Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
