Registration Dossier
Registration Dossier
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EC number: 264-120-7 | CAS number: 63393-96-4
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Only summary of data available but scientifically acceptable published data from an acknowledged source (EU Risk Assessment Report) (Data suitable for read-across).
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- European Union Risk Assessment Report dimethyldioctadecylammonium chloride
- Author:
- European Chemicals Bureau, Institute for Health and Consumer Protection
- Year:
- 2 002
- Reference Type:
- publication
- Title:
- Metabolism of cutaneously applied surfactants.
- Author:
- Drotman R.B.
- Year:
- 1 977
- Bibliographic source:
- Cutaneous Toxicity, 3, 95-109
Materials and methods
- Objective of study:
- absorption
- Principles of method if other than guideline:
- The 14C-labelled test substance was applied to the back of 4 rabbits. Radioactivity at the application site, in urine, faeces, exhaled carbon dioxide, other skin and cage wash was determined over a 72 hour period.
- GLP compliance:
- no
Test material
- Reference substance name:
- Dimethyldioctadecylammonium chloride
- EC Number:
- 203-508-2
- EC Name:
- Dimethyldioctadecylammonium chloride
- Cas Number:
- 107-64-2
- Molecular formula:
- C38H80N.Cl
- IUPAC Name:
- N,N-dimethyl-N-octadecyloctadecan-1-aminium chloride
- Details on test material:
- - Name of test material (as cited in study report): Dioctadecyldimethylammonium chloride (DODMAC)
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- not specified
- Details on exposure:
- TEST SITE
- Area of exposure: on the back, 5-8 cm area - Duration and frequency of treatment / exposure:
- single application
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10 mg
- No. of animals per sex per dose / concentration:
- 4
- Control animals:
- no
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, faeces, skin at the application site, other skin, cage washes, exhaled carbon dioxide
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Most of the radioactivity remained at the site of application (88 ± 2.3%).
- Details on distribution in tissues:
- Only traces of radioactivity were detected at other skin sites (0.2%).
- Details on excretion:
- Only traces of administered radioactivity were detected over a 72 h-period in urine (0.15 %), faeces (0.16 %), exhaled carbon dioxide (0.27 %) and cage wash (0.3%).
Metabolite characterisation studies
- Metabolites identified:
- not measured
Applicant's summary and conclusion
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