Registration Dossier
Registration Dossier
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EC number: 200-386-2 | CAS number: 58-56-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.9 mg/m³
- Most sensitive endpoint:
- neurotoxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: The ECHA REACH Guidance has been used to adapt the European Food Safety Authority's (EFSA) established tolerable upper intake level for humans (SCF, 2000).
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- other: Tolerable Upper Intake Level (UL)
- Value:
- 0.35 mg/kg bw/day
- Modified dose descriptor starting point:
- other: Corrected NAEC worker
- Value:
- 1.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The UL value derived by EFSA is 25 mg/d for an adult (SCF, 2000). This was divided by a bodyweight of 70 kg to give the dose descriptor value in units mg/kg bw/day. The bodyweight of 70 kg is the standard value for a human worker as given in Table R.8-18 of the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health.
The UL of 25 mg/d (0.35 mg/kg bw/d) is used as the starting point. As this UL is based on human studies with supplement use (oral exposure), route to route extrapolation is employed for DNEL derivation after inhalation exposure. The UL is equivalent to oral NAEL.
According the ECHA Guidance Chapter R.8, Example R.8-2, the NAEL (No Adverse Effect Level) human has to be divided by 10 m3/person to get the NAEC (No Adverse Effect Concentration) (8 h).
10 m3 is the respiratory volume (light activity) for worker (8 h exposure).
It is assumed that inhalation absorption of Pyridoxine HCl is at worst 100%, whereas oral bioavailability has been shown to be around 75%. Therefore an additional factor of 0.75 is used for correction.
The corrected dose descriptor (NAEC worker) for inhalation was calculated in accordance with the ECHA Guidance mentioned above.
NAEC worker = oral NAEL x (ABSoral / ABSinh) x (1 / wRV)
NAEC worker = 25 mg/d x (0.75/1) / 10 m3/day = 1.9 mg/m3
Where:
ABS: Absorption
wRV: worker Respiratory Volume (light activity)
Default parameters:
wRV (8 h): 10 m3/ person
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:
- 1.05 mg/kg bw/day
- Most sensitive endpoint:
- neurotoxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: The ECHA REACH Guidance has been used to adapt the European Food Safety Authority's (EFSA) established tolerable upper intake level for humans (SCF, 2000).
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- other: Tolerable Upper Intake Level (UL)
- Value:
- 0.35 mg/kg bw/day
- Modified dose descriptor starting point:
- other: Tolerable Upper Intake Level (UL)
- Value:
- 1.05 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The UL value derived by EFSA is 25 mg/d for an adult (SCF, 2000). This was divided by a bodyweight of 70 kg to give the dose descriptor value in units mg/kg bw/day. The bodyweight of 70 kg is the standard value for a human worker as given in Table R.8-18 ofthe ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health.
The UL of 25 mg/d (0.35 mg/kg bw/d) is used as the starting point. As this UL is based on human studies with supplement use (oral exposure), route to route extrapolation is employed for DNEL derivation after dermal exposure. The UL is equivalent to oral NAEL.
It is assumed that dermal absorption of Pyridoxine HCl is at worst similar to oral bioavailability. Therefore, no additional correction factor is required to account for absorption differences.
The conversion of the UL value based on long-term oral exposure (considered to be 24hr/day) for worker exposure (in the case of 8 hour exposure/day) was carried out using modified Haber's law (see below).
Corrected UL worker (C1) = C2 x (t2/t1)
Corrected UL worker = 0.35 mg/kg bw/day / (24h/8h) = 1.05 mg/kg bw/day
where:
C2 = oral UL
t1 = exposure time worker dermal
t2 = exposure time general population oral
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.8 mg/m³
- Most sensitive endpoint:
- neurotoxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: The ECHA REACH Guidance has been used to adapt the European Food Safety Authority's (EFSA) established tolerable upper intake level for humans (SCF, 2000).
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- other: Tolerable Upper Intake Level (UL)
- Value:
- 0.35 mg/kg bw/day
- Modified dose descriptor starting point:
- other: Corrected NAEC general population
- Value:
- 2.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The UL value derived by EFSA is 25 mg/d for an adult (SCF, 2000). This was divided by a bodyweight of 70 kg to give the dose descriptor value in units mg/kg bw/day. The bodyweight of 70 kg is the standard value for a human worker as given in Table R.8-18 ofthe ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health.
The UL of 25 mg/d (0.35 mg/kg bw/d) is used as the starting point. As this UL is based on human studies with supplement use (oral exposure), route to route extrapolation is employed for DNEL derivation after inhalation exposure. The UL is equivalent to oral NAEL.
According the ECHA Guidance Chapter R.8, Example R.8-1, the NAEL (No Adverse Effect Level) human has to be divided by 6.7 m3/person to get the NAEC (No Adverse Effect Concentration) (8 h). It is not expected that the general population would be exposed to the substance for a period of more than 8 hours/day.
6.7 m3 is the respiratory volume for the general public (8 h exposure).
It is assumed that inhalation absorption of Pyridoxine HCl is at worst 100%, whereas oral bioavailability has been shown to be around 75%. Therefore an additional factor of 0.75 is used for correction.
The corrected dose descriptor (NAEC worker) for inhalation was calculated in accordance with the ECHA Guidance mentioned above.
NAEC general population = oral NAEL x (ABSoral/ ABSinh) x (1 / sRV)
NAEC general population = 25 mg/d x (0.75/1) / 6.7 m3/day = 2.8 mg/m3
Where:
ABS: Absorption
sRV: general public Respiratory Volume (8 h)
Default parameters:
sRV (24 h): 6.7 m3/ person
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.35 mg/kg bw/day
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.35 mg/kg bw/day
- Most sensitive endpoint:
- neurotoxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: The European Food Safety Authority (EFSA) have established a tolerable upper intake level for humans (SCF, 2000), most recently confirmed in 2016. This is considered to be equivalent to the Derived No Effect Level.
- Dose descriptor starting point:
- other: Tolerable Upper Intake Level (UL)
- Value:
- 0.35 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The UL value derived by EFSA is 25 mg/d oral intake for an adult (SCF, 2000). This was divided by a bodyweight of 70kg to give the dose descriptor value in units mg/kg bw/day. The bodyweight of 70kg is the standard value as given in Table R.8-18 ofthe ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
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