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Diss Factsheets
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EC number: 213-834-7 | CAS number: 1025-15-6
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.35 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 26.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- According to QSAR predictions obtained from the Danish (Q)SAR database (2004), gastrointestinal absorption is presumed to be 100 %. The observation of toxicity following acute and subacute exposure via gavage administration of triallyl isocyanurate confirms a high substance absorption after oral intake. The inhalative absorption is considered to be in the same order of magnitude as the oral absorption. Therefore no additional factor is applied for differences between the oral and inhalative intake.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default conversion AF subacute to chronic exposure.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- There is no evidence for species differences in the general mode of action or kinetics. However, standard AF is applied.
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for the worker.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole database is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further AFs are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- The absorption difference for the dermal route compared to the oral route is adjusted by the factor 2 due to a moderate skin absorption potential (0.007 mg/cm²/h) assigned to a dermal absorption of 50% based on the QSAR results for triallyl isocyanurate taking into account molecular weight, log Pow and water solubility.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default conversion AF subacute to chronic exposure.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling factor for differences between rats and humans.
- AF for other interspecies differences:
- 2.5
- Justification:
- There is no evidence for species differences in the general mode of action or kinetics. However, standard AF is applied.
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for the worker.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole database is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further AFs are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Workers might be exposed to triallyl isocyanurate (liquid) during manufacture, processing, loading or filling in appropriate containers. During formulation, triallyl isocyanurate-coated silica particles (dust) containing 70 % triallyl isocyanurate are obtained.
In general, the calculation of a DNEL is based on the observed effect level which has to be modified as described in “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health” (ECHA, December 2010). Dermal and inhalative intakes are the possible exposure routes for workers.
The establishment of an acute toxicity DNEL set for effects occurring after a single exposure of a few minutes up to 24 hours is unnecessary for triallyl isocyanurate, as the long-term DNEL is sufficient to ensure, that these effects do not occur. Triallyl isocyanurate has a very low vapour pressure (2002-0726-DKP) at room temperature and e.g. at a process temperature of 38 °C (0.00017 Pa at 20 °C and 0.0076 Pa at 38 °C) and as a consequence, the formation of aerosols can be considered negligible. Thus, peak exposure significantly higher than the average daily exposure and the long-term DNEL are very unlikely. In addition since triallyl isocyanurate did not show any irritating effects, no DNELs for local effects were derived.The assessment of hazards for acute systemic effects and local effects are sufficiently covered by derivation of the DNEL for long-term systemic exposure.
As starting point for derivation of the DNEL, a NOAEL of 15 mg/kg bw/day (for systemic effects) was used which was found in a subacute toxicity study performed according to OECD 407 (2003-0756-FGT). In this GLP guideline study triallyl isocyanurate was administered via gavage at concentrations of 5, 15 and 50 mg/kg bw/day for 28 days. Additional satellite animals for the control, mid and high dose group for observation of reversibility, persistence or delayed occurrence of toxic effects were included for 14 days post treatment. A NOAEL of 15 mg/kg/day for male rats was derived based on the significant histopathological changes in the liver still present after the recovery period in the 50 mg/kg bw/day group. A NOAEL of ≥50 mg/kg bw/day is applied for females due to no adverse effects observed after the recovery period. The liver was identified as target organ. Based on sensitivity, the NOAEL value for male rats was selected as relevant dose descriptor.
Inhalation
For calculation of the DNEL for long-term inhalative systemic effects, the dose descriptor has to be converted into a corrected starting point by route-to-route extrapolation.
According to QSAR predictions obtained from the Danish (Q)SAR database (2004), gastrointestinal absorption is presumed to be 100 %. The observation of toxicity following acute and subacute exposure via gavage administration of triallyl isocyanurate confirms a high substance absorption after oral intake. The inhalative absorption is considered to be in the same order of magnitude as the oral absorption. Therefore no additional factor is applied for differences between the oral and inhalative intake.
Besides this, the interspecies difference between rat and human has to be taken into account. Therefore, the no observed effect level has to be corrected by the risk assessor 6.7 / (0.38*10) regarding breathing volume and frequency. Thus, the corrected starting point for workers was 26.4 mg/m³/day for inhalation.
Subsequently assessment factors (AF) are listed, which have to be taken into account for the final DNEL calculation: remaining interspecies-differences (2.5), intraspecies differences (5), duration extrapolation: subacute - chronic (6).
The DNEL is calculated according to the formula DNEL = (corrected starting point)/(overall AF). Thus, the resulting DNEL for long-term inhalative systemic effects is 0.35 mg/m³ for workers.
Dermal
For calculation of the DNEL for long-term dermal systemic effects, the dose descriptor has to be converted into a corrected starting point by route-to-route extrapolation. The absorption difference for the dermal route compared to the oral route is adjusted by the factor 2 due to a moderate skin absorption potential (0.007 mg/cm²/h) assigned to a dermal absorption of 50% based on the QSAR results for triallyl isocyanurate taking into account molecular weight, log Pow and water solubility (for details refer to IUCLID chapter 7.1 toxicokinetics, metabolism and distribution). Thus the corrected starting point for workers was 30 mg/kg bw/day for the dermal route.
Subsequently, following assessment factors are taken into account for the final DNEL calculation: interspecies differences (4), remaining interspecies-differences (2.5), intraspecies differences (5) and duration extrapolation: subacute - chronic (6).
As a consequence, the resulting DNEL for long-term dermal systemic effects is 0.1 mg/kg bw/day for workers.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.18 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 26.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- According to QSAR predictions obtained from the Danish (Q)SAR database (2004), gastrointestinal absorption is presumed to be 100 %. The observation of toxicity following acute and subacute exposure via gavage administration of triallyl isocyanurate confirms a high substance absorption after oral intake. The inhalative absorption is considered to be in the same order of magnitude as the oral absorption. Therefore no additional factor is applied for differences between the oral and inhalative intake.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default conversion AF subacute to chronic exposure.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- There is no evidence for species differences in the general mode of action or kinetics. However, standard AF is applied.
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole database is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further AFs are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.05 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- The route of exposure is identical.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default conversion AF subacute to chronic exposure.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling factor for differences between rats and humans.
- AF for other interspecies differences:
- 2.5
- Justification:
- There is no evidence for species differences in the general mode of action or kinetics. However, standard AF is applied.
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole database is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further AFs are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Direct exposure of the general public via inhalative and dermal route is precluded. However, as the substance is classified with R48 the assessment of man via environment is required according to ECHA guidance. Thus, a DNELs for the general population addressing exposure via oral route is derived.
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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