Fatty acids, C18-unsatd., reaction products with diethylenetriamine, acetates

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

other: In accordance with REACH Annex VIII (8.8.1) an assessment of toxicokinetic behavior has been conducted to the extent that can be derived from the relevant available information.

Adequacy of study:

key study

Study period:

Assessment conducted May 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Relevant studies were reviewed by a qualified toxicologist with a view to fulfilling the requirements of Annex VIII (8.8.1). All data reviewed and evaluated for the purposes of the assessment of toxicokinetic behaviour, including studies on the read-across substance, were studies of a reliability rating of 1 (done to a valid guideline, without deficiencies affecting the quality of result and conducted to GLP conditions) or valid QSAR data. Therefore, as the assessment was based on reliable study and QSAR data, rather than second hand literature data, it is considerd appropriate that the toxicokinetic assessment can also be viewed as reliability 1.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Objective of study:

toxicokinetics

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

In accordance with REACH Annex VIII (8.8.1) an assessment of toxicokinetic behaviour has been conducted to the extent that can be derived from the relevant available information. The assessment is based on the Guidance on information requirements and chemical safety assessment R.7c: Endpoint specific guidance (ECHA, May 2008)

GLP compliance:

no

Remarks:

Not relevant for assessment

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C18 unsaturated, reaction products with diethylenetriamine, acetate salts

EC Number:

938-649-5

Cas Number:

1469982-92-0

Molecular formula:

Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)

IUPAC Name:

Fatty acids, C18 unsaturated, reaction products with diethylenetriamine, acetate salts

Details on test material:

Details on the test material used in the studies assessed are presented in the respective endpoint study records.

Results and discussion

Any other information on results incl. tables

TOXICOKINETIC BEHAVIOUR

The substance is composed as in IUCLID section 1.2 (Composition). It is a brown extremely viscous liquid and the molecular weight is 283 - 734 g/mol.

The low vapour pressurevalue(1.23 x 10^-25to 3.96 x 10^-16 Pa at 25°C)and predicted negative explosive and oxidising properties shows that the substance is non volatile therefore inhalation is not a significant route of exposure.

The substance has a low log octanol/water partition coefficient value (Log₁₀Pow 2.29) and low water solubility (1.6 x 10^-11g/l to fully miscible at 25°C).

Based upon read across to a study performed upon a comparable substance (Tall oil diethylenetriamine imidazoline) there is evidence to suggest absorption but no indication of metabolism or route of elimination.

The test item was non-mutagenic in bacteria, non-clastogenic (based on read-across data on Tall oil diethylenetriamine imidazoline) in mammalian cells in vitro and non-mutagenic in mammalian cells (based on read-across data on Tall oil diethylenetriamine imidazoline) in vitro in either the absence or presence of an auxiliary metabolising system.

Absorption

Results of the acute oral study and the supporting evidence of the repeated dose reproductive screening study with a structurally similar product (Tall oil diethylenetriamine imidazoline) showed evidence to support the gastric absorption of the test item. This would suggest that the gastro-intestinal tract provides a route of absorption, following oral administration, before entering the circulatory system via the blood. The small molecular size of the substance may allow absorption through passive diffusion.

The substance is corrosive and there is evidence of dermal irritation. The test item is also considered to be a skin sensitizer. Therefore damage to the skin surface may allow for increased penetration of the substance through the skin.

The low vapour pressure value (1.23 x 10^-25 to 3.96 x 10^-16 Pa at 25°C) shows that the substance is not available as a vapour therefore inhalation is not a significant route of exposure.

Distribution

The positive response in a skin sensitisation study suggests that the test item may bind to carrier proteins in the circulatory systems, thereby facilitating systemic distribution.

Metabolism

The results of the reproductive screening study with a structurally similar product (Tall oil diethylenetriamine imidazoline)

did not show evidence to indicate any test item influenced hepatic metabolism. The results of the genotoxicity assays have shown that genotoxicity is neither enhanced or diminished in the presence of the S9 metabolising system.

 

Excretion

There is no evidence to indicate the route of excretion but poorly water-soluble products are not favourable for urinary excretion and therefore biliary excretion may well be a significant route for this material. Any test item that is not absorbed will be excreted in the faeces.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): other: See summary in conclusions section
The available information suggests that absorption of the test substance from the gastrointestinal tract can take place. Some absorption may also take place via the skin. Biliary excretion may well be significant route for the substance. There is no evidence to suggest that the test substance may be metabolised, however no studies have been conducted to identify metabolites. The primary route of excretion could not be established from available data.

Executive summary:

The available information suggests that the substance is readily available via the oral route; however absorption via the skin is also possible. This is supported by the physicochemical properties of the substance. There is no evidence to indicate the route of excretion.