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EC number: 240-004-1 | CAS number: 15875-13-5
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan 23 to 29, 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N,N,N',N',N'',N''-hexamethyl-1,3,5-triazine-1,3,5(2H,4H,6H)-tripropanamine
- EC Number:
- 240-004-1
- EC Name:
- N,N,N',N',N'',N''-hexamethyl-1,3,5-triazine-1,3,5(2H,4H,6H)-tripropanamine
- Cas Number:
- 15875-13-5
- Molecular formula:
- C18H42N6
- IUPAC Name:
- (3-{3,5-bis[3-(dimethylamino)propyl]-1,3,5-triazinan-1-yl}propyl)dimethylamine
- Test material form:
- liquid: viscous
- Details on test material:
- Batch No.: 1166046
Purity 98%
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- other: DAE 433 - mixture of 40% dimethylacetamide, 30% acetone and 30% ethanol
- Concentration:
- 5%, 10%,25% in DAE433
- No. of animals per dose:
- 5
- Details on study design:
- The test substance was administered in the form of suspension in DAE 433.
The volume of the application form was constant at all groups of animals - 25 l of the appropriate dilution to the dorsum of each ear once a day morning for 3 consecutive days. The application was performed very slowly by micropipette.
Day 1:
Open application of 25μL (in the morning, by pipette) of appropriate suspensions of the test substance, the vehicle alone or the positive control to the dorsum of each ear.
Days 2 and 3:
The application procedure repeated as carried out on day 1.
Days 4 and 5:
No treatment.
Day 6:
The weight of animals was recorded. Injection 250 μL of phosphate-buffered saline (PBS) containing 7.26 x105 Bq of 3H-methyl thymidine into all test and control mice via the tail vein. - Positive control substance(s):
- other: Dinitrochlorobenzene
- Statistics:
- For statistical calculations the software Statgraphic ® Centurion (version XV, USA) was used. Statistical evaluation of measured parameters was performed at first by applying the non-parametric Kruskal-Wallis test for the comparison of the measured effect in all treatment groups with the vehicle control group, as global test, and then the non-parametric two-group Mann-Whitney rank test (probability level 0.05) for all two-group comparisons.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Negative control
- Parameter:
- SI
- Value:
- 9.67
- Test group / Remarks:
- Positive Controls
- Parameter:
- SI
- Value:
- 1.38
- Test group / Remarks:
- 25% group
- Parameter:
- SI
- Value:
- 1.03
- Test group / Remarks:
- 10% group
- Parameter:
- SI
- Value:
- 1.01
- Test group / Remarks:
- 5% group
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Negative Control Group = 250 Positive control Group = 2418 25% solution group = 345.89 10% solution group = 257.53 5% solution group = 252.88
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the given test conditions, the test substance does not elicit a sensitising response in LLNA assay.
- Executive summary:
The positive control substance DNCB produced positive LLNA response at an exposure level expected to give an increase in the Stimulation Index SI ≥ 3 over the negative control group, which was in congruence with the expected mode of action of a contact allergen. The positive control also elicited a reaction pattern with statistically significant increase in ear weight. The negative control did not reveal any changes.These results demonstrate that the method performed in conditions of our laboratory has sufficient reliability.
The value of SI for the test groups treated by the test substance at all three dose levels is below the threshold, stimulation index
(SI) is < 3. The comparison of the Stimulation Indexes between the treated groups and the control group revealed that the test substance did not cause a statistically significant increase in radioisotope incorporation into the DNA of dividing lymphocytes. So the result of LLNA assay is negative.
The animals exposed to the test substance showed no significant skin reactions and clinical symptoms of intoxication throughout the experiment.
The test substance showed a tendency to increase ear weight with relation to the dose.Statistically significant increase of ear weight was recorded in animals at the highest and the middle dose level (25%, 10% test substance concentrations).
This weight increase is caused by irritation effect of the test substance. The result showed the skin irritation potential considered as positive – it means the test substance is skin irritant.
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