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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Currently viewing:

Administrative data

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

Data source

Reference Type:
study report

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl salicylate
EC Number:
EC Name:
Methyl salicylate
Cas Number:
Molecular formula:
methyl salicylate
Constituent 2
Chemical structure
Reference substance name:
Salicylic acid
EC Number:
EC Name:
Salicylic acid
Cas Number:
Molecular formula:
2-Hydroxybenzoic acid

Results and discussion

Applicant's summary and conclusion

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.