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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 701-374-4 | CAS number: -
- 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:
- 70.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 762.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Extrapolated from oral toxicity study. Substance's vapor pressure is too low to test via inhalation. Default assessment factors.
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:
- 50 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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 5 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Key Study: RTI Modified OECD 422 Design of TDP (Tyl 2005), Oral (gavage) exposure in rats
Dose Descriptor: NOAEL (systemic toxicity) = 1,000 mg/kg/day
Corrected Dermal NOAEL = Oral NOAEL x (ABSoral-rat/ ABSdermal-human)
= 1000 mg/kg/day x (5)[1]
Corrected Dermal NOAEL = 5000 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= 5000 mg/kg/day ÷ 100
DNELDermal - Long-Term Systemic= 50.0 mg/kg/day
[1] Extrapolated from oral study (assume 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:
- 5
- AF for the quality of the whole database:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 338.33 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Dose descriptor:
- other: LOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 338.33 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- Overall assessment factor (AF):
- 30
- Dose descriptor starting point:
- other: LOAEL
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Acute Effects
PDDP is demonstrated to have a low order of acute toxicity. DNELs for acute systemic toxicity should only be derived if an acute toxicity hazard, leading to classification and labelling (e.g. under EU CLP or DSD regulations), has been identified and there is a potential for high peak exposures (this is only usually relevant for inhalation exposures). As no acute hazard has been identified, then a DNEL for acute toxicity is unnecessary as the long-term DNEL will normally be sufficient to ensure that adverse effects do not occur. Consequently, no worker-DNELs for acute toxicity have been calculated.
Sensitisation
PDDP is a skin sensitiser. As such, a DNEL for localised dermal effects has been established.
The basis for the local dermal DNEL is the LLNA EC3 of 40.6% (Harlan 2010) using the scaling equation provided by ECHA:
EC3[%] * 250 [µg/cm²/%] = EC3 [µg/cm²]
Given that PDDP will be classified as skin irritant and a skin sensitiser, dermal exposure to the worker should be minimal due to dermal PPE (e.g., gloves).
PDDP has a very low vapour pressure and respiratory exposure is not anticipated to occur to any significance.
Derivation of the Systemic DNELs
The basis for the systemic DNELs is the NOAEL of 1000 mg/kg/day (rats) from the repeat dose toxicity study of triisodecyl phosphite (TDP) (Tyl 2005). TDP is a constituent of commercial PDDP and a structural analog to the other constituents, so these data can be appropriately applied to PDDP. This selection of NOAEL is further supported by the repeat-dose NOAEL of 1000 mg/kg/day of PDDP in a neurotoxicity study in hens. 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.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 35 mg/m³
- 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:
- 1 000 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 765 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Extrapolated from oral toxicity study. Substance's vapor pressure is too low to test via inhalation. Default assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 5 000 mg/kg bw/day
- 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
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)
- Most sensitive endpoint:
- sensitisation (skin)
General Population - Hazard via oral route
Systemic 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 for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
Based on use patterns and chemical characteristics exposure to the general population is not expected to be significant.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.