Registration Dossier
Registration Dossier
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EC number: 265-450-4 | CAS number: 65113-95-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 92.75 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 37.5
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 13.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
The dermal DNEL for long term exposure was based on the 28 -Day dermal study in which a NOAEL of 2000 mg/kg/day was established. In accordance with the guidelines, the following assessment factors used were: Rat (4), remaining differences (2.5), workers (5), exposure duration (3), dose response (1), quality (1).
The inhalation DNEL for long term exposure (systemic effects) was based on the oral 28-Day study, in which a NOAEL of 1000mg/kg/day was established. The assessment factors were: Rat (4), remaining differences (2.5), workers (5), exposure duration (3), dose response (1), quality (1).
As no acute effects were recorded and no classification and labelling is necessary, no acute DNEL is derived in accordance with the guidance. It is assumed that the long term DNEL is sufficient to ensure acute effects do not occur. Furthermore, no DNELs for local effects have been derived as no local effects were observed.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 23.15 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.67 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
The dermal DNEL for long term exposure (systemic effects) was based on the dermal 28-Day study, in which a NOAEL of 2000mg/kg/day was established. The assessment factors were: Rat (4), remaining differences (2.5), workers (5), exposure duration (3), dose response (1), quality (1).
The inhalation DNEL for long term exposure (systemic effects) was based on the oral 28-Day study, in which a NOAEL of 1000mg/kg/day was established. The assessment factors were: Rat (4), remaining differences (2.5), workers (5), exposure duration (3), dose response (1), quality (1).
The oral DNEL for long term exposure (systemic effects) was based on the oral 28-Day study, in which a NOAEL of 1000mg/kg/day was established. The assessment factors were: Rat (4), remaining differences (2.5), workers (5), exposure duration (3), dose response (1), quality (1).
The oral DNEL for long term exposure (systemic effects) was based on the oral 28-Day study, in which a NOAEL of 1000mg/kg/day was established. The assessment factors were: Rat (4), remaining differences (2.5), workers (5), exposure duration (3), dose response (1), quality (1).
Ebanol is considered a suitable substance to read-across to MTCP Crude and so these data are considered suitable to be used for the calculation of DNELs for this substance.
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.
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