Registration Dossier
Registration Dossier
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EC number: 200-662-2 | CAS number: 67-64-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 210 mg/m³
DNEL related information
- Modified dose descriptor starting point:
- NOAEC
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:
- DNEL (Derived No Effect Level)
- Value:
- 2 420 mg/m³
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 186 mg/kg bw/day
DNEL related information
- Modified dose descriptor starting point:
- NOAEL
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:
- medium hazard (no threshold derived)
Additional information - workers
Worker-DNEL long-term for dermal route-systemic
Relevant dose-descriptor for the endpoint concerned:OEL of 1210 mg/m3 (SCOEL/SUM/74, 1997; German MAK documentation Acetone, 1993)
Correction of starting point:
Route of exposure (inhalation versus dermal exposure): OEL of 1210 mg/m3 is converted to 1210 mg/person/day assuming a breathing volume of 10 m3 in workers.
Similar exposure conditions (occupational exposure during 8 h shift).
Average person weight of 65 kg
1210mg/m3 x 10 m3/d /65 kg= 186 mg/kg bw/d
Assessment factors relating to the extrapolation procedure:
Assessment factors have been included in derivation of OEL, therefore no further assessment factor
Overall assessment factor: 0
DNEL worker long-term dermal systemic = 186 mg/kg bw/day
Worker-DNEL long-term for inhalation route-systemic
Relevant dose-descriptor for the endpoint concerned: At 1000 ppm marked irritation and ratings of well being and weak reversible reaction at 500 ppm in some but not in all people leads to the consideration that 500 ppm (1210 mg/m3) is appropriate (MAK documentation, 1993).
Assessment factors relating to the extrapolation procedure:
No assessment factor was applied as human data were available.
DNEL worker long-term inhalation systemic = 1210 mg/m3 (500 ppm)
Worker-DNEL acute for inhalation route-local
According to MAK, Peak limitation category I (Substances for which local irritant effects determine the MAK value, also respiratory allergens, Excursion factor 2; Duration 15 min, average value, Number per shift 4, Interval 1h)
DNEL worker acute inhalation local: 2420 mg/m3 (1000 ppm)
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 200 mg/m³
DNEL related information
- Overall assessment factor (AF):
- 5
- Modified dose descriptor starting point:
- NOAEC
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:
- 62 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEL
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:
- 62 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 2
- Modified dose descriptor starting point:
- NOAEL
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:
- medium hazard (no threshold derived)
Additional information - General Population
General population -DNEL long-term for dermal route-systemic
Relevant dose-descriptor for the endpoint concerned:OEL of 1210 mg/m3 (SCOEL/SUM/74, 1997; German MAK documentation Acetone, 1993)
Correction of starting point:
Route of exposure (inhalation versus dermal exposure): the OEL of 1210 mg/m³ is converted to 24200 mg/person/day assuming a breathing volume of 20 m3 in general population
Exposure conditions (occupational exposure versus continuous exposure): daily exposure: workers: 8 h/d; general population: 24 h/d = factor 0.33
Average person weight of 65 kg
1210 mg/m3 x 20 m3/d x 0.33 /65 kg= 123 mg/kg bw/d
Assessment factors relating to the extrapolation procedure:
Interspecies differences: not necessary as OEL was starting point and is based on human data.
Intraspecies differences: assessment factor of 2 due to differences between worker and general population
Overall assessment factor: 2
DNEL general population chronic dermal systemic: 62 mg/kg bw/day
General population -DNEL long-term for inhalation route-systemic
Relevant dose-descriptor for the endpoint concerned:OEL of 1210 mg/m3 (SCOEL/SUM/74, 1997; German MAK documentation Acetone, 1993)
Correction of starting point:
Same route of exposure.
Exposure conditions (occupational exposure versus continuous exposure): daily exposure: workers: 8 h/d; general population: 24 h/d = factor 0.33.
1210 mg/m3 x 0.33 = 400 mg/m3
Assessment factors relating to the extrapolation procedure:
Interspecies differences: not necessary as OEL was starting point and is based on human data.
Intraspecies differences: assessment factor of 2 due to differences between worker and general population
Overall assessment factor: 2
DNEL general population long-term inhalation systemic = 200 mg/m3
General population-DNEL long-term for oral route-systemic
Relevant dose-descriptor for the endpoint concerned:OEL of 1210 mg/m3 (SCOEL/SUM/74, 1997; German MAK documentation Acetone, 1993)
Correction of starting point:
Route of exposure (inhalation versus oral exposure): the OEL of 1210 mg/m3 is converted to 24200 mg/person/day assuming a breathing volume of 20 m3 in general population;
Exposure conditions (occupational exposure versus continuous exposure): Daily exposure: workers: 8 h/d; general population: 24 h/d = factor 0.33.
Average person weight of 65 kg
1210 mg/m3 x 20 m3/d x 0.33 /65 kg= 123 mg/kg bw/d
Assessment factors relating to the extrapolation procedure:
Interspecies differences: not necessary as OEL was starting point and is based on human data.
Intraspecies differences: assessment factor of 2 due to differences between worker and general population
Overall assessment factor: 2
DNEL general population long-term oral systemic: 62 mg/kg bw/day
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