Please use this identifier to cite or link to this item:
|Title:||Can acute dermal systemic toxicity tests be replaced with oral tests? A comparison of route-specific systemic toxicity and hazard classifications under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS)|
|Authors:||MOORE Nigel P; ANDREW David J; BJERKE Donald L; CRETON Stuart; DREHER David; HOLMES Thomas; PRIETO PERAITA Maria Del Pilar; SEIDLE Troy; ROWAN Tim G|
|Citation:||REGULATORY TOXICOLOGY AND PHARMACOLOGY vol. 66 p. 30–37|
|Publisher:||ACADEMIC PRESS INC ELSEVIER SCIENCE|
|Type:||Articles in periodicals and books|
|Abstract:||Acute systemic toxicity data (LD50 values) and hazard classifications derived in the rat following oral administration and dermal application have been analysed to examine whether or not orally-derived hazard classification or LD50 values can be used to determine dermal hazard classification. Comparing the oral and dermal classifications for 335 substances derived from oral and dermal LD50 values respectively revealed 17% concordance, and indicated that 7% of substances would be classified less severely while 76% would be classified more severely if oral classifications were applied directly to the dermal route. In contrast, applying the oral LD50 values within the dermal classification criteria to determine the dermal classification reduced the concordance to 15% and the relative ‘under-classification’ to 1%, but increased the relative ‘over-classification’ to 84%. Both under- and over-classification are undesirable, and mitigation strategies are discussed. Finally, no substance with an oral LD50 of >2000 mg/kg was classified for acute systemic toxicity by the dermal route, suggesting that dermal testing for acute systemic toxicity of such substances adds nothing to the hazard characterisation and should be removed from routine regulatory data requirements.|
|JRC Directorate:||Institute for Health and Consumer Protection Historical Collection|
Files in This Item:
There are no files associated with this item.
Items in repository are protected by copyright, with all rights reserved, unless otherwise indicated.