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Diss Factsheets
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EC number: 242-768-1 | CAS number: 19035-79-1
- 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:
- 10 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:
- 800 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 987 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated exposure by the inhalation route. The recommended approach is using oral data and assuming 50 % absorption by the oral route (rat) and 100 % absorption by the inhalative absorption in human.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default extrapolation factor for exposure duration is used: subchronic (starting point) to chronic (end point).
- 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:
- additional species differences including toxicodynamics
- AF for intraspecies differences:
- 5
- Justification:
- Intraspecies differences of worker are considered to be fully covered by the selected factor.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- sensitisation (skin)
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:
- 56 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:
- 800 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 5 600 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated dermal exposure. NOAEL dermal could be calculated considering experimental data (section 7.1). Experimental data showed 30 – 40 % oral absorption. As a worst case this value was set to 50%. Thus, a 50 % as worst-case figure was considered for oral absorption. Additionally, 9 % dermal absorption was obtained rounded to 10 % dermal absorption. Therefore a ratio of 5 between oral and dermal absorption was considered. Correction for difference between human and experimental exposure conditions (7 d rat/5 d worker) was included.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default extrapolation factor for exposure duration is used: subchronic (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- species differences including toxicodynamics
- AF for intraspecies differences:
- 5
- Justification:
- The default value for the relatively homogenous group "worker" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Acute/short-term exposure - systemic effects
According to the ECHA document "Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health", a DNEL for acute systemic toxicity should only be derived if an acute systemic toxicity hazard leading to classification is identified.
For potassium hexadecyl hydrogen phosphate no experimental data for the inhalation route are available and not required according to REACH regulation. Further, no acute dermal and oral toxicity up to 2000 and 5000 mg/kg bw, respectively, was observed in rats. Therefore, potassium hexadecyl hydrogen phosphate is not subject to classification for acute toxicity according to Regulation No 1272/2008, and consequently the derivation of worker DNELs for acute/short-term exposure - systemic effects is not required.
Acute/short-term and long-term exposure - local effects
Worker local DNELs for dermal and inhalation route do not need to be derived. Based on the available toxicological information, potassium hexadecyl hydrogen phopahate is not subjected to classification for skin irritation, respiratory irritation or sensitisation but for eye irritation Cat. 1. (with consequent RMM (Risk Minimizing Measures) to be applied as indicated in the CSR). Although this might imply a hazard to mucoal membrane, no local hazards after inhalation are expected based on the physical/ chemical properties of the substance (low vapour pressure, non inhalable particles based on particle size distribution).
Long-term exposure - systemic effects
Dermal route
The NOAEL long-term, dermal determined is 5600 mg/kg bw/day. It was calculated from a NOAEL long-term (subchronic), oral of 800 mg/kg bw/day determined in a subchronic repeated dose toxicity oral study and considering the experimental data (section 7.1). The experiental data showed 30 – 40 % oral absorption. A 50 % as worst-case figure was considered for oral absorption. Additionally, 9 % dermal absorption was obtained rounded to 10 % dermal absorption. Therefore a ratio of 5 between oral and dermal absorption was considered -> 800 mg/kg bw/day x 5 = 4000 mg/kg bw/day. Correction for difference between human and experimental exposure conditions: 7 d rat/5 d worker
= 4000x1.4= 5600 mg/kg bw/day
Assessemnt factors applied:
Interspecies AF, allometric scaling (rat to human): 4
Interspecies AF, remaining differences: 2.5
Intraspecies AF (worker): 5
Exposure duration AF: 2
-> Long term systemic dermal DNEL, workers = 5600 mg/kg bw/day : 100 = 56 mg/kg bw/day.
Inhalation route
According to ECHA guidance document CSA: R8, for dust as in the case with potassium hexadecyl hydrogen phopshate, if the derived DNEL for inhalation is above the general dust limit (10 mg/m³), then the general dust limit should be applied. As the calculated DNEL long term inhalation was determined to be 39.5 mg/m³ (see below *), the DNEL considered for risk characterisation is the general dust limit – 10 mg/m³.
* An inhalation NOAEC was derived from NOAEL oral value of 800 mg/kg bw/day (determined in a subchronic repeated dose toxicity oral study with rats. The oral NOAEL of 800 mg/kg bw/day was converted to an inhalation NOAEC, assuming 100% absorption via the lung and 50 % absorption via the oral route (worst-case figure, see in the endpoint summary discussion IUCLID section 7.1)
Correction for difference between human and experimental exposure conditions: 7 d rat/5 d worker
The oral NO(A)EL was converted into an inhalation NO(A)EC according to the following formula assuming a daily exposure period of 8 hours during light activity:
inhalation NO(A)EC = oral NO(A)EL × 1/sRV(rat) × ABSoral(rat)/ABSinhalation(human) × sRV(human)/wRV(human) x 1.4
oral NO(A)EL: 800 mg/kg bw/day
sRV(rat): 0.38 m³/kg bw (8 hours) [standard respiratory volume of the rat]
ABSoral(rat)/ABSinhalation (human): 2 [ratio of oral absorption in the rat to inhalative absorption in the human]
sRV(human)/wRV(human): 6.7 m³/10 m³ [ratio of human standard respiratory volume to worker respiratory volume]
Accordingly, the oral NO(A)EL of 800 mg/kg bw/day was transformed in an inhalation NO(A)EC of 987 mg/m³.
Long term systemic inhal DNEL (worker) = 987 mg/m³ / 25 = 39.5 mg/m³ - Dust limit of 10 mg/m³ was used.
General Population - Hazard via inhalation 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
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:
- no hazard identified
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
Derivation of general population DNELs is not required. Consumer use of the substance potassium hexadecyl hydrogen phosphate by the general population is intended for cosmetic purposes only. The substance is a component of a cosmetic product (an oil-in-water anionic emulsifier in cosmetic preparations). Therefore the consumer use of the substance is covered by the cosmetic legislation and not by REACH regulation as indicated in REACH regulation (EC) No. 1907/2006 Article 2 section 6.
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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