Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Seven studies were available which 3 of them were of validity 2.
All 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.
The 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.
In 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.
Oral LD50 Combined Males/Females = 3978 mg/kg bw (95% C.I. 2484 - 6368 mg/kg bw) according to Bliss' method
The key studies provided a LD50 range from 3300 to 3978 mg/kg.
According to classification criteria of EC regulation 1272/2008 Vanillin should not be classified for acute oral toxicity.
Only 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 selected.
In 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.
In 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.
Dermal LD50 Combined>2000mg/kg bw. No clinical sign, except yellowish coloration of the skin and no mortality occurred at this dose.
According to classification criteria of EC regulation 1272/2008 Vanillin should not be classified for acute dermal toxicity based on the LD50 in male and female rats.
Regarding data available, vanilline was not classified for acute toxicity by oral and dermal routes.
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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Close Do not show this message again