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D A Rutty

Publications and source records attributed to D A Rutty.

9 recordsLinked to original sources

Ocular tolerance assessment--integrated tier policy.

A tier scheme is proposed for the assessment of ocular tolerance as part of the safety evaluation of materials. The scheme has four stages: (1) physico-chemical characterization, (2) an in vitro cytotoxicity study, (3) a dermal tolerance study in rabbits and (4) initial and confirmatory ocular tolerance studies in rabbits. The assessment may be terminated at any of the stages, including during the course of the final stage. This tier system appears to provide a considered and careful approach to the requirement to assess the ocular tolerance of those materials for which conventional animal tests are not essential.

Animals↗

Methodological aspects of acute toxicity testing particularly LD50 determinations present use in development of new drugs.

It is essential to have an adequate understanding of the acute toxic effects of a new drug. It may not be necessary however to blindly follow the full classical median lethal assay on every occasion. The LD50 was developed to obtain the maximum accuracy from a modest experimental size. The objective of the study and the limitations of the assay should not be overlooked however and undue precision should not be sought. Methodological aspects including species and maximum and minimum doses will be discussed. Other methods and approaches to acute toxicity will be recommended with a more broad approach to acute toxicity than lethality alone.

Animal Husbandry↗