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EC number: 201-302-7
CAS number: 80-70-6
In a GLP-compliant OECD422 study (28 days repeated dose +
reproduction/developmental toxicity screening) TMG was given to rats
orally ba gavage (2018). TMG was given daily as a solution to groups of
10 male and 10 female Wistar rats (F0 animals) at dose levels of 0, 10,
30, and 100 mg/kg bw/d. Deionized water served as vehicle. The duration
of treatment covered a 2-week premating period and mating in both sexes
(mating pairs were from the same test group) as well as entire gestation
and lactation period in females up to one day prior to the day of
schedule sacrifice of the animals. The test substance preparation
analyses confirmed: Stability of the test-substance preparations for a
period of 7 days at room temperature, homogeneous distribution of the
test substance in the vehicle, correctness of the prepared
concentrations. Effects: The following test substance-related, relevant
findings were noted: Local effects on the glandular stomach in
individual female animals related to the corrosive potential of the test
item. For all other organs/endpoints/parameters exmanied: No
treatment-related, adverse effects were observed.
CONCLUSION: Under the conditions of this Combined Repeated Dose Toxicity
Study with the Reproduction/Developmental Toxicity Screening Test, the
oral administration by gavage of 1,1,3,3-Tetramethylguanidine to Wistar
rats revealed signs of local toxicity at dose levels of 30 mg/kg bw/d
and above in female animals indicated by erosions in the glandular
stomach. However, the no observed adverse effect level (NOAEL) for
general systemic toxicity was set to 100 mg/kg bw/d for male and female
Wistar rats. The NOAEL for reproductive performance and fertility was
also set to 100 mg/kg bw/d for male and female Wistar rats. The NOAEL
for developmental toxicity was 100 mg/kg bw/d.
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