Registration Dossier

Toxicological information

Toxic effects on livestock and pets

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Administrative data

Endpoint:
toxic effects on livestock and pets
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Adequate report of non-standard investigation

Data source

Reference
Reference Type:
publication
Title:
Identification and Characterization of Toxicity of Contaminants in Pet Food Leading to an Outbreak of Renal Toxicity in Cats and Dogs
Author:
Dobson, RLM et al
Year:
2008
Bibliographic source:
TOXICOLOGICAL SCIENCES 106(1), 251–262

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Research relating to the major recall of pet food that occurred in Spring 2007 in North America
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Melamine and cyanuric acid were obtained from Sigma-
Aldrich (Milwaukee, WI).

Test animals

Species:
other: rats, cats and dogs
Details on test animals and environmental conditions:
not available

Administration / exposure

Route of exposure:
oral: applied on feed
Vehicle:
unchanged (no vehicle)

Results and discussion

Details on results:
Clinical observations of acute renal failure in cats and dogs were associated with consumption of wet pet food produced by
a contract manufacturer producing for a large number of companies. The affected lots of food had been formulated with wheat gluten originating from China. Pet food and gluten were analyzed for contaminants using several configurations of highperformance liquid chromatography (HPLC) and mass spectrometry (MS), which revealed a number of simple triazine compounds, principally melamine and cyanuric acid, with lower concentrations of ammeline, ammelide, ureidomelamine, and N-methylmelamine.
Infrared microspectroscopy on individual crystals from rat or cat (donated material from a veterinary clinic) kidneys confirmed that they were melamine-cyanuric acid cocrystals.

Rats given both melamine and cyanurate, but not melamine or cyanurate alone, showed crystals in the kidney upon three day dosing.

Applicant's summary and conclusion