Registration Dossier
Registration Dossier
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EC number: 203-685-6 | CAS number: 109-59-1
Endpoint summary
Administrative data
Description of key information
ORAL ROUTE:
Rat LD50 values: iPrGE: >2000mg/kg, Klimisch 4 study LD50=5.66mL/kg
INHALATION
Rat: LCLo >160ppm. LC50 values (4hrs) : >3500ppm, (SVP) <4000ppm
Mouse: LC50 (7hrs): 1930ppm (8.2mg/L)
DERMAL
Rabbit LD50: isoproxy ethanol: 1440mg/kg, n-propoxyethanol 1337mg/kg
Key value for chemical safety assessment
Additional information
Two acute oral toxicity studies are available by the oral route in rats using the substance isopropoxyethanol. Whilst one cannot be rated for reliability, both show that the LD50 is above 2000mg/kg. The reliable study is only a limit study. Together they provide information from which it can be concluded with sufficient confidence that the LD50 exceeds 200mg/kgbw.
A number of acute toxicity studies are available by the inhalation route in rats that use the substance isopropoxyethanol. Together they provide a consistent picture. The 4 hour LC50 in rats seems to lie in the region of 3500-4000ppm (15-17.3mg/l). It should be noted that this is around the saturated vapour concentration at 20C of 3750ppm. A single old study is available in mice; this derived an LC50 of 1930ppm (8.3mg/l) but this was from a duration of 7 hours exposure. Using the Haber rule, this would (conservatively) extrapolate to an LC50 of 10mg/L for a 4 hour exposure.
There is an old acute toxicity study available by the dermal route in rabbits using isopropoxyethanol and a well reported study with the isomer n-propoxyethanol. Both report similar LD50s of around 1.3-1.4mg/kgbw. .
Justification for classification or non-classification
ORAL ROUTE: Based on the available data, the LD50 of isopropoxyethanol in rats is clearly above the threshold for classification. Based on the available evidence, classification for acute toxicity by the oral route does not appear warranted.
INHALATION ROUTE: Based on the available data, the LC50 of rats seems to lie in the range 15-17mg/l. The rat is the preferred species for classification. Based on this information, a classification of category 4 by inhalation appears warranted. A single LC50 in mice of 1930ppm (8.4mg/l) is available but this was from a 7hr exposure. This equates to an LC50 of 10mg/L for 4 hours using the Haber rule. Such a result should be given less weighting in terms of reliability but would still fit in with the classification derived from rats. The available data seems to be adequate for classification purposes
DERMAL ROUTE: Based on the available data, an LC50 of around 1.3-1.4mg/kg would suggest a classification of acute category 4 by the dermal route is warranted.
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