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Diss Factsheets
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EC number: 807-935-0 | CAS number: 1244733-77-4
- 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:
- 8.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 102.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- For the inhalation route there is no animal study available. Therefore, oral rat data is used to calculate a corresponding air concentration for humans and a route-to-route extrapolation for systemic effects is necessary to derive the correct starting point. In the case of oral-to-inhalation the inclusion of a TCPP specific factor of 0.8 (80% oral bioavailability; see European Union Risk Assessment Report (EU RAR) 2008) is taken forward for DNEL derivation. According to Figure R. 8-3 in the ECHA guidance on information requirements and chemical safety assessment, chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, November 2012) additional correction is needed for scaling issues: Corrected inhalatory LOAEC = oral LOAEL * 80%/100% * 1/0.38 m³ per kg and day * 6.7 m³/10 m³ * 1.4 (based on the oral LOAEL of 52 mg/kg bw/day for systemic toxicity obtained in a 90-day feeding study on rats the starting point is calculated with 102.7 mg/m³. Differences in experimental/human exposure conditions were considered with the factor 1.4 (7 days/week in animal study versus 5 days/week for workers).
- Justification:
- As the starting point for the DNEL calculation is a LOAEL according to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor for dose response relationship is 3. However, in line with the EU RAR 2008 (chapter 4.1.3.2.4: ‘Normally a further factor of 3 would be used to take into account the use of a LOAEL rather than a NOAEL. However, this is not considered necessary here, as the adverse effect in the repeated dose toxicity study (mainly liver weight changes) are not considered particularly toxicologically significant and the LOAEL is probably quite close to the NOAEL.’) a factor of 1 was chosen.
- Justification:
- In accordance with the EU RAR 2008 (chapter 4.1.3.2.4: ‘In addition, a factor to allow for semi chronic to chronic extrapolation (usually a factor of 2) was not used here. It is not considered necessary, as relatively similar effects on the liver, at doses of a comparable order of magnitude were observed in both the 28-day and the 90-day studies and so it is felt that exposure duration is not significant.’) a factor of 1 was chosen.
- Justification:
- Allometric scaling is already included in the route-to-route extrapolation for dose descriptor calculation as described in the ECHA guidance R.8.
- Justification:
- A factor of 2.5 for remaining interspecies differences is suggested in the ECHA guidance R.8.
- Justification:
- According to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor to be applied for intraspecies differences in workers is 5.
- Justification:
- Default assessment factor for good/standard quality of database as suggested by the ECHA guidance R.8.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 22.6 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 282.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- For the inhalation route there is no reliable animal study available. Therefore, oral rat data is used to calculate a corresponding air concentration for humans and a route-to-route extrapolation for systemic effects is necessary to derive the correct starting point. In the case of oral-to-inhalation the inclusion of a TCPP specific factor of 0.8 (80% oral bioavailability; see EU RAR 2008) is taken forward for DNEL derivation. According to Figure R. 8-3 in ECHA guidance R.8 additional correction is needed for scaling issues: Corrected inhalatory NOAEC = oral NOAEL * 80%/100% * 1/0.38 m³ per kg bw * 6.7 m³/10 m³ (based on the oral NOAEL of 200 mg/kg bw for systemic toxicity obtained in an acute toxicity on rats the starting point is calculated with 282.1 mg/m³.
- Justification:
- As the starting point for the DNEL calculation is a NOAEL according to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor for dose response relationship is 1.
- Justification:
- Allometric scaling is already included in the route-to-route extrapolation for dose descriptor calculation as described in the ECHA guidance R.8.
- Justification:
- A factor of 2.5 for remaining interspecies differences is suggested in ECHA guidance R.8.
- Justification:
- According to chapter R.8.4.3.1 of ECHA guidance R.8 the default AF to be applied for intraspecies differences in workers is 5.
- Justification:
- Default assessment factor for good/standard quality of database as suggested by ECHA guidance R.8.
