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EC number: 200-315-5
CAS number: 57-13-6
Data from various species (including human volunteers) indicate that urea is not irritating to intact skin. The results of a guideline-compliant eye irritation study would trigger classification as an eye irritant, however medical surveillance data collected over several decades showed no adverse effects after direct contact with urea.
Frosch & Kligman (1977) (cited in WHO/JECFA evaluation) exposed human
volunteers to three daily applications of urea (dissolved in water) at
concentrations of between 7.5 -30%; applications were made to intact and
scarified skin. On abraded skin, slight irritation was seen with 7.5%
urea; marked irritation was seen with 30% urea. No effects were seen on
intact skin. In a study by Lashmar et al (1989)
application of 10% urea for 24 hours induced no discernible change in
the histological appearance of the skin. No evidence of skin irritation
was seen in a modern guideline study (Hooiveld, 2003).
It is notable that skin creams, commonly containing urea at
concentrations of between 5 -10% but also at concentrations of up to 25%
and higher are widely used for the treatment of dry/irritant skin
conditions, therefore it can be predicted that urea is not a skin
irritant. Urea is also naturally present in the stratum corneum at a
level of approximately 1%. It is also notable that no signs of local
irritation were noted in 28 -day and 25 -week repeated dose dermal
toxicity studies in the rat (Sato et al, 1977)
Urea was found to be a mild eye irritant in a guideline-compliant study
(Kirsch & Kersebohm, 1988), which would not require a classification
according to DSD, however require a classification according to CLP.
Medical surveillance data of 10 urea producing facilities were
collected, which showed no cases of eye irritation or related adverse
eye effects resulting from exposure to urea. (Borealis Agrolinz
No classification is proposed. There is no evidence from animal studies
or from human experience that urea is a skin irritant.
No classification is proposed. Although formally a classification as eye
irritant would be required according to CLP, medical surveillance data
show no adverse effects on eyes following direct contact.
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