JOURNAL  OF  THE  AMERICAN  COLLEGE  OF  TOXICOLOGY  Volume  3,  Number  5,  1984  Mary  Ann  Liebert,  Inc.,  Publishers 

 Final  Report  on  the  Safety  Assessment  of Methylparaben,  Ethylparaben,  Propylparaben,  and  Butylparaben 

 The  Parabens  are  esters  of  p-hydroxybenzoic  acid  (PHBA)  and  are  the  most  commonly  used  as  preservatives  in  cosmetic  formulations.  Data  obtained  from  chronic  administration  studies  indicate  that  Parabens  are  rapidly  absorbed,  metabolized,  and  excreted.  Acute  chronic  and  subchronic  toxicity  studies  in  animals  indicate  that  Parabens  are  practically  nontoxic  by  various  routes  of  administration.  Methyl-  paraben  and  Ethylparaben  at  100  percent  concentration  were  slightly  irritating  when  instilled  into  the  eyes  of  rabbits.  Numerous  in  vitro  mutagenicity  studies  indicate  that  the  Parabens  are  non-  mutagenic.  Methylparaben  was  noncarcinogenic  when  injected  in  rodents  or  when  administered  intravaginally  in  rats.  Cocarcinogenesis  studies  on  Propyl-  and  Methylparaben  were  negative.  Teratogenic  studies  on  Methyl-  and  Ethyl-  paraben  were  also  negative.  Parabens  are  practically  nonirritating  and  nonsensitizing  in  the  human  population  with  normal  skin.  Paraben  sensitization  has  been  reported  when  Paraben-containing  medicaments  have  been  applied  to  damaged  or  broken  skin.  Photo-contact  sensitization  and  phototoxicity  tests  on  product  formations  of  Methyl-,  Propyl-,  and/or  Butylparaben  gave  no  evidence  of  significant  pho-  toreactivity.  It  is  concluded  that  Methylparaben,  Ethylparaben,  Propylparaben,  and  Butylparaben  are  safe  as  cosmetic  ingredients  in  the  present  practices  of  use.

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