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:
- 2.91 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 145.6 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- For the dermal route there is no animal study available. Therefore, oral rat data are used to calculate a corresponding dermal exposure dose for humans. On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation (ECHA guidance R.8, chapter 8.4.2). According to EU RAR (2008) TCPP specific bioavailabilities of 80% for the oral route and 40% for der dermal route (worst case scenario) are taken forward for DNEL derivation. Differences in experimental/human exposure conditions were considered with the factor 1.4 (7 days/week in animal study versus 5 days/week for workers)
- Justification:
- As the starting point for the DNEL calculation is a LOAEL according to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor for dose response relationship is 3. However, in line with the EU RAR 2008 (chapter 4.1.3.2.4 ‘Normally a further factor of 3 would be used to take into account the use of a LOAEL rather than a NOAEL. However, this is not considered necessary here, as the adverse effect in the repeated dose toxicity study (mainly liver weight changes) are not considered particularly toxicologically significant and the LOAEL is probably quite close to the NOAEL.’) a factor of 1 was chosen.
- Justification:
- In accordance with the EU RAR 2008 (chapter 4.1.3.2.4: ‘In addition, a factor to allow for semi chronic to chronic extrapolation (usually a factor of 2) was not used here. It is not considered necessary, as relatively similar effects on the liver, at doses of a comparable order of magnitude were observed in both the 28-day and the 90-day studies and so it is felt that exposure duration is not significant.’) a factor of 1 was chosen.
- Justification:
- According to Table R.8-3 of ECHA guidance R.8 the allometric scaling factor for the rat when compared with humans is 4.
- Justification:
- A factor of 2.5 for remaining interspecies differences is suggested in ECHA guidance R.8.
- Justification:
- According to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor to be applied for intraspecies differences in workers is 5.
- Justification:
- Default assessment factor for good/standard quality of database as suggested by ECHA guidance R.8.
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
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
The updated hazard conclusions for TCPP follow the most recent and relevant ECHA Guidance Documents. Thus, only one DNEL or qualitative hazard conclusion is derived for each type of hazard based on the lowest and most relevant NOAEL/LOAEL or qualitatively, on the most relevant critical effect for the route and exposure duration. For TCPP the experimentally derived value of 80% oral absorption and the worst-case dermal absorption rate of 40% will be taken forward to risk characterisation.
For hazard assessment relating to repeated dose toxicity of TCPP a LOAEL of 52 mg/kg bw/day is taken forward. This LOAEL is based on liver weight increases and mild thyroid follicular cell hyperplasia observed in a 13-week feeding study in rats. This LOAEL covers the LOAEL of 99 mg/kg bw/day for maternal toxicity obtained in a 2-generation reproductive toxicity feeding study in rats. For male rats, a NOAEL of approximately 85 mg/kg bw/day was derived in this study. The LOAEL of 52 mg/kg bw/day thus represents the lowest and thus, most relevant starting point.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.45 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 36.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- For the inhalation route there is no animal study available. Therefore, oral rat data is used to calculate a corresponding air concentration for humans and a route-to-route extrapolation for systemic effects is necessary to derive the correct starting point. In the case of oral-to-inhalation the inclusion of a TCPP specific factor of 0.8 (80% oral bioavailability; see EU RAR 2008) is taken forward for DNEL derivation. According to Figure R. 8-3 in ECHA guidance R.8 additional correction is needed for scaling issues: Corrected inhalatory LOAEC = oral LOAEL * 80%/100% * 1/1.15 m³ per kg and day (based on the oral LOAEL of 52 mg/kg bw/day for systemic toxicity obtained in a 90-day feeding study on rats).
- Justification:
- As the starting point for the DNEL calculation is a LOAEL according to ECHA Guidance (November 2012), R.8.4.3.1 the default assessment factor for dose response relationship is 3. However, in line with the EU RAR 2008 (chapter 4.1.3.2.4 ‘Normally a further factor of 3 would be used to take into account the use of a LOAEL rather than a NOAEL. However, this is not considered necessary here, as the adverse effect in the repeated dose toxicity study (mainly liver weight changes) are not considered particularly toxicologically significant and the LOAEL is probably quite close to the NOAEL.’) a factor of 1 was chosen.
