American Chemistry Council/Thiuram Test Plan & Robust Summary

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Date: 28-SEP-2001
5. Toxicity ID: 97-77-8
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Species: mouse Sex: male/female
Strain: B6C3F1
Route of admin.: oral feed
Exposure period: 108 weeks
Frequency of
treatment: daily
Post. obs.
period:
Doses: 0, 100, 500, 2000 ppm
Result:
Control Group: yes, concurrent no treatment
Method:
Year: GLP: no data
Test substance: other TS
Remark: Dose groups consisted of 50 male and 50 female animals.
Females were dose 0, 100 or 500 ppm whereas the males were
dosed 0, 500 or 2000 ppm. The control group consisted of 20
male and 20 female animals. All surviving animals (65%) were
killed at the end of the treatment period. No tumors
occurred at incidences significantly different form the
controls. The test material was concluded to be
non-carcinogenic.
Source: Akzo Nobel Chemicals b.v. Amersfoort
Test substance: Technical-grade test material was mentioned to be used.
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Species: Sex:
Strain:
Route of admin.:
Exposure period:
Frequency of
treatment:
Post. obs.
period:
Doses:
Result:
Control Group:
Method:
Year: GLP:
Test substance:
Remark: A study was conducted in which Sodium nitrite and TETD alone
and a mixture of 0.1% TETD and 0.2% sodium nitrite were
administered to Fisher F344 rats for 78 weeks via their
diet. Each group consisted of 20 male and 20 female animals.
The rats fed either TETD or sodium nitrite alone did not
develop any tumors. Of the animals fed the mixture 10 males
and 12 females developed tumors of oesophagus, tongue,
squamous stomach or nasal cavity. The author did not
attribute the tumors to the separate chemicals but to the
reaction of TETD and sodium nitrite in the stomach to
nitrosodiethylamine, a nitrosamine which also gave rise to
tumors when administered as such.
Source: Akzo Nobel Chemicals b.v. Amersfoort
(27)