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EC number: 204-465-2
CAS number: 121-33-5
LD50 oral (rat): 3978 mg/kg bw. Vanilline is not harmful by ingestion.LD50 dermal (rat): > 2000 mg/kg bw (no mortality observed at this dose). Vanilline is not harmful by dermal route.
Acute oral toxicity
studies were available which 3 of them were of validity 2.
data gave LD50 results above 2000 mg/kg, except results in Jenner
(1964) publication (1580 mg/kg in rat and 1400 mg/kg in guinea pig)
which was not taken into consideration, because it was validity 3
according to Klimish scale.
three studies with validity 2 (Hazleton 1992, Monsanto 1955 and 1976,)
were selected as key studies. The results were similar, the study ofHazleton(1992),
was the most detailed.
this study groups of fasted, 5-7 weeks old Sprague-Dawley rats (5/sex)
were given a single oral dose of crystallised Vanilline (purity
unknown) in CMC at doses of 0, 2000, 2510, 3160 and 3980 mg/kg bw and
observed for 15 days. Lethargy, prostration or subdued behaviour were
observed in all groups, and sialorrhea was observed in some animals.
Death occurred in animals tested of main experiment: for limit test
2/10 at 2000 mg/kg bw for principal study: 0/10 at 0 mg/kg bw 1/10 at
2000 mg/kg bw 2/10 at 2510 mg/kg bw 3/10 at 3160 mg/kg bw 5/10 at 3980
mg/kg bw. In the preliminary study, 3 groups of 2 males and 2 females
per group were treated under the same conditions as those employed in
the main study, at the dose levels of 500, 1000 and 2000 mg/kg.
Animals were observed for 15 days. Neither clinical signs nor death
were seen at all dose level tested.
LD50 Combined Males/Females = 3978 mg/kg bw (95% C.I. 2484 - 6368
mg/kg bw) according to Bliss' method
key studies provided a LD50 range from 3300 to 3978 mg/kg.
to classification criteria of EC regulation 1272/2008 Vanillin
should not be classified for acute oral toxicity.
one study on rat (Makaruk, 1980) was available. In this study, only
one dose was tested which is the saturated vapour concentration. It
gave a result of LC50 above 41.7 mg/m3after 4 hours
exposure for rats and 2 hours for mouse with no other details. It was
in validity 3 according to Klimish scale, and no purpose flag was
an acute dermal toxicity study (Hazleton, 1991) of validity 2, groups
of 5 -7 weeks old Sprague-Dawley rats (male / female) were dermaly
exposed to Vanillin for 24 hours to approximately 10% area of the body
at doses of 2000 mg/kg bw. Animals then were observed for 14 days.
the preliminary study, 2 males and 2 females per group were treated
under the same conditions as those employed in the main study, at the
dose levels of 1000 and 2000 mg/kg. No deaths were seen at all dose
level tested of 2000 mg/kg.
LD50 Combined>2000mg/kg bw. No clinical sign, except
yellowish coloration of the skin and no mortality occurred at this
criteria of EC regulation 1272/2008 Vanillin should not be
classified for acute dermal toxicity based on the LD50 in male and
Regarding data available, vanilline was not
classified for acute toxicity by oral and dermal routes.
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