2,3-epoxypropyltrimethylammonium chloride

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

other: EU Risk Assessment report

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Although the EU risk assessment report is secondary literature, all data and risk assessment for the human, health and the environment have been evaluated and reviewed by Finland prior to publication. The risk assessment report has been submitted to final approval and published in the Official Journal of the European Union C157/10 dated on 21.06.2008. Thus, it is considered the information reported are reliable with the restrictions that reliability of the data presented has not been assessed again.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

European Union Risk Assessment 2,3-epoxypropyltrimethylammonium chloride CAS RN 3033-77-0 Einecs No: 221-221-0

Author:

EC

Year:

2008

Bibliographic source:

Risk Assessment. Final approved version. Rapporteur: Finland (FIN). European communities. Printed in Italy. 147pp

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

2,3-epoxypropyltrimethylammonium chloride

EC Number:

221-221-0

EC Name:

2,3-epoxypropyltrimethylammonium chloride

Cas Number:

3033-77-0

Molecular formula:

C6H14NO.Cl

IUPAC Name:

N,N,N-trimethyl(oxiran-2-yl)methanaminium chloride

Applicant's summary and conclusion

Executive summary:

Basic physico-chemical characteristics are available, which can be used to estimate toxicokinetic behaviour. The molecular size of EPTAC is relatively small (MW 151.5 g/mol), which can be a facilitating factor in absorption through membranes. Dermal absorption

through passive diffusion could be expected to be low because the molecule is charged. Data from toxicological tests show that at least some absorption occurs via the gastro-intestinal (GI) tract and skin. Being a small molecule, it is possible that EPTAC pass through G-I tract membranes by passive penetration through aqueous pores at the tight junction. Findings from acute dermal toxicity data indicate that absorption occurs via the dermal route. More importantly, an in vitro skin penetration study is available for 3 -chlorohydroxypropyltrimethylammonium chloride (CAS 3327 -22 -8) (CHPTAC), a substance which has a closely related molecular structure. This allows also the assessment of the skin penetration properties of EPTAC. EPTAC can enter lungs as a residue in cationised starch dust. Theoretically, EPTAC could enter lungs also in water solution as aerosol particles. Depending on the particle size various parts of the respiratory system could be affected. The majority of big (> 10 μm) dust particles would probably stay in the nasopharyngeal mucous membranes. Therefore, the residual EPTAC could dissolve in the mucus and be directly absorbed to blood circulation or it could be carried to the pharynx where it might enter the gastrointestinal tract. Smaller (<1 μm) particles could enter the tracheobronchial or alveolar space of the lungs where the substance could be released and enter the blood or be removed by the lymph circulation.

Distribution of EPTAC from vascular space to extracellular or intracellular compartment is probably slow due to the poor membrane passing quality. It may be possible for EPTAC to pass from the vascular space to the extracellular or intracellular compartment via aqueous pores. Entrance into fat is expected to be slow because of the low lipid/water partition coefficient [log Pow = -1.23].

Because EPTAC has a highly electrophilic epoxy group the metabolism is likely to occur mainly in the liver either via hydrolysis by an epoxide hydrolase or phase 2 enzymes, viz. different conjugation reactions such as glutathione S-transferases. These hydrophilic products are normally excreted effectively into urine.