- Justification:
- In accordance with the EU RAR 2008 (chapter 4.1.3.2.4: ‘In addition, a factor to allow for semi chronic to chronic extrapolation (usually a factor of 2) was not used here. It is not considered necessary, as relatively similar effects on the liver, at doses of a comparable order of magnitude were observed in both the 28-day and the 90-day studies and so it is felt that exposure duration is not significant.’) a factor of 1 was chosen.
- Justification:
- Allometric scaling is already included in the route-to-route extrapolation for dose descriptor calculation as described in ECHA guidance R.8.
- Justification:
- A factor of 2.5 for remaining interspecies differences is suggested in ECHA guidance R.8.
- Justification:
- According to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor to be applied for intraspecies differences in the general population is 10.
- Justification:
- Default assessment factor for good/standard quality of database as suggested by ECHA guidance R.8.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.6 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 139.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- For the inhalation route there is no animal study available. Therefore, oral rat data is used to calculate a corresponding air concentration for humans and a route-to-route extrapolation for systemic effects is necessary to derive the correct starting point. In the case of oral-to-inhalation the inclusion of a TCPP specific factor of 0.8 (80% oral bioavailability; see EU RAR 2008) is taken forward for DNEL derivation. According to Figure R. 8-3 in ECHA guidance R.8 additional correction is needed for scaling issues: Corrected inhalatory NOAEC = oral NOAEL * 80%/100% * 1/1.15 m³ per kg (based on the oral NOAEL of 200 mg/kg bw for systemic toxicity obtained in an acute toxicity on rats the starting point is calculated with 139.1 mg/m³.
- Justification:
- As the starting point for the DNEL calculation is a NOAEL according to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor for dose response relationship is 1.
- Justification:
- Allometric scaling is already included in the route-to-route extrapolation for dose descriptor calculation as described in ECHA guidance R.8.
- Justification:
- A factor of 2.5 for remaining interspecies differences is suggested in ECHA guidance R.8.
- Justification:
- According to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor to be applied for intraspecies differences in the general population is 10.
- Justification:
- Default assessment factor for good/standard quality of database as suggested by ECHA guidance R.8.
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:
- DNEL (Derived No Effect Level)
- Value:
- 1.04 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 104 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- For the dermal route there is no animal study available. Therefore, oral rat data are used to calculate a corresponding dermal exposure dose for humans. On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation (ECHA guidance R.8, chapter 8.4.2). According to EU RAR (2008) TCPP specific bioavailabilities of 80% for the oral route and 40% for der dermal route (worst case scenario) are taken forward for DNEL derivation.
- Justification:
- As the starting point for the DNEL calculation is a LOAEL according to ECHA Guidance (November 2012), R.8.4.3.1 the default assessment factor for dose response relationship is 3. However, in line with the EU RAR 2008 (chapter 4.1.3.2.4 ‘Normally a further factor of 3 would be used to take into account the use of a LOAEL rather than a NOAEL. However, this is not considered necessary here, as the adverse effect in the repeated dose toxicity study (mainly liver weight changes) are not considered particularly toxicologically significant and the LOAEL is probably quite close to the NOAEL.’) a factor of 1 was chosen.
- Justification:
- In accordance with the EU RAR 2008 (chapter 4.1.3.2.4: ‘In addition, a factor to allow for semi chronic to chronic extrapolation (usually a factor of 2) was not used here. It is not considered necessary, as relatively similar effects on the liver, at doses of a comparable order of magnitude were observed in both the 28-day and the 90-day studies and so it is felt that exposure duration is not significant.’) a factor of 1 was chosen.
- Justification:
- According to Table R.8-3 of ECHA guidance R.8 the allometric scaling factor for the rat when compared with humans is 4.
