Reaction mass of L-Glutamic acid, N-coco acyl derivs., monosodium salts and sodium hydrogen N-(1-oxooctadecyl)-L-glutamate

Endpoint summary

Key value for chemical safety assessment

Bioaccumulation potential:

no bioaccumulation potential

Absorption rate - oral (%):

100

Absorption rate - dermal (%):

25

Absorption rate - inhalation (%):

100

Additional information

Introduction

Reaction Mass of L-Glutamic acid, N-coco acyl derivatives, monosodium salts and sodium hydrogen N-(1-oxooctadecyl)-L-glutamate (EC Number: 915-656-1) is an UVCB substance. Physico-chemical properties of Reaction Mass of L-Glutamic acid, N-coco acyl derivatives, monosodium salts and sodium hydrogen N-(1-oxooctadecyl)-L-glutamate, together with QSAR assessments and the results of in vitro and in vivo studies that were conducted with the substance or with a related, read-across substance (Reaction mass of sodium hydrogen N-(1-oxooctadecyl)-L-glutamate and sodium hydrogen N-(1-oxohexadecyl)-L-glutamate; EC Number 936-610-7) have been used to determine, as far as possible, a toxicokinetic profile for Reaction Mass of L-Glutamic acid, N-coco acyl derivatives, monosodium salts and sodium hydrogen N-(1-oxooctadecyl)-L-glutamate.

Physicochemical properties

Reaction Mass of L-Glutamic acid, N-coco acyl derivatives, monosodium salts and sodium hydrogen N-(1-oxooctadecyl)-L-glutamate is a UVCB (organic). This multi-constituent substance contains approximately 55% of the read across substance Reaction mass of sodium hydrogen N-(1-oxooctadecyl)-L-glutamate and sodium hydrogen N-(1-oxohexadecyl)-L-glutamate. It is a white to pale yellow powder at room temperature with a melting point in the region of 188°C. Its relative density and vapour pressure at 20°C are 0.453 to 0.562 g/cm³and 0.00044 Pa, respectively. The median mass aerodynamic diameter (MMAD) and D₅₀are 45.275 µm and <60.367 µm respectively. The partition coefficient (log Kow/Pow, 25°C) was estimated to be 3.27, 0.24 or 2.2 for Sodium hydrogen N-(1-oxooctadecyl)-L-glutamate, 2, LGlutamic acid, N-coco acyl derivs., monosodium salts (17 carbon atoms) or 2, L-Glutamic acid, N-coco acyl derivs., monosodium salts (21 carbon atoms) respectively. It is soluble in water at 5 mg/mL at 20°C.

Absorption

Oral absorption

In acute oral toxicity tests in mice (with Reaction Mass of L-Glutamic acid, N-coco acyl derivatives, monosodium salts and sodium hydrogen N-(1-oxooctadecyl)-L-glutamate) and rats (with the read across substance) the LD₅₀values were reported to be >2000 mg/kg. No signs of toxicity, mortality or gross necropsy findings were seen in either study.

Although no information on oral absorption can be inferred from the acute toxicity tests, the nature of the substance would suggest good oral absorption. The substance is water soluble and moderately lipophilc, favouring absorption by passive diffusion, although metabolism by intestinal flora can be expected to occur, as supported by biodegradation data.

Based on the organic nature of the components within the substance, and the fact that more than 50% of its composition is the read across substance, Reaction mass of sodium hydrogen N-(1-oxooctadecyl)-L-glutamate and sodium hydrogen N-(1-oxohexadecyl)-L-glutamate, complete oral absorption could be expected. Therefore, 100% oral absorption will be used for human health risk assessment purposes.

Dermal absorption

The read-across substance,Reaction mass of sodium hydrogen N-(1-oxooctadecyl)-L-glutamate and sodium hydrogen N-(1-oxohexadecyl)-L-glutamate, is not acutely toxic via dermal exposure (LD₅₀>2000 mg/kg bw), nor is it corrosive or irritating to skin and it is not a skin sensitizer.

Reaction Mass of L-Glutamic acid, N-coco acyl derivatives, monosodium salts and sodium hydrogen N-(1-oxooctadecyl)-L-glutamate is somewhat soluble in water with moderate lipophilicity and therefore some degree of dermal absorption would be expected to may occur. Therefore, in the absence of any quantitative data and in line with the EC guidance on dermal absorption (EFSA Panel on Plant Protection Products and their Residues (PPR); Guidance on Dermal Absorption. EFSA Journal 2012;10(4):2665), 25% dermal absorption will be used for human health risk assessment purposes. This dermal absorption estimate is considered highly protective, given that the substance is a solid and, according to the latest version of the same guidance on dermal absorption (EFSA, Buist H, Craig P, Dewhurst I, Hougaard Bennekou S, Kneuer C, Machera K, Pieper C, Court Marques D, Guillot G, Ruffo F and Chiusolo A, 2017. Guidance on dermal absorption. EFSA Journal 2017;15(6):4873) the default value would be 10%.

Inhalation absorption

No data are available for acute inhalation toxicity with either the substance or the read across substance. However, given the particle size of Reaction Mass of L-Glutamic acid, N-coco acyl derivatives, monosodium salts and sodium hydrogen N-(1-oxooctadecyl)-L-glutamate inhalation of particles is feasible and its water solubility and log P of its components would favour passive diffusion across the respiratory tract epithelium.

 

Therefore, in the absence of any other information and for the purposes of human DNEL setting, 100% inhalation absorption is assumed for human health risk assessment purposes.

Distribution, Metabolism and Elimination

No in vivo information is available to describe the distribution, metabolism or elimination ofReaction Mass of L-Glutamic acid, N-coco acyl derivatives, monosodium salts and sodium hydrogen N-(1-oxooctadecyl)-L-glutamate. However, given its organic nature, it is expected that once absorbed the components of the substance will be widely distributed within the body and metabolised to substrates of endogenous metabolism. The acyl residues will be distributed via chylomicrons, while glutamic acid will reach the liver, and there subjected to metabolism or re-used for other metabolic processes.

The acyl residues and glutamate will be used as a source of energy within the citric acid cycle; in case of glutamate, it will be also used for the synthesis of peptides or other amino acids, or excreted in the form of urea.

Bioaccumulation is considered unlikely to occur.

Conclusions

Based on the available data for Reaction Mass of L-Glutamic acid, N-coco acyl derivatives, monosodium salts and sodium hydrogen N-(1-oxooctadecyl)-L-glutamate, oral absorption is estimated at 100%, inhalation absorption is estimated at 100% and dermal absorption is estimated at 25%.

There is no potential for bioaccumulation.