Phosphorus

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

4 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Acute/short term exposure

DNEL related information

Local effects

Acute/short term exposure

DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

30 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Acute/short term exposure

DNEL related information

Additional information - workers

Acute DNELs

According to RIP 3.2.2, Chapter R8, R8.1.2.5, p. 16 no acute DNELs were derived since no acute toxicity hazard has been identified. The long-term DNEL also covers possible acute toxic effects.

DNEL derivation

Since elemental Red Phosphorus is not systemically bioavailable (for details please refer to Chapter 7.1) no DNEL is derived from higher tier studies. Only the oxidized Phosphorus species (PO₂^3-, PO₃^3-, PO₄^{3 –}) are able to cross the gut wall/penetrate membranes and enter the organism in a minimal amount (1.3 % of the applied Phosphorus dose). Phosphate is known to be a food additive and an ADI(Acceptable Daily Intake) value for the general population based on Phosphate toxicity data is available. According to the FAO/WHO (Food and Agriculture Organization of the United Nations/World Health Organization) it is set at 30-70 mg Phophorus/kg bw (FAO Nutrition Meetings, Report Series No. 48A, WHO/FOODADD/70.39 June 1970 and Report Series No. 17, May 1998). In general, the ADI is a very conservative approach and applicable on the general population (incl. children, pregnant women and the elderly population). Therefore, it is justified to use this value instead of a long-term oral DNEL for humans (workers as well as consumers).

Long-term dermal systemic DNEL based on ADI(derived by FAO/WHO Expert Commitee):
- DNEL(dermal) derived according to “Guidance on information requirements and chemical safety assessment”, Chapter R8-2, Example B.5 (p. 69).
corrected DNEL(dermal)            =ADI(oral, human) x Absorption(oral-human)/Absorption(dermal-human)
                                                  = 30 mg/kg bw x 100%/100%
                                                  = 30 mg/kg bw
- since this DNEL(dermal) is derived from an accepted ADI which includes valid toxicity data as well safety factors, the application of further assessment factors is not necessary.
=> =30 mg/kg bw/d

 

Long-term inhalatory DNEL based on ADI (derived by FAO/WHO Expert Commitee):
- DNEL(inhalation) derived based on the following assumptions

ADI                            = 30 mg/kg bw/d

Average body weight   = 70 kg (according to “Guidance on information requirements and chemical safety assessment”, Chapter R8.4.3.1, p. 30) 

=>acceptable daily systemic dose= 30 mg/kg bw/d x 70 kg =2100 mg/d

Respiratory volume (worker, 8h, light activity) = 10 m³/person (according to “Guidance on information requirements and chemical safety assessment”, Chapter R8.4.2, Table R8-2, p. 26)

 

=>DNEL(inhalation)= 2100 mg / 10 m³=210 mg/m³

 

The calculated DNEL(inhalation) is very unlikely to occur. Working in an atmosphere containing 210 mg/m³ Red Phosphorus dust is not practicable. Therefore, in order to follow the most conservative approach the general threshold limit value for dust for the inhalable fraction, 4 mg/m³ as recommended by the German MAK Commission (please refer to “Deutsche Forschungsgemeinschaft, MAK- und BAT-Werte-Liste, Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe, Mitteilung 46, Willey-VCH Verlag GmbH , 2010; p. 187), was chosen as DNEL(inhalation).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

4 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Acute/short term exposure

DNEL related information

Local effects

Acute/short term exposure

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

30 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Acute/short term exposure

DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

30 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Acute/short term exposure

DNEL related information

Additional information - General Population

Acute DNELs

According to RIP 3.2.2, Chapter R8, R8.1.2.5, p. 16 no acute DNELs were derived since no acute toxicity hazard has been identified. The long-term DNEL also covers possible acute toxic effects.

DNEL derivation

Since elemental Red Phosphorus is not systemically bioavailable (for details please refer to Chapter 7.1) no DNEL is derived from higher tier studies. Only the oxidized Phosphorus species (PO₂^3-, PO₃^3-, PO₄^{3 –}) are able to cross the gut wall/penetrate membranes and enter the organism in a minimal amount (1.3 % of the applied Phosphorus dose). Phosphate is known to be a food additive and an ADI(Acceptable Daily Intake) value for the general population based on Phosphate toxicity data is available. According to the FAO/WHO (Food and Agriculture Organization of the United Nations/World Health Organization) it is set at 30-70 mg Phosphorus/kg bw (FAO Nutrition Meetings, Report Series No. 48A, WHO/FOODADD/70.39 June 1970 and Report Series No. 17, May 1998). In general, the ADI is a very conservative approach and applicable on the general population (incl. children, pregnant women and the elderly population). Therfore, it is justified to use this value instead of a long-term oral DNEL for humans (workers as well as consumers).

 

Long-term oral systemic DNEL based on ADI(derived by FAO/WHO Expert Commitee):
30 mg/kg bw/d
- since this DNEL(oral) is derived from an accepted ADI which includes valid toxicity data as well safety factors, the application of further assessment factors is not necessary.
=> =30 mg/kg bw/d

Long-term dermal systemic DNEL based on ADI (derived by FAO/WHO Expert Commitee):
- DNEL(dermal) derived according to “Guidance on information requirements and chemical safety assessment”, Chapter R8-2, Example B.5 (p. 69).
corrected DNEL(dermal)            =ADI(oral, human) x Absorption(oral-human)/Absorption(dermal-human)
                                                  = 30 mg/kg bw x 100%/100%
                                                  = 30 mg/kg bw
- since this DNEL(dermal) is derived from an accepted ADI which includes valid toxicity data as well safety factors, the application of further assessment factors is not necessary.
=> =30 mg/kg bw/d

 

Long-term inhalatory DNEL based on ADI (derived by FAO/WHO Expert Commitee):
- DNEL(inhalation) derived based on the following assumptions

ADI                            = 30 mg/kg bw/d

Average body weight   = 70 kg (according to “Guidance on information requirements and chemical safety assessment”, Chapter R8.4.3.1, p. 30)

 

=>acceptable daily systemic dose= 30 mg/kg bw/d x 70 kg =2100 mg/d

Respiratory volume (24h) = 20 m³/person (according to “Guidance on information requirements and chemical safety assessment”, Chapter R8.4.2, Table R8-2, p. 26)

 

=>DNEL(inhalation)= 2100 mg / 20 m³=105 mg/m³

 

The calculated DNEL(inhalation) is very unlikely to occur. The stay in an atmosphere containing 105 mg/m³ Red Phosphorus dust is not practicable.

Therefore, in order to follow the most conservative approach the general threshold limit value for dust for the inhalable fraction, 4 mg/m³ as recommended by the German MAK Commission (please refer to “Deutsche Forschungsgemeinschaft, MAK- und BAT-Werte-Liste, Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe, Mitteilung 46, Willey-VCH Verlag GmbH , 2010; p. 187), was chosen as DNEL(inhalation).