Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
600 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other:
Modified dose descriptor starting point:
other:
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:
405 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEL
Value:
20 250 mg/kg bw/day
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

Acute DNELs - Worker: Production of SBA is in excess of 10 t/y. According to the REACh "Guidance on information requirements and chemical safety assessment, Part B: Hazard Assessment", above 10 t/y, the establishment of acute toxicity DNEL is unnecessary in most cases, as the DNEL based on repeated dose toxicity is normally sufficient to ensure that adverse effects do not occur. Thus, as long term DNELs are available for SBA, separate acute DNELs were not derived. Assessment of acute effects should default to the long term systemic DNELs. Local Effects - not classified as a skin irritant - local effects not quantifiable

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
213 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other:
Modified dose descriptor starting point:
other:
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:
203 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
20 300 mg/kg bw/day
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
15 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
other: NOEL
Value:
1 500 mg/kg bw/day
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

Discussion: Similar to worker, acute effects for general populations should default to long-term systemic DNELs. Local effects not quantifiable; SBA is not a skin irritant. DNELs are based on study entitled: "Toxicity Studies in Rats with 2-Butanol Including Growth, Reproduction, and Teratologic Observations "HSE-75-0070 US EPA 2003 HSE-75-0070", which is a two generation rat study. With respect to most sensitive endpoint; although the study was for teratogenicity; the chemical was not found to be a teratogen or developmental toxicant; thus the most senstive endpoint was selected as repeated dose toxicity. Starting Dose for DNEL Calculation (NOEL) = 1% or ~1500 mg/kg/d. The modified doses for DNEL Calculations = Inhalation worker: 2645 mg/m3; Inhalation general population: 1304 mg/m3; Dermal worker: 1500 mg/kg bw; Dermal general population: 1500 mg/kg/d; Oral general population = 1500 mg/kg/d. In the absence of quantitative absorption data for SBA, data available for the related compound MEK were used for the purpose of calculating an inhalation and dermal DNEL from the oral SBA study: Inhalation: Ibriani et al., 1989 reported 54% retention from inhalation exposures to MEK; Oral: MEK and SBA have a molecular weight of <500 g/mol and a log Kow between 0 and 4; therefore, it is assumed to be well absorbed equivalently by the oral and inhalation route; therefore, oral assumed to be 54%. Dermal: dermal absorption of MEK, in vivo, was reported to be 4%. (NIOSH, 2002) References for MEK absorption data: Imbriani M, Ghittori S, Pezzagno G, Capodaglio E. Methyl ethyl ketone (MEK) in urine as biological index of exposure. G Ital Med Lav. 1989 Nov;11(6):255-61. NIOSH. Dermal Absorption of Vapours: Comparison of In Vivo and In Vitro Data. Proceedings of the International Conference on Occupational & Environmental Exposures of Skin to Chemicals: Science & Policy, Hilton Crystal City, September 8-11, 2002.