Registration Dossier
Registration Dossier
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EC number: 221-201-1 | CAS number: 3030-47-5
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
The information about toxicokinetics was very poor. No concrete study related to toxicokinetic behaviour of the substance Pentamethyldiethylentriamine was found by literature search in free or commercial sources. Estimation of the substance behaviour in the organism was performed, based on toxicological studies results only - acute and repeated dose toxicity and reproduction/developmental study.
Conclusions:
The test substance after single oral administration of high dose level invoked death of animals, and clinical and pathological findings were observed. The test substance penetrated into organism after single oral application.
After acute dermal exposure, the local changes of test area (irritation, necrosis) were irreversible. The substance is corrosive for skin. No systemic toxicity was observed, so the substance did not enter the organism through the skin. After acute eye exposure, the substance caused irreversible local effects on eye of the test animals. No systemic effects were reported. In experiments with acute inhalation exposure, no systemic toxicity was reported.
Repeated oral exposure of the substance resulted in entering into organism and its systemic distribution. The main target organ was liver. After oral administration, the test substance caused systemic intoxication of organism. It was quickly absorbed from digestive tract and systemically distributed through the body (hours). Through the blood circulation, it affected heart, liver, lungs, brain, etc.
Repeated whole-body exposure of rats to the vapor of the test substance caused extensive irritation of the upper respiratory tract, skin and eyes. The changes observed were indicative of nonselective localized irritation to tissues by exposure to the test material. Only local effects were observed, no systemic toxicity.
With respect to the results of reproduction toxicity part of repeated dose study it was not possible to confirm penetration through the placental barrier.
Key value for chemical safety assessment
Additional information
Based on the fact that there are no available toxicokinetic studies and hence no specific data on the oral, dermal and inhalation absorption rates for the substance tested, the absorption rates used in the DNEL derivations were the default values based on ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8: Characterizationof dose [concentration]-response for human health.
The default values were used as follows:
Oral absorption in rat = oral absorption in human
Oral absorption in rat = dermal absorption in human
50% absorption by oral route in rat = 100% absorption for inhalation in human
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