Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

The substance has been tested for acute toxicity by oral and dermal exposure, for subacute (28 d) toxicity by oral
application, for skin and eye irritation and for skin sensitization. In addition, a screening test for toxicity to reproduction and developmental toxicity has been performed. Moreover, three in-vitro tests for mutagenicity have been performed, without any relevance for the toxicokinetic behaviour of the substance.

ACUTE TOXICITY

In the test for the acute oral toxicity in rats, the substance has been applied at dose levels of 2000 mg/kg body
weight and 5000 mg/kg body weight. No mortality could be observed. No clinical signs, indicating a resorbtion and/or
toxicity of the substance, could be observed.
Dermal application of 2000 mg/kg body weight did not lead to any mortality. No systemic effects could be observed that
would indicate any resorbtion and/or toxicity of the substance.

REPEATED DOSE TOXICITY

In the 28-day toxicity study in rats, the substance was applied at dose levels of 50, 200 and 1000 mg/kg/day.

The dose levels in the screening study for toxicity to reproduction were 100, 300 and 1000 mg/kg/day.
No significant signs of systemic effects, indicating an intestinal resorption, were observed.


SKIN AND EYE IRRITATION

In the skin and eye irritation study and in the skin sensitization study, the application of the substance did
not lead to any local or systemic effects.

OTHER LOCAL EFFECTS

The test item did not induce any local effects in any study performed, either skin and eye irritation tests nor any test for acute or repeated dose toxicity.


CONCLUSION

All other available results do not lead to any indication of the toxicokinetic behaviour of the substance.

Presumably, the substance was not resorbed or showed no toxicity when resorbed. The assumption that the test item is not resorbed is supported by the both the molecular weight as well as the molecular size of the test item.

Since the test item is a UVCB substance containing various molecules with alkyl chains of different length, the average molecular diameters, as specified in the TGD on data requirements and chemical safety assessment, appendix R.11-1 annex 2, of the test item containing two C10 (component I), two C12 (component II), and two C14 alkyl chains (component III) have been determined using the Chem3D Pro software. Average molecular diameters as well as molecular weights are summarised in the following table.

Parameter Component I  Component II  Component III 
Mol formula  C46H68N6O6  C50H76N6O6  C54H84N6O6
Mol weight [g/mol]  801.1  857.2  913.3
Dmax aver [nm]  3.75  3.66  4.33

Substances with a molecular weight > 700 g/mol and a molecular diameter of > 1.7 nm are considered to be incapable of passing biological membranes according to the TGD on data requirements and chemical safety assessment, appendix R.11-1 annex 2

. As can be seen from the table, all representative molecular species present in the test item do fulfil these criteria. Therefore, the test item is considered to be non bioavailable.