Registration Dossier
Registration Dossier
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EC number: 913-888-8 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.1 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):
- 72
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 441 mg/m³
- Explanation for the modification of the dose descriptor starting point:
See discussion below
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 34.7 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):
- 72
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
See discussion below
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Starting point: NOAEL 250 mg/kg bw/day from a subacute oral study in rats.
Route-to-route extrapolation
For the derivation of the DNELs:
Long-term – dermal, systemic effects
Long-term – inhalation, systemic effects
Route-to-route extrapolation has been performed. In absence of relevant data, only differences between the different routes as determined by the assumed percentages of absorption into the systemic circulation could be accounted for (see toxicokinetic assessment).
Absorption oral (rat) = Absorption oral (human) = 100%
Absorption dermal (human) = 10%
Absorption inhalation (human) = 100% (Even if inhalation exposure to the two types of reaction mass is not expected, a conservative value has been chosen)
The DNELs for human exposure are derived according to the ECETOC guidance (final draft).
Dermal DNEL
Route-to-route extrapolation:
Dermal NOAEL = oral NOAEL * ABSoral-rat/ABSderm-human = 250 * 100/10 = 2500 mg/kg bw
Safety factors:
- Interspecies extrapolation: 4
- Intraspecies extrapolation: 3
- Exposure duration: 6 (assuming chronic worker exposure)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 72
Based on the above, the long-term DNEL for systemic effects after dermal worker exposure is set at 34.7 mg/kg bw/day.
Inhalation DNEL
Route-to-route extrapolation:
Inhalation NOAEL = oral NOAEL * ABSoral-rat/ABSinh-human = 250 * 100/100 = 250 mg/kg bw
Corrected inhalatory NOAEC = 250 * 1/0.38 * 6.7 m3/10 m3= 441 mg/m3
Safety factors:
- Interspecies extrapolation: 4
- Intraspecies extrapolation: 3
- Exposure duration: 6 (assuming chronic worker exposure)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 72
Based on the above, the long-term DNEL for systemic effects after inhalation exposure of the worker, is set at 6.1 mg/m3.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC Guidance (final draft)
- Overall assessment factor (AF):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 217 mg/m³
- Explanation for the modification of the dose descriptor starting point:
See discussion below
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20.8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC guidance (final draft)
- Overall assessment factor (AF):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
See discussion below
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC guidance (final draft)
- Overall assessment factor (AF):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
See discussion below
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
Starting point: NOAEL 250 mg/kg bw/day from a subacute oral study in rats.
Route-to-route extrapolation
For the derivation of the DNELs:
Long-term – dermal, systemic effects
Long-term – inhalation, systemic effects
Route-to-route extrapolation has been performed. In absence of relevant data, only differences between the different routes as determined by the assumed percentages of absorption into the systemic circulation could be accounted for (see toxicokinetic assessment).
Absorption oral (rat) = Absorption oral (human) = 100%
Absorption dermal (human) = 10%
Absorption inhalation (human) = 100% (Even if inhalation exposure to the two types of reaction mass is not expected, a conservative value has been chosen)
The DNELs for human exposure are derived according to the ECETOC guidance (final draft).
Oral DNEL
Safety factors:
- Interspecies extrapolation: 4
- Intraspecies extrapolation: 5
- Exposure duration: 6 (assuming chronic exposure of the general population)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 120
Based on the above, the long-term DNEL for systemic effects after oral exposure of the general population, is set at 2.1 mg/kg bw/day.
Dermal DNEL
Route-to-route extrapolation:
Dermal NOAEL = oral NOAEL * ABSoral-rat/ABSderm-human = 250 * 100/10 = 2500 mg/kg bw
Safety factors:
- Interspecies extrapolation: 4
- Intraspecies extrapolation: 5
- Exposure duration: 6 (assuming chronic exposure of the general population)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 120
Based on the above, the long-term DNEL for systemic effects after dermal exposure of the general population is set at 20.8 mg/kg bw/day.
Inhalation DNEL
Route-to-route extrapolation:
Inhalation NOAEL = oral NOAEL * ABSoral-rat/ABSinh-human = 250 * 100/100 = 250 mg/kg bw
Corrected inhalatory NOAEC = 250 * 1/1.15 = 217 mg/m3
Safety factors:
- Interspecies extrapolation: 4
- Intraspecies extrapolation: 5
- Exposure duration: 6 (assuming chronic exposure of the general population)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 120
Based on the above, the long-term DNEL for systemic effects after inhalation exposure of the general population is set at 1.8 mg/m3.
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