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EC number: 205-633-8
CAS number: 144-55-8
Sodium bicarbonate was not irritating to
rabbit skin and eyes in the GLP-compliant studies, performed according
to OECD Guidelines 404 and 405 and EPA OTS 798.4470 and OTS 798.4500
irritating properties of sodium bicarbonate have been studied in 2
GLP-compliant studies, performed according to OECD Guideline 404 and EPA
Guideline OTS 798.4470. In the first study, 0.3 g of the test substance
(0.5 ml bump volume) was applied to the shaved skins of 3 male rabbits
for 4 hours under semi-occlusive conditions. One rabbit had a slight
erythema (score 1) 1 hour after the test patch removal, which was
resolved at 24 hours examination. Another had slight erythema (score 1)
observed 24 hours after the test patch removal, which was resolved at 48
hours examination. In the second study, 0.5 g of the test substance,
moistened with distilled water prior to application, was applied under
semi-occlusive conditions to clipped skins of 3 male and 3 female
rabbits. Very slight erythema and oedema were noted at 1 hour
post-application (scores 0.7 and 0.2, respectively), which were fully
resolved at 48 hours examination. Based
on the results of these
two studies, sodium bicarbonate is concluded to be not irritating to
potential of sodium bicarbonate has been studied in two GLP-compliant
studies, performed according to OECD Guideline 405 (Henkel, 1991b) and
EPA Guideline EPA OTS 798.4500. In the first study, 0.05-0.07 ml (bump
volume) of the test substance were instilled into the eyes of three
rabbits, the untreated eyes serving as negative controls. Twenty -four
hours post-instillation, the eyes were rinsed thoroughly with tepid
water and the reactions were scored using the Draize system. All rabbits
had a slight to moderate conjunctival erythema (scores 1-2) 1 hour after
the instillation, which was resolved at 48 hours observation. Two out of
three animals also exhibited mild chemosis (score 1), which was resolved
at 24 hours observation. In the second study, 0.1 g of the test
substance was instilled in the eyes of 9 rabbits. The treated eyes of
three rabbits were irrigated with 30 ml of physiological saline
approximately 20-30 seconds after installation of the test substance.
The eyes of the remaining six rabbits were not irrigated. The rabbits
were observed for four days. No corneal opacity was noted during the
washed and one unwashed eye exhibited iritis one hour after installation
treated eyes had conjunctivitis. The
incidence and severity of irritation decreased with time. All
ocular irritation cleared from the washed and unwashed eyes by days 3
and 4, respectively. Based on these results, sodium bicarbonate is
considered to be non-irritating to rabbit eye.
[partly taken from OECD SIDS on sodium
bicarbonate (2002), pg. 14 -15]
Based on the results of GLP-compliant
studies on skin and eye irritation in rabbits, performed according to
OECD and/or EPA guidelines, classification of sodium bicarbonate as skin
and eye irritant is not warranted according to
CLP 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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