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Toxicological information

Basic toxicokinetics

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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

Referenceopen allclose all

Reference Type:
secondary source
Title:
Unnamed
Year:
2007
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

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%.