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EC number: 200-661-7
CAS number: 67-63-0
Worker: Production of IPA 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 IPA and
IPA is not classified for acute toxicity via any route of exposure,
separate acute DNELs were not derived. Since
there are only few and partially only conditionally convincing results
concerning the irritant effect of 2-propanol in man and animal, any
irritant effect is considered unlikely at this concentration.
There is no IOEL value for IPA. A German MAK was available and
deemed suitable for derivation of the DNEL.
Reference: Deutsche Forschungsgemeinschaft List of MAK and BAT
Values 2007 Commission for the Investigation of Health Hazards of
Chemical Compounds in the Work Area Report No. 43
In animal experiments testing subchronic exposures of at least 500
ml/m³ nasal incrustations were observed in male rats. Since there were
no microscopic changes, the toxicological relevance of these results is
doubtful. The renal changes also observed in male rats exposed to these
concentrations are species- and sex-specific effects. When exposing the
animals to 1,500 ml/m³ of 2-propanol, only female mice presented a
higher relative liver weight. After chronic exposure of male rats to at
least 500 ml/m³, the testicle weights and interstitial cytoadenomas of
the testicles were found to be slightly increased. In mice inhaling
these concentrations the relative testicle weights were reduced, whereas
the absolute and relative liver weights were increased. However, this
did not always apply to both sexes. The histological results of these
organs were not contributory. For the present, it is difficult to state
the human relevance of the partially minimal or sex-specific findings in
rats and mice exposed to 500 ml/m³.
'MAK Values and Pregnancy' (examinations on rats, 1989): that
inhalation of 400 ml/m³ of 2-propanol presumably does not have any
embryotoxic effect has been confirmed by further examinations on another
The MAK value of 2-propanol is provisionally lowered to 200 ml/m³
(=500 mg/m3). Since there are only few and partially only
conditionally convincing results concerning the irritant effect of
2-propanol in man and animal, any irritant effect is considered unlikely
at this concentration.
Starting Dose for DNEL calculation:
500 mg/m3(based on occupational exposure of 8
hours/day, 5 days/week)
Modified dose for DNEL Calculation
Worker – Inhalation = 500 mg/m3(no adjustment
Worker – Dermal =500 mg/m3x 10 m3/d/70
kg = 71 mg/kg/d; 71 mg/kg/d x 100%/8% (Absorption correction – see
absorption data below) = 888 mg/kg/d
Assessment Factors– no adjustments required
for interspecies, exposure duration, dose response or quality of whole
database as DNEL is based on an occupational limit for workers.
Final DNELs = Modified Dose; Worker – Inhalation DNEL = 500 mg/m3;
Worker – Dermal DNEL =888 mg/kg/d
Oral: Oral absorption is nearly 100% as evidenced by the nearly
complete lack of radiolabel in feces for up to 168 hours following
gavage administration of radiolabeled IPA (see toxicokinetic statement)
Inhalation: IPA has 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, inhalation
absorption assumed to be 100%.
Dermal: Dermal absorption of IPA is rapid but limited. Following a
4-hour occlusive application 84 to 86% of the applied dose was recovered
from the skin and 8 to 9% was lost (presumably to volatilization); thus,
approximately 5 to 8% of the applied dose was absorbed systemically (see
toxicokinetic statement). For the purpose of the DNEL calculation,
dermal absorption was conservatively assumed to be 8%.
Acute DNELs - General Population: Similar to
above for worker, assessment of acute systemic effects should default to
the long term systemic DNELs; IPA not classified as a skin irritant;
default to systemic DNEL for inhalation local effects.
The long-term DNEL for the general population was derived from the
500 mg/m3(based on occupational exposure of 8
hours/day, 5 days/week) (amortized below for continuous exposure)
General Population – Inhalation = 500 mg/m3x10/6.7x
8/24 x 5/7 (amortized for continuous exposure) = 178 mg/m3
General Population – Oral =178 mg/m3x 20 m3/d/70
kg = 51 mg/kg/d (no adjustment for absorption)
General Population - Dermal =178 mg/m3x 20 m3/d/70
kg = 51 mg/kg/d; 51 mg/kg/d x 100%/8% (Absorption correction – see above
under worker) = 638 mg/kg/d
Assessment Factors (AF)–
No adjustments required for interspecies, exposure duration, dose
response or quality of whole database as DNEL is based on an
occupational limit for workers.
An AF of 2 applied for differences between workers and general
population (basis: when extrapolating from animal to human, the
recommended AF is 10 for general population and 5 for worker – since the
starting dose is amortized for continuous exposure an additional 2 fold
AF for differences was considered sufficient)
Final DNELs = Modified Dose; General population – Dermal DNEL =
638mg/kg/d/2 = 319 mg/kg/d;General population – Inhalation DNEL178 mg/m3/2
= 89 mg/m3; General population – Oral DNEL = 51mg/kg/d/2 = 26
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