Registration Dossier
Registration Dossier
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EC number: 202-488-2 | CAS number: 96-20-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 9
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.31 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 36
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Acute DNELs for local and systemic effects are not considered appropriate. 2 -Aminobutanol is corrosive and therefore acute exposures will be limited by the precautions in place to prevent corrosion.
Starting point for DNEL derivation
For Long term exposure, systemic inhalation and dermal DNELS are calculated using the NOEL of 7.1 mg/kg bw/day from the OECD 422 study as the starting point.
Assessment factors:
Allometric scaling - 4 (only for dermal DNEL)
'Other Differences' - 1 -Based on what is known about the structural analogue AMP, it is not considered likely that other factors than allometric scaling will drive the difference in sensitivity of man compared to rats.
Duration Factor - 3 - Extrapolation from a sub-acute study to a chronic DNEL based on the factors proposed by ECETOC and Batke et al, 2010)
Worker variability - 3 - based on the factors proposed by ECETOC
Severity of effect - 1 - even though the effect driving the NOEL is reproductive toxicity (post - implantation loss), read across to the structural analogue AMP indicates that this is a thresholded mechanism and that increasing duration should not result in the NOEL dropping, nor an increase in the severity of the effect.
Sensitivity of test - 1 - It is considered highly plausible that the mechanism by which aminobutnaol causes toxicity is the same as that seen with AMP. Therefore even though the OECD 422 from which the NOEL is taken is not as sensitive as a 1 or 2 generation study, the data available for AMP indicate that doing such a study would be unlikely to change the NOEL or the types of toxicity observed.
Overall assessment factor (Inhalation) = 9
Overall assessment factor (Dermal) = 36
Worker Inhalation DNEL (systemic effects)
Starting point: 7.1 mg/kg bw (rat NOEL)
Conversion of oral NOEL to human inhalatory NOEL
= 7.1 / 0.38 * 6.7/10
= 12.5 mg/m3
Application of Assessment factor = 12.5/9
DNEL = 1.4 mg/m3
Worker Dermal DNEL (systemic)
Percentage of an applied dose penetrating the skin estimated to be 15% (refer to toxicokinetics section) Oral bioavailability estimated to be 100%
Conversion of Oral NOEL to human Dermal NOEL
= 7.1 * (1/0.15)
= 47.3 mg/kg bw/day
Application of assessment factor = 47.3/36
DNEL = 1.3 mg/kg bw/day
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.34 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.66 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
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.1 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
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Acute DNELs for local and systemic effects are not considered appropriate. 2 -Aminobutanol is corrosive and therefore acute exposures will be limited by the precautions in place to prevent corrosion.
Starting point for DNEL derivation
For Long term exposure, systemic inhalation and dermal DNELS are calculated using the NOEL of 7.1 mg/kg bw/day from the OECD 422 study as the starting point.
Assessment factors:
Allometric scaling - 4 (only for dermal DNEL)
'Other Differences' - 1 -Based on what is known about the structural analogue AMP, it is not considered likely that other factors than allometric scaling will drive the difference in sensitivity of man compared to rats.
Duration Factor - 3 - Extrapolation from a sub-acute study to a chronic DNEL based on the factors proposed by ECETOC and Batke et al, 2010)
General Population variability - 6 - based on the factors proposed by ECETOC
Severity of effect - 1 - even though the effect driving the NOEL is reproductive toxicity (post - implantation loss), read across to the structural analogue AMP indicates that this is a thresholded mechanism and that increasing duration will no result in the NOEL dropping, nor an increase in the severity of the effect.
Sensitivity of test - 1 - It is considered highly plausible that the mechanism by which aminobutnaol causes toxicity is the same as that seen with AMP. Therefore even though the OECD 422 from which the NOEL is taken is not as sensitive as a 1 or 2 generation study, the data available for AMP indicate that doing such a study would be unlikely to change the NOEL or the types of toxicity observed.
Overall assessment factor (Inhalation) = 18
Overall assessment factor (Dermal, and oral) = 72
General Population Inhalation DNEL (systemic effects)
Starting point: 7.1 mg/kg bw (rat NOEL)
Conversion of oral NOEL to human inhalatory NOEL
= 7.1 /1.15
= 6.2 mg/m3
Application of Assessment factor = 6.2/18
DNEL = 0.34 mg/m3
General Population Dermal DNEL (systemic)
Percentage of an applied dose penetrating the skin estimated to be 15% (refer to toxicokinetics section) Oral bioavailability estimated to be 100%
Conversion of Oral NOEL to human Dermal NOEL
= 7.1 * (1/0.15)
= 47.3 mg/kg bw/day
Application of assessment factor = 47.3/72
DNEL = 0.66 mg/kg bw/day
General Population Oral DNEL
Rat Oral NOEL = 7.1 mg/kg bw/day
Human and rat bioavailability considered to be the same
Application of assessment factors = 7.1/72
DNEL = 0.1 mg/kg bw/day
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