Docosyltrimethylammonium methyl sulphate

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Only short abstract available - Only secondary literature. For justification for read-across see chapter 1 of the chemical safety report.

Data source

Reference

Reference 1

Reference Type:

secondary source

Title:

Unnamed

Year:

2007

Reference 2

Reference Type:

secondary source

Title:

Unnamed

Year:

1996

Materials and methods

Objective of study:

toxicokinetics

Principles of method if other than guideline:

Absorption, distribution, metabolism and excretion of Didecyldimethyl ammonium chloride was measured in rats

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Didecyldimethylammonium chloride

EC Number:

230-525-2

EC Name:

Didecyldimethylammonium chloride

Cas Number:

7173-51-5

IUPAC Name:

N-decyl-N,N-dimethyldecan-1-aminium chloride

Details on test material:

- Name of test material (as cited in study report): didecyldimethyl ammonium chloride

Radiolabelling:

yes

Remarks:

14-C-didecyldimethyl ammonium chloride

Test animals

Species:

rat

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on exposure:

VEHICLE
- Concentration in vehicle: 40% in water

Duration and frequency of treatment / exposure:

single dose

Doses / concentrations

Remarks:

Doses / Concentrations:
a) 5 mg/kg
b) repeated 34 ppm in diet of cold didecyldimethyl ammonium chloride for 14 d, then 5 mg/kg
c) 50 mg/kg

No. of animals per sex per dose / concentration:

5

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:

The majority (>90% ) of the orally administered dose was excreted very likely unabsorbed via the faeces. From the amount excreted in urine (<3%) and tissue residues (<1%), the report authors concluded that the oral absorption was <10%.

Details on excretion:

Excretion primarily via feces (89-99%) and urine (2.5%); an insignificant amount was expired.

Metabolite characterisation studies

Details on metabolites:

The majority (>90% )of the orally administered dose was excreted very likely unabsorbed via the faeces. From the amount excreted in urine (<3%) and tissue residues (<1%), the report authors concluded that the oral absorption was <10%.
Excretion primarily via feces (89-99%) and urine (2.5%); an insignificant amount was expired.
Metabolites were characterised from dose group c) using TLC, HPLC and MS. Females metabolised the parent compound more than males. Metabolism, which may be by microbial activity, comprised the oxidation of the two decyl side chains to form hydroxy and hydroxyketo derivatives; metabolism of methyl side chains was not found.

Applicant's summary and conclusion

Conclusions:

In a toxicokinetic study, rats received a single oral gavage dose of 14C-labelled didecyldimethyl ammonium chloride. The majority (>90% )of the administered dose was excreted via the faeces. From the amount excreted in urine (<3%) and tissue residues (<1%), the report authors concluded that the oral absorption was less than 10%.