Registration Dossier

Administrative data

Description of key information

Epidemiology: one negative study for hypospadia, two for SGA (small for gestational age) and one for eye effects plus cleft palate.

Several clinical case studies are available, describing fatal or near-fatal intoxications in humans after dermal contamination.  

Clinical observation: negative for cross-allergy between ethylester of MCA and MCA.

Additional information

Dermal contamination with molten MCAA or MCAA in concentrated solution can cause a severe systemic intoxication, often with fatal outcome depending on the size of the contamination.

In a patient with a contact dermatitis for the methyl ester of MCAA, no cross allergy for MCAA could be determined. this result cannot be used to determine the sensitising properties of MCAA

No relationship between maternal exposure to MCA (as Disinfection By-Product in drinking water) and occurence of hypospadia, SGA, eye effects or cleft palate.