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EC number: 201-158-5
CAS number: 78-92-2
A skin irritation study on s-butanol in rabbits, which was performed according to test guidelines, has demonstrated that the compound is not irritating to rabbit skin. s-Butanol induced serious eye damage in 1 out of 6 rabbits after a single application in a study performed according to test guidelines. Mild reversible irritation was observed in all other animals. Therefore, s-butanol is considered to be a reversible eye irritant.
A skin irritation study on s-butanol has been performed in
accordance with OECD Guidelines for the Testing of Chemicals No. 404 and
in compliance with GLP (Price, 1986). In this study, 3 male and 3
female New Zealand White rabbits were exposed to 0.5 mL of undiluted
s-butanol on the shorn dorsal region under semi-occlusive conditions.
Animals were exposed to the test compound for 4 hours and observations
were recorded at 4, 24, 48, and 72 hours and 7 days after
application. Skin reactions were scored according to a prescribed
numerical system. In all animals, no skin reactions were observed
following the application of s-butanol to rabbit skin for 4 hours. Based
on the results of this study, the authors stated that s-butanol is a
non-irritant to rabbit skin. s-Butanol is not classified as a skin
irritant according to the CLP classification criteria.
An eye irritation study on s-butanol has been performed in
accordance with OECD Guidelines for the Testing of Chemicals No. 405 and
in compliance with GLP (Price, 1986). In this study, 0.1 mL of
undiluted s-butanol was instilled into one conjunctival sac of each of 3
male and 3 female New Zealand White rabbits. Ocular changes were
assessed 1, 4, 24, 48, and 72 hours and 7 days after treatment, and
scoring was performed according to guideline methods.
Instillation of s-butanol caused moderate initial pain and induced
moderate conjunctival inflammation with some discharge in all animals
within 1 hour of dosing. The swelling and discharge had largely cleared
by 4 hours; however, redness persisted in 3 animals up to 7 days after
treatment. These animals and one other animal had impaired iritic
response and/or slight corneal opacity between 24 and 72 hours after
treatment. These effects were cleared by 7 days in all except for one
animal, which had an intensely opaque eye over the entire cornea with no
iritic response. Recovery was considered not possible, and thus, this
animal was killed for humane reasons. All ocular effects observed in the
remaining rabbits were fully reversible by 14 days. The mean scores at
24, 48, and 72 hours are 1.5, 0.3, 0.5, and 0.2 for redness, chemosis,
corneal opacity, and iritic effects, respectively. Under the conditions
of this study and in view of the response in one animal, s-butanol was
considered by the investigators to be corrosive to rabbit eyes. However,
considering that only mild, reversible irritation (insufficient to
classify) was observed in the majority of animals (5 out of 6), the
irreversible effects observed in one animal were likely resultant of an
idiosyncratic reaction. It is unclear from this study whether the lack
of reversibility is directly related to the test compound. Therefore,
s-butanol is considered to be a reversible eye irritant. s-Butanol is
classified as a Category I (causes serious eye damage) according to the
CLP classification criteria.
Sensory and pulmonary irritation potential of s-butanol at
concentrations up to 15300 ppm were investigated in groups of
trachea-cannulated or non-cannulated mice (Hansen and Nielsen, 1993).
Based on this publication, a weak potential for respiratory irritation
was reported; however, further data to justify a classification for
respiratory tract irritation was not available.
Skin irritation: The substance does not meet the criteria for
classification and labelling for this endpoing, as set out in Regulation
(EC) No. 1272/2008.
Eye irritation: According to CLP classification criteria, this substance
does meet the criteria for classification and labelling for this
endpoint (category II: causes serious eye irritation), as set out in
Regulation (EC) No. 1272/2008.
Respiratory irritation: According to CLP classification criteria, the
substance does meet the criteria for classification and labelling for
this endpoint (STOT single exposure category 3, H335 - May cause
respiratory irritation), as set out in 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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