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EC number: 201-158-5
CAS number: 78-92-2
In a read-across study, Fischer 344 rats and CD-1 mice were exposed to 0, 500, 2500 or 5000 ppm (0, 1229, 6145 or 12290 mg/m3) of Isopropanol vapor, 6 hours/day, 5 days/week for 78 weeks (mice) or 104 weeks (rats). No increased incidence of neoplastic lesions were observed in mice and female rats. There was a statistically significant increase in Leydig cell tumors in male rats, a common spontaneous neoplasm in aged rats of this strain. In addition, the authors indicated that this statistically significant increase was most likely due to the unusually low incidence in controls and hence not considered relevant to human risk.
The substance does not meet the criteria for classification and
labelling for this endpoint, as set out in Regulation (EC) NO. 1272/2008.
the absence of a chronic toxicity study for sBA, an existing study on
isopropanol (IPA) was used as read-across. A read-across justification
for IPA is provided in an attachment in Section 13 of this dossier. In a
long-term toxicity study of IPA, groups of male/female F-344 rats and
CD-1 mice were exposed to vapor at target concentrations of 0, 500, 2500
or 5000 ppm, 6 hours/day, 5 consecutive days/week for 78 weeks (mice) or
104 weeks (rats) (Burleigh-Flayer et al., 1997). Chronic IPA exposure
produced clinical signs of toxicity, changes in body weight and
urinalysis and urine chemistry indicative of kidney effects in the 2500
and 5000 ppm groups. These changes were considered by the study authors
to be indicative of chronic progressive nephropathy, a spontaneous
lesion in aging rats which tends to be more prominent in male than
on human and animal evidence relating to CPN, Hard et al. (2009) have
concluded that this is a rodent-specific lesion which should not be
regarded as an indicator of human toxic hazard. The only neoplastic
lesion which was elevated was an increase in Leydig cell tumors in male
rats.This is also a common spontaneous
lesion in the male F-344 rat strain. The authors observed that the
statistical significance attached to the frequency of this observation
was probably due to the unusually low incidence in the concurrent
control group. No increase in neoplastic lesions was noted in female
rats or male/female mice.
Hard, Kent J. Johnson, Samuel M. Cohen;Critical Reviews in
Toxicology;2009, Vol. 39, No. 4, Pages 332-346;A comparison of rat
chronic progressive nephropathy with human renal disease.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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