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

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Dose descriptor:

NOAEL

100 mg/kg bw/day

Additional information

Discussion on read-across:

The result of a OECD 422 study has been read-across from Fatty acids, C18 unsaturated, reaction products with diethylenetriamine (also referred to as Tall oil diethylenetriamine imidazoline). This read-across substance is a starting material in the manufacture of Fatty acids, C18 unsaturated, reaction products with diethylenetriamine, acetate salts, which is a complex mixture of reaction products derived from the neutralisation of fatty acid-diethylenetriamine imidazoline (the read-across substance) with acetic acid. It is therefore considered that the results obtained from studies on Fatty acids, C18 unsaturated, reaction products with diethylenetriamine are suitable to read-across to and for use in the evaluation of Fatty acids, C18 unsaturated, reaction products with diethylenetriamine, acetate salts.

The below results for Tall oil diethylenetriamine imidazoline can be considered as a worst-case assessment for Fatty acids, C18 unsaturated, reaction products with diethylenetriamine, acetate salts. This is due to the expectation that the neutralisation of the Tall oil diethylenetriamine imidazoline to the acetate salts form would be anticipated to decrease the toxicity of the substance (if the neutralisation was to have any toxicological effect).

Tall oil diethylenetriamine imidazoline is corrosive to the skin (and presumed corrosive to the eyes).Fatty acids, C18 unsaturated, reaction products with diethylenetriamine, acetate salts is not corrosive to the skin, but is severly irritating and classified as a skin irritant. Therefore, the OECD 422 results obtained fromTall oil diethylenetriamine imidazoline may again represent a worst case assessment for the actetate salts form, as some of the effects seen in the study were effects due to the local irritancy/corrosivity of the tested substance and application of test substance, rather than true systemic effects. These effects could be anticipated to be descreased for the actetate salts.

Based on this information it was considered that in the interests of animal welfare, a OECD 422 study conducted using

Fatty acids, C18 unsaturated, reaction products with diethylenetriamine, acetate salts was not justified, and that the substances reproductive/developmental toxicity could be adequately assessed using the results obtained from a OECD 422 study conducted using Tall oil diethylenetriamine imidazoline, which are discussed below.

OECD 422 study withTall oil diethylenetriamine imidazoline:

A combined repeated dose/reproduction screening toxicity study according to OECD 422 has been performed withTall oil diethylenetriamine imidazoline. Dose levels consisted of 0, 10, 30 and 100 mg/kgbw/day.

Based on the increased incidence/severity of macrophage foci in the mesenteric lymph node at both the end of treatment and recovery period in males, a parental No Observed Adverse Effect Level (NOAEL) of 30 mg/kg/day was derived.

No reproductive/developmental toxicity was observed at any of the other dose levels and thus a reproduction/developmental NOAEL of 100 mg/kg/day was determined.

 

In view of the total lack of effects on reproduction in the performed reproduction toxicity screening study, a 2-generation study is not considered to provide useful additional information.

Short description of key information:
Results have been read-across from a suitable structural analogue substance, Fatty acids, C18 unsaturated, reaction products with diethylenetriamine (also referred to a Tall oil diethylenetriamine imidazoline).

NOAEL for reproduction/developmental of 100 mg/kg/day was established from a combined repeated dose/reproduction toxicity study with Tall oil diethylenetriamine imidazoline.

Effects on developmental toxicity

Description of key information

Results have been read-across from a suitable structural analogue substance, Fatty acids, C18 unsaturated, reaction products with diethylenetriamine (also referred to a Tall oil diethylenetriamine imidazoline).
No developmental toxicity was observed in an OECD 422 screening study with Tall oil diethylenetriamine imidazoline.

Effect on developmental toxicity: via oral route

Dose descriptor:

NOAEL

100 mg/kg bw/day

Additional information

No developmental toxicity was observed in an OECD 422 screening study with Tall oil diethylenetriamine imidazoline.

As OECD screening studies do not allow for a full developmental hazard evaluation, a full prenatal developmental toxicity study in rats according to OECD 414 is proposed for Tall oil diethylenetriamine imidazoline.

Justification for classification or non-classification

No reproductive/ developmental toxicity was observed in an OECD 422 screening study with Tall oil diethylenetriamine imidazoline.

Given that the toxicity of Fatty acids, C18 unsaturated, reaction products with diethylenetriamine, acetate salts, is not anticipated to be higher than that of Tall oil diethylenetriamine, it is considered that classification for reproductive/development toxicity is not required for the acetate salts.