- Justification:
- A factor of 2.5 for remaining interspecies differences is suggested in ECHA guidance R.8.
- Justification:
- According to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor to be applied for intraspecies differences in the general population is 10.
- Justification:
- Default assessment factor for good/standard quality of database as suggested by ECHA guidance R.8.
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
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:
- 0.52 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 52 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Oral data from the rat are used to decide on a corresponding oral dose for humans. TCPP specific oral bioavailability of 80% for the rat is suggested to be adequate also for humans. Therefore a route-to-route extrapolation is not necessary and the LOAEL from the rat study is used as starting point.
- Justification:
- As the starting point for the DNEL calculation is a LOAEL according to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor for dose response relationship is 3. However, in line with the EU RAR 2008 (chapter 4.1.3.2.4: ‘Normally a further factor of 3 would be used to take into account the use of a LOAEL rather than a NOAEL. However, this is not considered necessary here, as the adverse effect in the repeated dose toxicity study (mainly liver weight changes) are not considered particularly toxicologically significant and the LOAEL is probably quite close to the NOAEL.’) a factor of 1 was chosen.
- Justification:
- In accordance with the EU RAR 2008 (chapter 4.1.3.2.4: ‘In addition, a factor to allow for semi chronic to chronic extrapolation (usually a factor of 2) was not used here. It is not considered necessary, as relatively similar effects on the liver, at doses of a comparable order of magnitude were observed in both the 28-day and the 90-day studies and so it is felt that exposure duration is not significant.’) a factor of 1 was chosen.
- Justification:
- According to Table R.8-3 of ECHA guidance R.8 the allometric scaling factor for the rat when compared with humans is 4.
- Justification:
- A factor of 2.5 for remaining interspecies differences is suggested in ECHA guidance R.8.
- Justification:
- According to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor to be applied for intraspecies differences in the general population is 10.
- Justification:
- Default assessment factor for good/standard quality of database as suggested by ECHA guidance R.8.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEL
- Explanation for the modification of the dose descriptor starting point:
- Oral data from the rat are used to decide on a corresponding oral dose for humans. The NOAEL of 200 mg/kg bw obtained in an acute oral toxicity study is taken forward. TCPP specific oral bioavailability of 80% for the rat is suggested to be adequate also for humans. Therefore a route-to-route extrapolation is not necessary and the NOAEL from the rat study is used as starting point.
- Justification:
- As the starting point for the DNEL calculation is a NOAEL according to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor for dose response relationship is 1.
- Justification:
- Allometric scaling is already included in the route-to-route extrapolation for dose descriptor calculation as described in ECHA guidance R.8.
- Justification:
- A factor of 2.5 for remaining interspecies differences is suggested in ECHA guidance R.8.
- Justification:
- According to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor to be applied for intraspecies differences in the general population is 10.
- Justification:
- Default assessment factor for good/standard quality of database as suggested by ECHA guidance R.8.
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The updated hazard conclusions for TCPP follow the most recent and relevant ECHA Guidance Documents. Thus, only one DNEL or qualitative hazard conclusion is derived for each type of hazard based on the lowest and most relevant NOAEL/LOAEL or qualitatively, on the most relevant critical effect for the route and exposure duration. For TCPP the experimentally derived value of 80% oral absorption and the worst-case dermal absorption rate of 40% will be taken forward to risk characterisation.
For hazard assessment relating to repeated dose toxicity of TCPP a LOAEL of 52 mg/kg bw/day is taken forward. This LOAEL is based on liver weight increases and mild thyroid follicular cell hyperplasia observed in a 13-week feeding study in rats. This LOAEL covers the LOAEL of 99 mg/kg bw/day for maternal toxicity obtained in a 2-generation reproductive toxicity feeding study in rats. For male rats, a NOAEL of approximately 85 mg/kg bw/day was derived in this study. The LOAEL of 52 mg/kg bw/day thus represents the lowest and thus, most relevant starting point.
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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