Registration Dossier
Registration Dossier
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EC number: 203-378-7 | CAS number: 106-25-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 374 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 330 mg/m³
- Explanation for the modification of the dose descriptor starting point:
In the absence of data on absorption, it was assumed that 50% absorption occurs by the oral route.
To secure a conservative external NOAEL a maximum absorption should be assumed for the inhalation route (i.e.; 100%).
To convert the oral NOAEL into inhalatory NOAEC, a rat default respiratory volume was used corresponding to the daily duration of human exposure (sRVrat: 0.38 m3/kg bw/8h).
For workers a correction was added for the difference between respiratory rates under standard conditions (sRVhuman: 6.7 m3 for an 8h exposure period) and under conditions of light activity (wRV: 10 m3 for an 8h exposure period).
Thus, the corrected starting point for inhalation is: 374 mg/kg bw/d x (1/0.38 m3/kg bw/8h) x (6.7 m3 for 8h exposure /10 m3 for 8h exposure) / 2 = 330 mg/m3 for workers.
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- Sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for oral to inhalation extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- Toxicodynamic and toxicokinetic remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate database
- AF for remaining uncertainties:
- 1
- Justification:
- None
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
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 374 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 374 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No additional factor is needed when performing oral to dermal extrapolation.
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Toxicodynamic and toxicokinetic remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate database
- AF for remaining uncertainties:
- 1
- Justification:
- None
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium 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:
- 1.09 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 374 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 163 mg/m³
- Explanation for the modification of the dose descriptor starting point:
In the absence of data on absorption, it was assumed that 50% absorption occurs by the oral route.
To secure a conservative external NOAEL a maximum absorption should be assumed for the inhalation route (i.e.; 100%). To convert the oral NOAEL into inhalatory NOAEC, a rat default respiratory volume was used corresponding to the daily duration of human exposure (sRVrat: 1.15 m3/kg bw/d). Thus, the corrected starting point for inhalation is : 374 mg/kg bw/d x (1/1.15 m3/kg bw/d) / 2 = 163 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- Sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for oral to inhalation route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- Toxicodynamic and toxicokinetic remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate database
- AF for remaining uncertainties:
- 1
- Justification:
- None
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
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.62 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 374 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 374 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No additional factor is needed when performing oral to dermal extrapolation
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Toxicodynamic and toxicokinetic remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate database
- AF for remaining uncertainties:
- 1
- Justification:
- None
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:
- 0.62 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 374 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 374 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route-to-route extrapolation needed.
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Toxicodynamic and toxicokinetic remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate database
- AF for remaining uncertainties:
- 1
- Justification:
- None
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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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