Registration Dossier

Toxicological information

Carcinogenicity

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Administrative data

Description of key information

A cohort study on 40.204 Australian Army vetrans assesses long term health effects from exposure to Dapsone during Vietnam service, mortality was assessed for over 30 years since exposure and cancer incidence follow-up was for 19 years. There was no statistically significant difference in non-cancer mortality between those who consumed Dapsone and those who did not. There was a modest but statistically significant lower than expected overall cancer incidence, and for some specific cancers, a lower than expected mortality for the Dapsone exposed group.
This study concludes that those who took the anti-malarial Dapsone/Paludrine prophylaxis have not experienced adverse health, as measured by mortality and cancer incidence, compared to those veterans who took anti-malarial treatment without Dapsone.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Study duration:
chronic
Species:
other: retrospective cohort study on Australian Army veterans

Additional information

Justification for selection of carcinogenicity via oral route endpoint:
Also, according to IARC, Dapsone is not classifiable as carcinogen.

Justification for classification or non-classification

A cohort study on 40.204 Australian Army vetrans concludes that those who took the anti-malarial Dapsone/Paludrine prophylaxis have not experienced adverse health, as measured by mortality and cancer incidence, compared to those veterans who took anti-malarial treatment without Dapsone.

Also regarding IARC evaluation, there is no reason to classify Dapsone (4,4'-DDS) as a potential Human carcinogen.