Registration Dossier
Registration Dossier
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EC number: 268-610-1 | CAS number: 68131-13-5
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
NA-DETA is expected to be readily bioavailable when exposed via oral/dermal/inhalation routes.
NA-DETA is expected to undergo extensive metabolic degradation process. No bioaccumulation potential can be derived.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Toxicokinetic profile of NA-DETA
No experimental data on toxicokinetics, metabolism and distribution is available.
The qualtitative toxicokinetic profile of NA-DETA can be soundly derived based on the following evidences:
- chemical structure
- phys-chem data
- preliminary cytotoxicity data in genotoxicity studies
- and repeated dose toxicity studies with NA-DETA and naphthenic acids.
NA-DETA can be characterized as amide linking naphthenic acids (CAS 1338 -24 -5) and diethyltriamine. The experimentally determined molecular mass (Mn:323 g/mol; Mw:462 g/ml) and fat solubility (LogPow of 1.8) are indicative of readily bioavailability when exposed orally or dermally. The exposure by inhalation is of no relevance since the substance is manufactured/used only as liquid form with no possibility of aerosol formation.
Upon resorption, NA-DETA is likely to undergo metabolic degradation process:
a) NA-DETA undergoes enzymatic hydrolysis at amide/imide bond; b) NA-DETA undergoes oxidative N-dealkylation at amide/imide bond, followed by deamination; c) NA-DETA undergoes oxidative N-dealkylation at secondary amine, followed by deamination/oxidation.
In the preliminary cytotoxicity data obtained in the genotoxicity studies, a remarkably reduced cytotoxicity of NA-DETA was observed with metabolic activation (with S9), supporting the mentioned degradation pathway as detoxification process.
Mode of action of NA-DETA upon prolonged exposure
Two types of mode of action of NA-DETA can be derived:
- local irritation effect on tissues nearby to the portal of entry
- systemic exposure to naphthenic acids
The local effects is expected to predominate at rather higher exposure dose levels while effect due to the systemic exposure to naphthenic acids is expected to become more distinctive as the exposure period increases.
According to the preliminary cytotoxicity data in genotoxicity studies (chromosome aberration test and gene mutation test in mammalian cells) NA-DETA is cytotoxic to mammalian cells. Further supporting evidences are that NA-DETA is irritating to skin and eyes. In the 14 -day repeated dose toxicity study in rats mortality occurred at dose levels of 500 mg/kg bw and higher and distinctive changes in the gastro intestinal tract was found in dead animalsUpon exposure to NA-DETA the tissues nearby to the portal of entry are expected to be the target organ, which means the gastro-intestinal tract, respiratory tract or contact site of skin depending on the exposure routes. The local effect may comprise tissue damage, inflammatory response and poor general health conditions. The reproduction performance may also be affected, but as of secondary nature In the 14-day repeated dose toxicity study in rats using NA-DETA as test material no evident toxic effect was observed at dose levels of 100 mg/kg bw and below. The NOAEL of 100 mg/kg bw for irritation effect can be considered to be valid also for long-term exposure, since the local irritation effect is a matter of concentration but not of the total systemic exposure level.
At dose levels not associated to local irritation effect the systemic exposure to naphthenic acid may become more important.The commercial naphthenic acid was investigated according to OECD Guideline 422. The treatment related effects were found in liver, kidney, thyroid and adrenals. Further the red blood cell count for males and the white blood cell count for females were altered, indicating systemic inflammation status.The naphthenic acid from Canadian oil sands tailings was investigated for its subchronic toxicity using female rats. At dose level of 60 mg/kg bw the liver was found as target organ and the author postulated the induction of hepatic detoxification enzymes as underlying mechanism. Both studies are indicating the liver as target organ and metabolic overload as underlying mechanism, which should be applicable for the prediction of repeated dose toxicity of NA-DETA. Upon repeated exposure to NA-DETA at dose levels not associated to local irritation effect, liver toxicity is likely to occur together with systemic effect related to metabolic overload.
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