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EC number: 201-158-5
CAS number: 78-92-2
The skin sensitisation potential of s-butanol was assessed in a
study performed according to OECD Guidelines for the Testing of
Chemicals No. 406 and in compliance with GLP in male and female
Dunkin-Hartley guinea pigs (de Jouffrey, 1997). In the main study, 10
animals/sex comprised the s-butanol test group and 5 animals/sex
comprised the vehicle control group. The intradermal induction was
carried out with 0.1 mL of 5% (w/w) of s-butanol in vehicle (paraffin
oil), and epicutaneous induction was performed with 0.5 mL of undiluted
s-butanol to the dorsal area under occlusive conditions. The challenge
exposure also was conducted with 0.5 mL of undiluted s-butanol.
Additionally, all animals were dermally exposed to 0.5 mL of 10% w/w
sodium lauryl sulphate (SDS) in vaseline 24 hours prior to topical
sensitisation of the skin area in order to induce local irritation
(s-butanol was shown to be moderately irritating with no necrosis or
ulceration of the skin via intradermal injection and non-irritating via
the topical application in the preliminary test). Skin reactions were
observed and recorded 1 hour after dermal induction and 24 and 48 hours
after the challenge exposure, all according to the grading scale by
Magnusson and Kligman. No positive skin reactions were observed in all
animals 24 or 48 hours after challenge. Under the experimental
conditions and according to the maximization method of Magnusson and
Kligman, no cutaneous reactions attributable to the sensitisation
potential of s-butanol were observed in guinea-pigs. Therefore, the
results of this study demonstrated that s-butanol showed no evidence of
contact skin sensitisation in guinea pigs.
The low potential of s-butanol to cause skin sensitisation is
supported by another skin sensitisation test in which no guidelines was
followed. The method followed, however, was similar to that of OECD and
the study was performed in compliance with GLP. The scoring method of
Magnusson and Kligman was followed. The intradermal induction was
carried out with 0.1 mL of 0.1% of s-butanol in vehicle (corn oil), and
epicutaneous induction was performed with 0.3 mL of 50% of s-butanol to
the dorsal area under occlusive conditions. The dermal challenge
exposure also was conducted with 0.1 mL of 25% of s-butanol. s-Butanol
was reported to show no positive responses in rabbits (10/sex) at either
24 or 48 hours after removal of the challenge patches (Price, 1986).
The substance does not meet the criteria for classification and
labelling for this endpoint, as set out in Regulation (EC) No. 1272/2008.
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