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EC number: 200-661-7
CAS number: 67-63-0
A supportive GLP, oral, developmental neurotoxicity study with
isopropanol (IPA) conducted according to OECD Guideline 426 in
Sprague-Dawley rats reported a NOAEL of 700 mg/kg bw for maternal
toxicity effects, and a developmental neurotoxicity NOAEL of 1,200 mg/kg
bw (the highest dose tested). A supportive 9 to 13-week inhalational
toxicity study in rats (comparable to OECD Guideline 413) did not report
a NOAEL at the only concentration level tested (5000 ppm).
The neurotoxicity of isopropanol (IPA) was evaluated in a supportive
GLP, oral developmental neurotoxicity study, in Sprague-Dawley rats
(Bates and de Serres, 1991). This study was conducted
according to OECD Guideline 426. Pregnant rats were
exposed to 200, 700, or 1200 mg/kg bw/day from gestation days 6 through
21. Dams were allowed to undergo parturition and
selected offspring were assessed for motor activity, auditory startle
reflex habituation, and habituation tests. One subset
of animals was sacrificed on post-natal day 22 for neuropathological and
brain weight measurements. One dam in the 1200 mg/kg group died on
post-natal Day 15. There were no significant findings
in any of the assessed parameters. The NOAEL for
developmental neurotoxicity was the highest dose tested, 1200 mg/kg bw. The
NOAEL for maternal toxicity was 700 mg/kg bw due to the death of 1 dam
at the 1200 mg/kg bw dose level.
supportive 9 to 13-week inhalational toxicity study conducted according
to OECD Guideline 413 did not report a NOAEL at the only IPA
concentration level tested (5000 ppm) (Burleigh-Flayer and Hurley, 1994). Findings
at the 5000 ppm dose level included hypoactivity and lack of startle
activity in some rats, transient changes in body weight, and recoverable
increases in mean cumulative motor activity. An
acute inhalation study available in the public domain (Gill et al., J
appl Toxicol 1995; see chapter 7.2.2), reported acute transient
concentration-related narcosis and/or sedation and minor decreases in
motor function after IPA treatment. This would lead to classification as
STOT 3, H336. In addition, IPA is classified STOT3/H336 in Annex VI
of Regulation (EC) No. 1272/2008 (index
According to CLP classification criteria, the substance does meet the
criteria for classification and labelling for this endpoint (STOT single
exposure category 3, H336 - May cause drowsiness or dizziness), as set
out in Annex VI of Regulation (EC) No. 1272/2008.
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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