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Registration Dossier
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EC number: 261-605-5 | CAS number: 59113-36-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 55 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 6
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 55 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 3
- Dose descriptor:
- NOAEC
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:
- 833 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 12
- Modified dose descriptor starting point:
- NOAEL
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:
- no hazard identified
Additional information - workers
Route-to-route extrapolation
Necessary for the long-term systemic dermal DNEL for the general population and workers.
For both oral and dermal absorption, 100% is assumed based on a toxicokinectic assessment.
Derivation of DNELs
The DNELs for human exposure are derived according to the ECETOC guidance (Technical Report No. 110, October 2010).
Long-term dermal, systemic effects
Worker
Starting point: NOAEL of ≥ 10000 mg/kg bw/day from an oral chronic toxicity study in rats with glycerol.
Corrected dermal NOAEL = 10000 x 100/100 = 10000 mg/kg bw/day
Safety factors:
- Interspecies extrapolation: 4
- Intraspecies extrapolation: 3
- Exposure duration: 1
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 12
Based on the above, the long-term DNEL for systemic effects after dermal worker exposure is set at 833 mg/kg bw/day.
Long-term inhalation, systemic effects
Worker
Starting point: NOAEC of ≥ 662 mg/m3 from a 13 -week inhalation study in rats (exposure 6 hours/day, 5 days/week).
Corrected inhalatory NOAEC = 662 * 6h/8h * 6.7 m3/10 m3= 333 mg/m3.
Safety factors:
- Interspecies extrapolation: 1 (not applicable for inhalation route)
- Intraspecies extrapolation: 3
- Exposure duration: 2 (assuming chronic worker exposure)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 6
Based on the above, the long-term DNEL for systemic effects after inhalation worker exposure is set at 55 mg/m3.
Long-term inhalation, local effects
Worker
Starting point: NOAEC of 165 mg/m3 from a 13-week inhalation study in rats (exposure 6 hours/day, 5 days/week).
Corrected inhalatory NOAEC = 165 mg/m3(no time scaling and no correction for ventilation rate are considered necessary for local effects).
Safety factors:
- Interspecies extrapolation: 1 (not applicable for local effects)
- Intraspecies extrapolation: 3
- Exposure duration: 1 (not applicable for local effects)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 3
Based on the above, the long-term DNEL for local effects after inhalation worker exposure is set at 55 mg/m3.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 33 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- NOAEC
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:
- 500 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEL
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:
- 500 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEL
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
Necessary for the long-term systemic dermal DNEL for the general population and workers.
For both oral and dermal absorption, 100% is assumed based on a toxicokinectic assessment.
Derivation of DNELs
The DNELs for human exposure are derived according to the ECETOC guidance (Technical Report No. 110, October 2010)
Long-term oral, systemic effects
General population
Starting point: NOAEL of ≥ 10000 mg/kg bw/day from an oral chronic toxicity study in rats with glycerol.
Safety factors:
- Interspecies extrapolation: 4
- Intraspecies extrapolation: 5
- Exposure duration: 1 (assuming chronic exposure of the general population)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 20
Based on the above, the long-term DNEL for systemic effects after oral exposure of the general population is set at 500 mg/kg bw/day.
Long-term inhalation, systemic effects
General population
Starting point: NOAEC of ≥ 662 mg/m3 from a 13-week inhalation study in rats (exposure 6 hours/day, 5 days/week) with glycerol.
Corrected inhalatory NOAEC = 662 * 6h/24h * 5/7 = 118 mg/m3
Safety factors:
- Interspecies extrapolation: 1 (not applicable for inhalation route)
- Intraspecies extrapolation: 5
- Exposure duration: 2 (assuming chronic exposure of the general population)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 10
Based on the above, the long-term DNEL for systemic effects after inhalation exposure of the general population is set at 12 mg/m3.
Long-term inhalation, local effects
General population
Starting point: NOAEC of 165 mg/m3 from a 13-week inhalation study in rats (exposure 6 hours/day, 5 days/week) with glycerol.
Corrected inhalatory NOAEC = 165 mg/m3(no time scaling and no correction for ventilation rate are considered necessary for local effects).
Safety factors:
- Interspecies extrapolation: 1 (not applicable local effects)
- Intraspecies extrapolation: 5
- Exposure duration: 1 (not applicable for local effects)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 5
Based on the above, the long-term DNEL for local effects after inhalation exposure of the general population is set at 33 mg/m3.
Long-term dermal, systemic effects
General population
Starting point: NOAEL of ≥ 10000 mg/kg bw/day from an oral chronic toxicity study in rats with glycerol.
Corrected dermal NOAEL = 10000 x 100/100 = 10000 mg/kg bw/day
Safety factors:
- Extrapolation oral to dermal: 1
- Interspecies extrapolation: 4
- Intraspecies extrapolation: 5
- Exposure duration: 1
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 20
Based on the above, the long-term DNEL for systemic effects after dermal exposure of the general population is set at 500 mg/kg bw/day.
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