Registration Dossier

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:
2002
Reference Type:
publication
Title:
Metabolism of cutaneously applied surfactants.
Author:
Drotman R.B.
Year:
1977
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dioctadecyldimethylammonium chloride (DODMAC)
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:
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