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EC number: 204-465-2
CAS number: 121-33-5
animal studies were available for skin sensitization with Vanillin.
Amongs of them, four were of reliability 2; One of them was selected
as key study and had reliability 2 (Hazleton,
1992), and the others were selected as supporting studies with
reliability 2 (Basketter, 2001; Gad, 1986; Wang, 1987).
study was a maximization test, and the summary is the following:
dermal sensitization study (Hazleton,
1992) with Vanilline cristallisée (purity unknown) in ethanol, young
adult Dunkin-Hartley guinea pigs (10/sex) were tested using the method
of Maximization. The doses tested for induction and challenge phases
were: 35% (intradermal induction), 73% (epicutaneous induction and
Signs of irritation were noted during the induction.
The macroscopic examinations did not reveal any lesion of delayed
hypersensitivity in the 20 treated animals. No cutaneous abnormality
was noted in the 20 guinea pigs examined in the control group.
From the result obtained under the experimental conditions employed,
vanillin did not provoke any reaction of cutaneous sensitization in
the animals examined.
studies were a LLNA and a MEST tests. In the first one (Basketter et
al., 2001), CBA/Ca mice (4 females) were testing with Vanillin in
acetone/olive oil (4:1 v/v), using the method of Local Lymph Node
Assay (LLNA) at doses of 0, 2.5, 5, 10, 25 and 50%. During the study
no positive lymphoproliferative response were observed at all doses
tested. In this study, Vanillin was not a dermal sensitizer.
study of Gad et al (1986) CF-1 female mice were tested in a Mouse Ear
Swelling Test (MEST) with Vanillin (purity unknown).All
mice were topically dose with 100 µl of Vanillin in solvent (50%) or
solvent alone (controls) applied to the center of the shaved region.
The application was allowed to dry before the animal was returned to
its cage. Tape stripping and topical application of the appropriate
solution to the stomach were repeated for 3 additional consecutive
days after the final topical application to the stomach, 20 µl of
Vanillin in solution (50%) was applied to the left ear of each animal
(test and control) and 20 µl of the solvent was applied to the right
ear. At both 24 an 48 hours after this challenge, animals were lightly
anesthetized with ether and the thicknesses of both ears were
measured. Vanillin presented a percentage of swelling of 4%. In these
conditions Vanillin could be considered as negative in MEST, and
Vanillin was not sensitizing in this test.
of Wang et al (1987) investigated the skin irritation and sensitizing
potential of chemicals in manufacture of Vanillin, using specific
process with urotropine. In this study, male and female albino guinea
pig were tested with Vanillinat
100% using a modified Buehler test and at 100 % using a patch test. No
signs of irritation were noted. In Buehler test the induction was done
by topical application (occlusive) at 10% with Vanillin in petrolatum
for 24 -hour application, 3 times in 2 weeks on napes of 10 animals.
The challenge was done 2 weeks after final induction by topical
application (occlusive) with 100% Vanillin on left flanks. No signs of
sensitization were observed. A cross-reactivity was done with other
substances and did not revealed cross-sensitization. Based on these
results, Vanillin was neither irritant nor sensitizer.
other studies were not taken into account, because they had
reliability 3 or 4, due to lack of details of the study, to permit to
consider them for the assessment.
Human data with validity 2 confirmed the results obtained in animal
studies. These studies were Patch tests on Humans (Hausen, 2001;
Francalanci, 2000; Wang, 1987).
study of Hausen (2001), occlusive patch of 5% of Vanillin were applied
for 24h to 102 volunteers already positive to BalsamPeru. Vanillin
gave negative results on patients already sensitized with Balsam of
study of Francalanci (2000), 54 patients who presented eczematous
lesions on the lips probably due to toothpastes, received occlusive
patch test with 10% of Vanillin for two days. 1/54 patient react
positively to Vanillin, it is not sufficient to consider Vanillin as
study of Wang (1987), Vanillin was tested with other substance of
urotropine process for the manufacturing of the Vanillin. 0/45
patients had positive results, so Vanillin was not sensitizing in this
patch test study
section 7.10.4 for more details.
the results available indicated that Vanillin was not a
sensitizer.According to classification criteria of EC regulation
1272/2008 Vanillin should not be classified for sensitisation.
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