Reaction products of stearic acid with 2-aminoethanol, maleic anhydride and sodium sulphite

Endpoint summary

Link to relevant study record(s)

Reference

Endpoint:

basic toxicokinetics, other

Remarks:

Please refer to Toxicokinetics Assessment under the Endpoint Summary section.

Type of information:

other: A preliminary assessment of toxicokinetic properties was made based on the information currently available from the present dataset. The information does not result from a toxicokinetic study so the minimum fields required cannot be filled in.

Adequacy of study:

other information

Description of key information

The available experimental data in animals did not show any clear evidence of absorption and systemic distribution of the test substance and/or its metabolites or degradation products through the oral and dermal routes up to the limit dose tested. There was also no indication of metabolic alteration based on the available in vivo and in vitro studies. No specific indication on the test substance excretion was obtained from the toxicity studies.

Key value for chemical safety assessment

Bioaccumulation potential:

no bioaccumulation potential

Additional information

No specific toxicokinetic studies are available on the registered substance. A toxicokinetic assessment was made based on the physico-chemical properties of the test substance and the results of toxicity studies (acute oral toxicity, skin sensitisation,in vitrogenotoxicity studies and repeated dose toxicity study).

Physico-chemical properties :

Molecular weight: Approximately 445 g/mol

Water solubility: 0.257 μg/L (at 20°C)

Partition coefficient in octanol/water: - 1.6 (at 20°C)

Vapour pressure: 4.2 x 10^-3Pa (at 25°C)

Absorption and distribution :

Oral:

In the acute oral toxicity study, no mortality nor clinical signs indicative of systemic toxicity were reported in rats exposed to one single oral (gavage) administration of Sopromine 1686 up to the limit dose of 2000 mg/kg bw.

In the OECD 422 rat study, there was no test item related mortality and the only clinical signs reported consisted in transient ptyalism after treatment noted at all dose levels in males with dose-related incidence and in females from 300 mg/kg/day. There was no effect on body weight and food consumption, no macroscopic and no microscopic findings at any dose level up to the top dose of 1000 mg/kg/day. Only slight variations of no toxicological significance were reported in some clinical pathology parameters.

Dermal route:

In the in vivo skin sensitization test (LLNA) performed in mouse, no mortality nor signs of systemic toxicity were reported in any animals. Slight but not toxicologically significant body weight losses were observed in each treatment group. Based on this study, there was no evidence that the registered substance is able to pass the dermal barrier to encounter the systemic circulation.

Overall, there are no obvious evidences of distribution of the registered substance by the oral or dermal route.

Metabolism:

No specific toxicological effects indicative of metabolic alteration were observed in the acute and repeated dose toxicity studies in rodents.

The outcome of the in vitro genotoxicity tests (Ames test, Mouse Lymphoma Assay and micronucleus test) was not affected by the presence of metabolic activation. The tests showed no obvious mutagenic or clastogenic effects in the presence or in the absence of exogenous liver S9 metabolization system.

Elimination

There is no indication of a preferred route of excretion for the registered substance.