Registration Dossier
Registration Dossier
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EC number: 268-071-2 | CAS number: 68002-58-4 This substance is identified by SDA Substance Name: C14-C18 dialkyl dimethyl ammonium methyl sulfate and SDA Reporting Number: 17-049-00.
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Ref. 6.2 (2) in: Inclusion of active substances in Annex I to Directive 98/8/EC - Draft Assessment Report - Didecyldimethylammonium chloride - Product-type 8 (Wood preservative) - Rapporteur Member State: Italy
- Author:
- RMS Italy
- Year:
- 2 008
- Bibliographic source:
- http://circa.europa.eu/Public/irc/env/bio_reports/library?l=/review_programme/ca_reports/wood_preservatives/published_10102007&vm=detailed&sb=Title
- Reference Type:
- secondary source
- Title:
- SUMMARY OF TOXICOLOGY DATA DIDECYLDIMETHYLAMMONIUMCHLORIDE
- Author:
- CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY, DEPARTMENT OF PESTICIDE REGULATION, MEDICAL TOXICOLOGY BRANCH
- Year:
- 1 996
- Bibliographic source:
- http://www.cdpr.ca.gov/docs/risk/toxsums/pdfs/1682.pdf
- Reference Type:
- publication
- Title:
- A review of the environmental impact and toxic effects of DDAC
- Author:
- Henderson ND
- Year:
- 1 992
- Bibliographic source:
- BC Enviroment, Canada
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
- 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
Constituent 1
- 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%.
Under the test conditions, the test material (containing carbon 14 labelled DDAC) showed a low absorption after oral administration. It is excreted in the urine and faeces and a negligible amount is retained in the body after 1 wk
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