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Administrative data

Description of key information

Vanilline is not irritating to the skin, and irritating to the eyes, with reversibility within 8 days.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation:

Concerning 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.

The two selected studies gave the same results:not irritating to the skin. Summaries of these studies are the following:

In 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.

In a primary dermal irritation study (Birck, 1976),New Zealandwhite rabbits (6 animals) were dermally exposed to0.5 gof vanillin (purity unknown) for 24 hours. In this study, vanillin was not a dermal irritant.

 

Eye irritation:

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.

 In 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.

 

According to 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.



Effects on eye irritation: irritating

Justification for classification or non-classification