revertant colonies was not increased in comparison with the spontaneous revertants (solvent only). Cytotoxicity of the test item was not detected. The background lawn was visible and the number of revertants was not significantly decreased. Therefore it can be stated, that under the test conditions, the test item MELON 1,3,5-Triazine-2,4,6-triamine, deammonated is not mutagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium, strains TA 97a, TA 98, TA 100, TA 102 and TA 1535.
In vitro micronucleus test/mouse lymphoma assay:
According to section 1 of REACH Regulation (EC) Annex XI, testing for genetic toxicity does not need to be conducted if testing does not appear scientifically necessary. For genetic toxicity 1,3,5-Triazine-2,4,6-triamine, deammoniated will have to be made bioavailable to the target gene in sufficient concentration to cause the mutagenic effect. This requires that the polymer molecules will have to be bioavailable by absorption via relevant routes of exposure. It is therefore unlikely to occur with this insoluble substance . Since the gut wall presents a substantial barrier to prevent uptake of high molecular weight substances, 1,3,5-Triazine-2,4,6-triamine, deammoniated is unlikly to cross the gastro-intestinal epithelium and to become systemically available for distribution to internal target tissues and organs. Considering the above mentioned factors, 1,3,5-Triazine-2,4,6-triamine, deammoniated is obviously devoid of toxicity via the oral route, i.e. (in vivo) genetic toxicity is no relevant toxicological endpoint. This applies also for any dermal exposure because permeation of a chemical through the Stratum corneum is basically a diffusion process in which active transport plays no role. The layer with the highest resistance to diffusion is the rate-limiting membrane. For many compounds,the lipophilic Stratum corneum is the primary or rate-limiting barrier. According to the so-called “Dalton rule” the molecular weight of a molecule may not exceed 500 Dalton (500 g/Mol) for a quantitative relevant skin penetration. The molecular weight of 1,3,5-Triazine-2,4,6-triamine, deammoniated is expected to be higher than 500 g/Mol (see mass spectrum and HPLC-analysis). In addition 1,3,5-Triazine-2,4,6-triamine, deammoniated is insoluble in water and not fat soluble, consequently it is not expected to be absorbed through the skin. Taking this into account, dermal absorption of 1,3,5-Triazine-2,4,6-triamine, deammoniated is not expected. The other appropriate route of exposure to 1,3,5-Triazine-2,4,6-triamine, deammoniated is the inhalative one which is also of no relevance due to the bio-inertness of the substance. The executed bacterial reverse mutation assay in bacteria with 1,3,5-Triazine-2,4,6-triamine, deammoniated supports the above outlined rationale that this insoluble and bio-inert substance is devoid of any mutagenic properties.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The GLP study was conducted according to an internationally accepted guideline (OECD 471). All study parameters are based on the specific guideline.
- 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: TA97a, TA98, TA100, TA102, TA1535
- Details on mammalian cell type (if applicable):
- Mutations:
TA97a: hisD6610, uvrB, pKM 101, rfa
TA 98: hisD3052, uvrB, pKM 101, rfa
TA 100 : hisG46, uvrB, pKM 101, rfa
TA102: hisG428, pKM 101, rfa
TA1535: hisG46, uvrB, rfa. - Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- Plate incorporation method: 5005 / 1502 / 515 /148 / 54 µg/plate
- Vehicle / solvent:
- The test item was suspended in sterile H2O demin.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-1,2-phenylene diamine
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-Amino-anthracene
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Evaluation criteria:
- A test item is considered to have mutagenic potential, if a significant, reproducible increase of revertant colonies per plate (increase factor > 2) in at least one strain can be observed. A concentration-related increase over the range tested can also be taken as a sign of mutagenic activity.
- Species / strain:
- other: TA97a, TA98, TA100, TA102, 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
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item MELON 1,3,5- Triazine-2,4,6-triamine, deammonated is not mutagenic under the conditions of the test. - Executive summary:
The test item didn't show mutagenic effects in both experiments. The number of revertant colonies was not increased in comparison with the spontaneous revertants (solvent only). Cytotoxicity of the test item was not detected. The background lawn was visible and the number of revertants was not significantly decreased. Therefore it can be stated, that under the test conditions, the test item MELON 1,3,5-Triazine-2,4,6-triamine, deammonated is not mutagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium, strains TA 97a, TA 98, TA 100, TA 102 and TA 1535.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Additional information from genetic toxicity in vitro:
Justification for selection of genetic toxicity endpoint
Only one in vitro study available, further testing waived, see respective endpoint study records
Justification for classification or non-classification
The bioavailability of the registered substance is -based on scientific reasoning- negligible. From this follows, that a relevant genetic toxicity is not likely and not expected.
Therefore the substance has not to be classified for germ cell mutagenicity.
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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