Registration Dossier
Registration Dossier
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EC number: 601-490-4 | CAS number: 117704-25-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.07 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1.76 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Kinetics (metabolism, distribution and excretion) are considered to be similar for oral and inhalation intake.
Starting point: NOAEL of 1 mg/kg bw/day in the two generation study in rats.
Conversion of an oral NOAEL into a corrected NOAEC:
For workers (8h exposure/day), the corrected inhalatory NOAEC = oral NOAEL * 1/sRVrat * ABSoralrat/ABSinhal-human * sRVhuman/wRV
= 1 * 1/0.38 m3/kg/8h * 1 * 6.7 m3 (8h)/10 m3(8h)
= 1 /0.38 * 1* (6.7/10) = 1.76 mg/m3.- AF for dose response relationship:
- 1
- Justification:
- NOAEL used
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not apply as already accounted in starting point modification
- AF for other interspecies differences:
- 2.5
- Justification:
- default value in guidance
- AF for intraspecies differences:
- 5
- Justification:
- default value for workers in guidance
- AF for the quality of the whole database:
- 1
- Justification:
- GLP study used
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
assume dermal absorption is 20% of oral
- AF for dose response relationship:
- 1
- Justification:
- NOAEL value used
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default value for rat
- AF for intraspecies differences:
- 5
- Justification:
- default value in ECHA guidance
- AF for the quality of the whole database:
- 1
- Justification:
- GLP study used
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.017 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.87 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Kinetics (metabolism, distribution and excretion) are considered to be similar for oral and inhalation intake.
For the general population (24h exposure/day), the corrected inhalatory NOAEC = oral NOAEC * 1/sRVrat * ABSoral-rat /ABSinhal-human
= 1 * 1/1.15 m3/kg * ABSoral-rat /ABSinhal-human
= 1 * 1/1.15 m3/kg * 1 = 0.87 mg/m3- AF for dose response relationship:
- 1
- Justification:
- NOAEL value used
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not apply as already accounted in starting point modification
- AF for other interspecies differences:
- 2.5
- Justification:
- default value in guidance
- AF for intraspecies differences:
- 10
- Justification:
- default value for general population in guidance
- AF for the quality of the whole database:
- 1
- Justification:
- GLP study used
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.062 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 80
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
assume dermal absorption is 20% of oral
- AF for dose response relationship:
- 1
- Justification:
- NOAEL value used
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default value for rat
- AF for intraspecies differences:
- 10
- Justification:
- default value for general population in guidance
- AF for the quality of the whole database:
- 1
- Justification:
- GLP study used
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.013 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 80
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL value used
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default value for rat
- AF for intraspecies differences:
- 10
- Justification:
- default value for general population in guidance
- AF for the quality of the whole database:
- 1
- Justification:
- GLP study used
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
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