CAFEINE CAS : 58-08-2 - UNEP Chemicals

OECD SIDS CAFFEINE
5. TOXICITY DATE: 04-MAR-2003
SUBSTANCE ID: 58-08-2
Clinical chemical examinations were performed on animals from
the 94, 375, and 1500 ppm and control groups. Microscopic
pathology was performed on all lesions appearing grossly and
routinely in all major systemsin the high dose and control
groups.
Mean body weights were significantly depressed (by >10%) in
males treated with 188, 375, and 750 ppm. Final mean body
weights were significantly decreased at 94, 188, 375 ppm
(both sexes), and at 750 ppm (males only). Food consumption
was unaffected. Water consumption was decreased by 10% and
more in the groups given 1500 and 750 ppm (both sexes) and
increased by 10% and more in all other treated group (both
sexes). No significant clinical symptoms were recorded in
any group.
Clinical chemistry indicated significant decreases in the
levels of serum amylase (1500 ppm, both sexes), serum
aspartate aminotransferase (375 ppm, females), and alanine
aminotransferase (1500 ppm, females). However, no
dose-related trends were indicated.
There were no significant treatment-related gross or
microscopic lesions, though microscopic examination revealed
some alterations of the salivary gland at the upper limits
of normal in the high dose group.
According to the authors, these results indicated that the
maximum tolerated dose to be used for a 2-year chronic
bioassay should be 1500 ppm; doses of 0, 375, 750, and 1500
ppm were recommended for this study.
Test condition: Groups of 12 animals/sex.
Test substance: caffeine; according to the authors, purity was 99.9%
(analyzed)
Reliability: (1) valid without restriction
guideline study (NTP)
Flag: Critical study for SIDS endpoint
03-MAR-2003 (96)
Species: mouse Sex: female
Strain: other: TO
Route of administration: dermal
Exposure period: 3 days
Frequency of treatment: twice daily
Post exposure period: none
Doses: 10 and 50 mM solution (ca. 1942, 9710 ug/ml)
Control Group: yes, concurrent vehicle
Method: other: no data
Year: 1984
GLP: no data
Test substance: other TS
Result: The aim of the study was to investigate nuclear enlargement
as an early change produced in mouse epidermis by
carcinogenic compounds when applied in the presence of a
tumor promotor. The test substance was applied to the shaved
dorsal skin at concentrations of 10 and 50 mM for 3 days; a
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