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Registration Dossier
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EC number: 920-031-1 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 13.9 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
Workers - Hazard for the eyes
Additional information - workers
Route-to-route extrapolation
Based on the Toxicokinetic assessment report on Biomass Residue (liquid) obtained after B2 production (see endpoint 7.1.1), the following values are considered for absorption:
Oral absorption: 50%
Dermal absorption: 50%
Inhalation absorption: 100%
The DNELs for human exposure are derived according to the ECETOC guidance (final draft March 26, 2010).
Biomass Residue (liquid) obtained after B2 production is not classified for acute oral and dermal effects, and therefore no acute DNELs are derived. The long-term systemic DNEL is considered sufficient to ensure that effects from acute exposure do not occur (Chapter R.8 from ECHA Guidance on information requirements and chemical safety assessment).
In addition, local DNELs need not to be derived as the substance does not show local effects in the available studies.
The following DNELs for workers are considered:
Systemic:
Long term dermal
Long term inhalation
All DNELs are external values.
Systemic effects ¿ long term
Dermal
Starting point: NOAEL of = 1000 mg/kg bw/day in a combined 28-day repeated dose oral toxicity study with the reproduction/developmental toxicity screening test in rats.
Correction dermal NOAEL: 1000 x 50/50a=1000 mg/kg bw/day
a: oral/dermal absorption
Safety factors:
- Interspecies extrapolation: 4 (rat to human)
- Intraspecies extrapolation: 3
- Exposure duration: 6 (assuming chronic exposure of the worker)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 72
Based on the above, the long-term DNEL for systemic effects after oral exposure of the general population is set at 13.9 mg/kg bw/day.
Inhalation
Starting point: NOAEL of = 1000 mg/kg bw/day in a combined 28-day repeated dose oral toxicity study with the reproduction/developmental toxicity screening test in rats.
Conversion of an oral rat NOAEL into a corrected NOAEC:
For workers (8h exposure/day), the corrected inhalatory NOAEC = oral NOAEL * 1/sRVrat * ABSoral-rat/ABSinhal-human* sRVhuman/wRV
= oral NOAEL * 1/0.38 m3/kg/8h * ABSoral-rat/ABSinhal-human* 6.7 m3(8h)/10 m3(8h)
= oral NOAEL * 1/0.38 m3/kg/8h * 50/100 * 6.7 m3(8h)/10 m3(8h)
= 1000 /0.38 * (1/2) * (6.7/10) = 882 mg/m3.
With ABS: Absorption, sRV: Standard Respiratory Volume; wRV: Worker Respiratory Volume;
ABSoral-rat/ABSinhal-human= 50/100, assuming no differences in inhalation absorption between rats and humans.
Safety factors:
- Interspecies extrapolation: 4 (rat to human)
- Intraspecies extrapolation: 3
- Exposure duration: 6 (assuming chronic exposure of the worker)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 72
Based on the above, the long-term DNEL for systemic effects after inhalation exposure of the worker is set at 12.2 mg/m3.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.62 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Route-to-route extrapolation
Based on the Toxicokinetic assessment report on Biomass Residue (liquid) obtained after B2 production (see endpoint 7.1.1), the following values are considered for absorption:
Oral absorption: 50%
Dermal absorption: 50%
Inhalation absorption: 100%
The DNELs for human exposure are derived according to the ECETOC guidance (final draft March 26, 2010).
Biomass Residue (liquid) obtained after B2 production is not classified for acute oral and dermal effects, and therefore no acute DNELs are derived. The long-term systemic DNEL is considered sufficient to ensure that effects from acute exposure do not occur (Chapter R.8 from ECHA Guidance on information requirements and chemical safety assessment).
In addition, local DNELs need not to be derived as the substance does not show local effects in the available studies.
The following DNELs for the general population are considered:
Systemic:
Long term oral
Long term dermal
Long term inhalation
All DNELs are external values.
Systemic effects ¿ long term
Oral
Starting point: NOAEL of = 1000 mg/kg bw/day in a combined 28-day repeated dose oral toxicity study with the reproduction/developmental toxicity screening test in rats.
Safety factors:
- Interspecies extrapolation: 4 (rat to human)
- Intraspecies extrapolation: 5
- Exposure duration: 6 (assuming chronic exposure of the general population)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 120
Based on the above, the long-term DNEL for systemic effects after oral exposure of the general population is set at 8.3 mg/kg bw/day.
Dermal
Starting point: NOAEL of = 1000 mg/kg bw/day in a combined 28-day repeated dose oral toxicity study with the reproduction/developmental toxicity screening test in rats.
Correction dermal NOAEL: 1000 x 50/50a=1000 mg/kg bw/day
a: oral/dermal absorption
Safety factors:
- Interspecies extrapolation: 4 (rat to human)
- Intraspecies extrapolation: 5
- Exposure duration: 6 (assuming chronic exposure of the worker)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 120
Based on the above, the long-term DNEL for systemic effects after oral exposure of the general population is set at 8.3 mg/kg bw/day.
Inhalation
Starting point: NOAEL of = 1000 mg/kg bw/day in a combined 28-day repeated dose oral toxicity study with the reproduction/developmental toxicity screening test in rats.
Conversion of an oral rat NOAEL into a corrected NOAEC:
For the general population (24h exposure/day), the corrected inhalatory NOAEC = oral NOAEL * 1/sRVrat * ABSoral-rat/ABSinhal-human* sRVhuman/wRV
= oral NOAEL * 1/1.15 m3/kg/d * ABSoral-rat/ABSinhal-human
= 1000 /1.15 * (50/100) = 435 mg/m3.
With ABS: Absorption, sRV: Standard Respiratory Volume; wRV: Worker Respiratory Volume;
ABSoral-rat/ABSinhal-human= 50/100, assuming no differences in inhalation absorption between rats and humans.
Safety factors:
- Interspecies extrapolation: 4 (rat to human)
- Intraspecies extrapolation: 5
- Exposure duration: 6 (assuming chronic exposure of the worker)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 120
Based on the above, the long-term DNEL for systemic effects after inhalation exposure of the worker is set at 3.62 mg/m3.
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