Registration Dossier
Registration Dossier
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EC number: 268-610-1 | CAS number: 68131-13-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 51.3 µg/m³
DNEL related information
- Overall assessment factor (AF):
- 180
- Modified dose descriptor starting point:
- LOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 102.6 µg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 180
- Modified dose descriptor starting point:
- LOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 51.3 µg/m³
DNEL related information
- Overall assessment factor (AF):
- 180
- Dose descriptor:
- LOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 51.3 µg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 180
- Dose descriptor starting point:
- LOAEC
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 583 µg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 180
- Modified dose descriptor starting point:
- LOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 166 µg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 180
- Modified dose descriptor starting point:
- LOAEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 266 µg/cm²
DNEL related information
- Overall assessment factor (AF):
- 180
- Dose descriptor:
- other: LOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 266 µg/cm²
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 180
- Dose descriptor starting point:
- other: LOAEL
Workers - Hazard for the eyes
Additional information - workers
All the DNELs values were derived starting from the OECD 422 combined repro study in rodent where a LOAEL of 100 mg/kg/day was determined by oral administration of the substance at fixed doses of 100, 300 and 750 mg/kg/day with the exception of the NAEL dermal that was derived form the acute dermal study where a NOAEL could be determined on the basis of the study results. Inhalation and dermal systemic DNELs were calculated adopting a route to route extrapolation assessment considering differences in the absorption rate by oral rat and inhalation humans.
Concerning the DNELdermal local we considered as starting point the calculation done on the basis of the data from the dermal acute study by skin application as the worst case approach.
DNELacute where also calculated in order to evaluate possible peak exposures (short exposure of 15 minutes) in particular for inhalation and dermal effects where. A factor of2was applied to the NOAELoral and deemed enough conservative.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 127 µg/m³
DNEL related information
- Overall assessment factor (AF):
- 360
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 254 µg/m³
DNEL related information
- Overall assessment factor (AF):
- 360
- Modified dose descriptor starting point:
- LOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 127 µg/m³
DNEL related information
- Overall assessment factor (AF):
- 360
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 127 µg/m³
DNEL related information
- Overall assessment factor (AF):
- 360
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 292 µg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 360
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 584 µg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 360
- Modified dose descriptor starting point:
- LOAEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 133 µg/cm²
DNEL related information
- Overall assessment factor (AF):
- 360
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 133 µg/cm²
DNEL related information
- Overall assessment factor (AF):
- 360
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 292 µg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 360
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 584 µg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 360
- Modified dose descriptor starting point:
- LOAEL
General Population - Hazard for the eyes
Additional information - General Population
All the DNELs values were derived starting from the OECD 422 combined repro study in rodent where a LOAEL of 100 mg/kg/day was determined by oral administration of the substance at fixed doses of 100, 300 and 750 mg/kg/day with the exception of the NAEL dermal that was derived form the acute dermal study where a NOAEL could be determined on the basis of the study results. Inhalation and dermal systemic DNELs were calculated adopting a route to route extrapolation assessment considering differences in the absorption rate by oral rat and inhalation humans.
Concerning the DNELdermal local we considered as starting point the calculation done on the basis of the data from the dermal acute study by skin application as the worst case approach.
DNELacute where also calculated in order to evaluate possible peak exposures (short exposure of 15 minutes) in particular for inhalation and dermal effects where. A factor of2was applied to the NOAELoral and deemed enough conservative.
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.
