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EC number: 204-465-2
CAS number: 121-33-5
Vanilline is not irritating to the skin, and irritating to the eyes, with reversibility within 8 days.
Vanillin which composition is described in chapter 1, three studies were
available. One of them performed on rat was selected as key study
(Hazleton 1991, validity 1), and another one performed on rabbit (Birck
1976, validity 2) as supporting study. The third one tested on guinea
pig (Makaruk 1980, validity 3) was not taken into account for assessment
because the original reference was in Russian language.
two selected studies gave the same results:not irritating to the skin.
Summaries of these studies are the following:
an acute dermal toxicity study (Hazleton,
1991), young adult Sprague-Dawley rats (5/sex) were dermally exposed to
2000 mg/kg bw of Vanilline Cristallisée (purity unknown) in water for 24
hours to 10% body surface area. Test sites were covered with a
semi-occlusive dressing for 24 hours. Animals then were observed for 14
days. Irritation was scored by the method of EU guideline. In this
study, cristallised Vanillin is not a dermal irritant based on the
absence of skin reaction. Only a yellowish colour was observed from day
2 to 14.
a primary dermal irritation study (Birck, 1976),New
rabbits (6 animals) were dermally exposed to0.5
vanillin (purity unknown) for 24 hours. In this study, vanillin was not
a dermal irritant.
Three studies performed
on rabbit were available on Vanillin which composition was described in
chapter 1. One of them was selected as key study (CIT 2007, validity 1),
and another one (Birck 1976, validity 2) as supporting study. The third
one (Makaruk 1980, validity 3) was not taken into account for assessment
because the original reference is in Russian language.
The twoin vivoselected
studies gave the same result: irritating to the eyes. Summaries
of these studies are the following:
In a primary eye
irritation study (CIT, 2007) 100 mg of Vanilline (pure product) was
instilled into the conjunctivae sac of right eye of a young adult New
Zealand White rabbit (3 males). Animals then were observed for 8 days
(period of reversibility). Irritation was scored according to the OECD
and EU guidelines. Mean scores calculated for each animal over 24, 48
and 72 hours were 1.0, 1.7 and 2.0 for chemosis, 2.0, 2.0 and 2.0 for
redness of the conjunctiva, 0.7, 0.7 and 0.3 for iris lesions and 2.0,
2.0 and 2.0 for corneal opacity. In this study, Vanillin is irritating
to the eye.
a primary eye irritation study [Birck, 1976], 0.1 mL of vanillin (purity
unknown) undiluted was instilled into the conjunctivae sac of New
Zealand White rabbits (6 animals) for 24 hours. Animals then were
observed for 7 days. Irritation was scored by the method of Kay and
Calandra, and in this study, vanillin is an eye irritant.
classification criteria of EC regulation 1272/2008 Vanillin was not
classified as irritant for the skin, and vanillin should be classified
as irritant for the eyes Xi; R36 or category 2 under CLP.
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