Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
other: Clinician's report
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Citation in reliability 2 publication
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Study type:
clinical case study
Endpoint addressed:
repeated dose toxicity: oral

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Results and discussion

Applicant's summary and conclusion

Conclusions:
Retrospective studies of children receiving salicylate therapy in the management of juvenile rheumatoid arthritis did not uncover any cases in which hepatomegaly (as seen in dogs) could be associated with massive daily doses of salicylate over prolonged periods of time. The reviews of human case histories (secondary reference, Abbott and Harrisson, 1978) suggest that the salicylate that the salicylate produced hepatomegaly in dogs are not relevant to humans.
Executive summary:

Abbott and Harrisson, 1978 conducted a study in dogs to ascertain whether or not hepatomegaly was associated with massive daily dosages of salicylates. In order to determine whether findings were relevant for humans, the assistance of seven clinicians was solicited to review case histories of children receiving salicylate therapy and whose periodic examinations had included records of liver palpation.

A total of 218 cases were reported upon (see "cross reference to other study"). Salicylate dosages ranged up to 4800 mg/day over periods of up to 8 or 10 years. It was consensus of the reporting clinicians that salicylate therapy does not cause hepatomegaly. Nor does salicylate therapy interfer with growth or weight gain. It was reported however, that hepatomegaly is occasionally seen upon admission or during the course of treatment. Such was viewed as a concurrent happening which if encountered regresses as the disease condition is brought under control by salicylate therapy.