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EC number: 201-302-7
CAS number: 80-70-6
In an OECD422 study, fertility indices and
any other reproductive parameters for male and female animals were not
impaired by test-substance administration at dose levels up to 100 mg/kg
bw/d (highest dose tested).
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 local NOAEL to 10 mg/kg bw/d. 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
No developmental toxicity was observed in a
GLP-compliant OECD422 screening study (2018).
Based on the results of the oral OECD422
study in rats, TMG does not need to be classified for reprotoxicity
according to the EU Classification, Labelling, and Packaging of
Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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