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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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.