Registration Dossier
Registration Dossier
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EC number: 209-967-5 | CAS number: 599-61-1
Endpoint summary
Administrative data
Description of key information
Additional information
Three cases reporting acute exposed subject led to the LD50 in Humans estimated to be between 15 - 20 mg/kg bw, and the acute NOAEL to be 8 mg/kg bw.
Dapsone has been used for the treatment of leprosy and other infectious diseases as well as for the treatment of non-infectious inflammatory diseases, of which dermatitis herpetiformis is the most important one. It is considered that > 1 million patients have been treated. The evaluation of side-effects has been performed in a review. The clinically most important side-effect of dapsone treatment is methemoglobin formation.
A study cohort consisted of all 115'400 Australian army associates treated during their service in Vietnam (1965 -1972) with dapsone for malaria prophylaxis. Each service was for at least one year. Relative mortality and cancer incidence rates were calculated for Army personnel who served in Vietnam and consumed dapsone as part of the malarial prophylaxis treatment compared to Army personnel who did not consume dapsone during their Vietnam service. Standardised ratios comparing the two treatment groups to the Australian population were also calculated. The retrospective cohort study performed in 2005 revealed no evidence that dapsone exposure was associated with an increase in total cancer incidence.
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