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EC number: 219-514-3 | CAS number: 2451-62-9
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to valid guidelines and was performed under GLP. All necessary parameters have been documented including the sensitivity of the Guinea pig strain
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study carried out prior to REACH regulation
Test material
- Reference substance name:
- 1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- EC Number:
- 219-514-3
- EC Name:
- 1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- Cas Number:
- 2451-62-9
- Molecular formula:
- C12H15N3O6
- IUPAC Name:
- tris[(oxiran-2-yl)methyl]-1,3,5-triazinane-2,4,6-trione
- Details on test material:
- TK 10622 (TGIC) , Triglycidyl Isocyanurate.
Purity: commercial grade (> 93%), Batch number 80507178
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Albino Dunkin Hartley Guinea pigs (HsdPoc: DH, SPF strain)
The male guinea pigs were of 5-7 weeks of age, and weighed 382-502 gm, acclimatization was 1 week, one animal used for intradermal, 2 animals for epidermal pre-tests
Animals kept under standard laboratory conditions such as 15 air changes per hour, 22 +/-3 °C, 40-70% humidity, 12hour light/dark cycle, and individually in Macrolon type-3 cages with soft wood bedding
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Freunds’ adjuvant (FDA) / saline (1:1), corn oil
- Concentration / amount:
- The optimal concentrations were 5% for intradermal , and 30 %/25% for epidermal applications. (induction)
a concentration of 25% in corn oil was used. (challenge)
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: Freunds’ adjuvant (FDA) / saline (1:1), corn oil
- Concentration / amount:
- The optimal concentrations were 5% for intradermal , and 30 %/25% for epidermal applications. (induction)
a concentration of 25% in corn oil was used. (challenge)
- No. of animals per dose:
- 10 control & 20 dosed
- Details on study design:
- The sensitivity of the strain of guinea pigs was regularly tested with α-hexylcinnamaldehyde
TK 10622 (TGIC) was dissolved in corn oil or suspended in FDA/saline (1:1).
Scoring of the skin reactions was performed according to Draize (1959).
In a pre-test the lowest irritating concentration for intradermal and epidermal applications were established in one and 2 male guinea pigs. The optimal concentrations were 5% for intradermal , and 30 %/25% for epidermal applications.
Intradermal application was performed by mixing 5% TGIC in FDA/saline, and intradermal injection. Epidermal application was performed by placing a filter paper soaked with 0.2 ml (2x2 cm) on the shaved skin of the flanks of the animals at a concentration of 30% in corn oil. For challenge applications, a concentration of 25% in corn oil was used.
For the intradermal induction, a 6x8 cm area of the dorsal skin was clipped free of hair, and three pairs of injections were made: FDA/saline mixture, Test article in corn oil (5%), test article in FDA/saline (5%); the control animals received the same injections, but without TGIC.
Epidermal application was performed on day 8, on the previously clipped skin area with a 2x4 cm filter paper soaked with a 30% solution of TGIC in corn oil (0.3 ml), and covered with an elastic bandage for 48 hours. Control animals received the same treatment but without TGIC. Skin reactions were assessed 24 and 48 hours following removal of the dressing.
The first challenge application was performed on day 14 following the first application, and epidermal patches of 2x2 cm of filter paper soaked with TGIC dissolved in corn oil (0.2 ml) was placed on the shaved skin and covered with an elastic bandage for 24 hours. After removal of the bandage, the skin was depilated and scores were made at 24 and 48 hours post removal.
The second challenge application was performed on day 29, using the same procedure as for the first challenge.
Readings of the score were made 24 and 48 hours after removal of challenge patches under fluorescent light.
No statistical analysis was performed on the data - Challenge controls:
- Control animals received the same treatment but without TGIC.
- Positive control substance(s):
- yes
- Remarks:
- α-hexylcinnamaldehyde.
Results and discussion
- Positive control results:
- ca. 80 % of the animals were sensitized
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30 % for epidermal challenge.
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- slight erythemas
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 % for epidermal challenge.. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: slight erythemas .
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- TGIC was a weak sensitizer under the conditions of the test
- Executive summary:
Using the modified Maximisation assay according to OECD guideline 406, TGIC showed only weak skin sensitizing properties in Guinea pigs, as only 25 and 5% of the animals showed weak reaction to first and second challenge inductions
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