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Diss Factsheets
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EC number: 278-758-9 | CAS number: 77745-66-5
- 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
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:
- 4.4 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 110.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Inhalation - Long-Term Systemic Effects
Key Study: JRF (2019), 90-day oral (gavage) exposure in rats
Dose Descriptor: NOAEL (systemic toxicity) = 125 mg/kg/day
Corrected Inhalation NOAEL = Oral NOAEL x (1/sRVrat)[a]x (ABSoral-rat/ ABSinhl-human)
= 125 mg/kg/day x (1 / 0.38m3kg-18hr-1) x (0.5)[b]
Corrected Inhalation NOAEL = 164.5 mg/m3 for 8hr
Corrected Inhalation NOAEL (workers) = 164.5 x (sRVhuman/ wRV)[c]
= 164.5 x (6.7 / 10)
Corrected Inhalation NOAEL (workers) = 110.2 mg/m3 for 8hr
Assessment Factors: Interspecies 2.5 (remaining differences)
Intraspecies 5 (ECTOC recommendation)
Exposure Duration 2 (subchronic to chronic)
Dose Response 1
Quality of Database 1
Total Assessment Factor: 25
DNELInhl - Long-Term Systemic= 110.2 mg/m3 for 8hr ÷ 25
DNELInhl - Long-Term Systemic= 4.4 mg/m3 for 8hr
[a]Standard respiratory volume (rat) = 0.38 m3/kg for 8 hours.
[b]Default assumption: inhalation absorption in humans is twice the oral absorption in rats.
[c]Standard respiratory volume (human) = 6.7 m3for 8 hours; worker respiratory volume = 10 m3for 8 hours
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.25 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 625 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Extrapolated from oral study (assume 50% oral and 10% dermal absorption). Standard assessment factors used.
Dermal - Long-Term Systemic Effects
Key Study: JRF (2019), 90-day oral (gavage) exposure in rats
Dose Descriptor: NOAEL (systemic toxicity) = 125 mg/kg/day
Corrected Dermal NOAEL = Oral NOAEL x (ABSoral-rat/ ABSdermal-human)
= 125 mg/kg/day x (0.5/0.1)[1]
Corrected Dermal NOAEL = 625 mg/kg/day
Assessment Factors: Interspecies 4 (allometric scaling)
2.5 (remaining differences)
Intraspecies 5 (REACH guidance)
Exposure Duration 2 (subchronic to chronic)
Dose Response 1
Quality of Database 1
Total Assessment Factor: 100
DNELDermal - Long-Term Systemic= 625 mg/kg/day ÷ 100
DNELDermal - Long-Term Systemic= 6.25 mg/kg/day
[1]Default assumption: dermal absorption in humans = 10%; oral absorption in rats = 50%.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 767.5 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Dose descriptor:
- other: EC3, EC3 [%]*250 [μg/cm2/% ] = EC3 [μg/cm2]
- Value:
- 23 mg/m³
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 10
- AF for intraspecies differences:
- 3
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 767.5 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Dose descriptor starting point:
- other: EC3, EC3 [%]*250 [μg/cm2/% ] = EC3 [μg/cm2]
- Value:
- 23 mg/m³
- AF for dose response relationship:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 10
- AF for intraspecies differences:
- 3
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Acute DNELs
There were no signs of acute toxicity by either the oral, inhalation or dermal routes. As such, it is not necessary or appropriate to establish acute DNELs.
Dermal Local DNELs
TiTDP test positive in an LLNA skin sensitisation study. The EC3 concentration was 92.1%. The DNEL has derived as follows:
DNEL = EC3[%] * 250 [µg/cm²/%] / AF = 92.1% * 250 µg/cm²/% / 30 = 767.5 µg/cm²
Long-Term Systemic DNELs
The basis for the long-term systemic DNELs is the NOAEL of 125 mg/kg/day (top dose) from the JRF (2019) oral gavage 90 -day subchronic study in rats.The inhalation and dermal DNELs were extrapolated from the oral study using standard route-to-route extrapolations and assuming 50% oral and inhalation absorption and 10% dermal absorption.
Substance Class
TiTDP is one of several structurally related alkyl phosphites. Alkyl phosphites are characterized by a phosphorus atom connected to three alkyl ester groups (oxygen connected to an alkyl chain). The closest alkyl phosphite structural analog to TiTDP is triisodecyl phosphite (TDP). The alkyl groups on TDP are branched,C10, isomers and the alkyl groups on TiTDP are branched, C13, isomers. TDP as a data-rich member of this class of phosphites is an important source of analog or read-across data for TiTDP.
Relationship Between Alkyl Phosphites and Alkyl Alcohols
These alkyl phosphites are manufactured using a class of alkyl alcohols that have been well studied and previously accepted as a category (Long Chain Alcohols Category under the OECD SIDS program; Alkyl Alcohols C6 to C13 Category under the U. S. High Production Volume (HPV) program). The category assessment and associated use of read-across data for these alkyl alcohols is particularly relevant for the alkyl phosphites because these phosphites readily hydrolyze into the associated alcohol used in the manufacture of the phosphite – TDP to isodecanol (C10), TiTDP to isotridecanol (C13). Given this, it appears appropriate to consider both the category approach that was used to assess the alkyl alcohols under REACH as well as the data on the relevant alcohols as analogs to TITDP and the related phosphites.
Read-Across Justification
A matrix comparing TDP data, TiTDP data, and their associated alkyl alcohol data is provided in as separate report in Section 13. For toxicity endpoints where there are corresponding data between TDP and TiTDP – acute oral toxicity, skin irritation, eye irritation, skin sensitisation, repeat-dose toxicity, in vitro genetic toxicity, in vivo genetic toxicity – the two chemicals generally have similar results with the same resulting classifications. Likewise in hydrolysis testing, both TDP and TiTDP showed the ability to rapidly hydrolyse in simulated stomach acid. Given the similarities in toxicities and hydrolytic characteristics plus the established relationship between their corresponding alkyl alcohols, it is appropriate to treat these substances as chemical analogues.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.7 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 287.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Standard adjustment assuming 50% absorption of human inhaled dose and 100% absorption of rat ingested dose. See full derivation below.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.125 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 625 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Extrapolated from oral study assumes 50% oral and 10% dermal absorption.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 767.5 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Dose descriptor:
- other: EC3,
- Value:
- 23 mg/m³
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 10
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.625 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
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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