Cyclohexanamine, 4,4'-methylenebis[N-(1-methylpropyl)-

Endpoint summary

Description of key information

Short description of key information on bioaccumulation potential result: 
Absorption: Absorbed throught the skin, intestinal tract and lungs. 
Distribution: Widely distributed and systematically available throughtout the body.
Metabolism: There are not enought data available to estimate the route of metabolism and possible metabolites.
Excretion: Likely to be exreted feaces and urine.

Key value for chemical safety assessment

Bioaccumulation potential:

no bioaccumulation potential

Additional information

No studies relating to toxicokinetics has been conducted. The assessment of the toxicokinetic behaviour is based on the available information of the physical and chemical properties of the substance and the data obtained from animal studies.

Clearlink 1000 is readily absorbed through the skin, intestinal tract and lungs and distributed uniformly throughout the body. After absorption Clearlink 1000 is systemically available and it is expected to be extensively bioavailable.Accumulation is not expected to occur. Clearlink 1000 is likely to be excreted via feaces and urine.

Discussion on bioaccumulation potential result:

There is no valid experimental data available for the assessment of toxikokinetic behaviour of Clearlink 1000. The assessment has been made qualitatively on the basis of the physical and chemical properties and other relevant data available.

Adsorption: Clear signs of systemic toxicity (e.g. ataxia, body tremors and piloerection) have been reported after administration of test substance (trade name Clearlink 1000) in acute oral rat studies (section 7.2.1). Based on the results of these studies it can be concluded that Clearlink 1000absorbs from intestines. It is reasonable to assume, that Clearlink 1000 will also absorbs via airways, since that is the most delicate absorption route. Clear clinical signs of toxicity (e.g. lateral recumbency) were also observed in the acute dermal study in rats (section 7.2.3) and it can be concluded that Clearlink 1000 absorbs also through skin. Dose response of effects in acute oral and dermal studies can be seen as an indication of first-order kinetics in the absorption. However, the corrosive property of the substance is likely to enhance the penetration through skin and other body barriers.

Distribution:Clearlink 1000 is a lipophilic substance (log P = 1.31) with the molecular weight of 322.57 g/mol and only moderately soluble in water (section 4.8, 131 mg/L at approx. 23°C). It is likely to distribute into cells. CNS effects (ataxia, bode tremors, salivation etc.) reported in acute toxicity study by. J.O.Kuhn et al. 2001 indicate that Clearlink 1000 had distributed to CNS. Necropsy findings (discoloured lungs, liver, spleen and content of gastrointertinal tract) in the same study indicate that Clearlink 1000 has distributed to whole body. Clearlink 1000 is not likely to accumulate after frequent exposure (log P > 4). In a 28 -day repeated dose toxicity studies with the recovery period, clinical signs have resolved during the 14- or 28-day recovery period indicating that accumulation does not happen.

Metabolism: Following can be stipulated based on the structure of Clearlink 1000: Phase I reactions (oxidation, reduction and hydrolysis) are not likely to occur. Phase II metabolic reactions are conjugation reactions. The principle is to adda polar group, so the molecule becomes more water-soluble and can be excreted. These reactions are most likely to happen.

Excretion:The relative importance of the excretion depends on the physical and chemical properties of the compound and its various metabolites. Substances that are water soluble and have low molecular weight (below 300) are excreted via urine. Clearlink 1000 is moderately soluble in water and has a molecular weight over 300 therefore it is more likely to excrete via faeces.