Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Rapporteur for the EU risk assessment of (3-chloro-2-hydroxypropyl)trimethylammonium chloride is the National Product Control Agency for Welfare and Health, Finland. The report is the result of in-depth work performed by experts in one Member State, working with counterparts in other Member States, Industry and public interest groups. The information reported is considered reliable.

Data source

Reference
Reference Type:
other: Published secondary source
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Details of the guideline followed not given
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Radiolabelling:
yes

Results and discussion

Applicant's summary and conclusion

Conclusions:
The percutaneous absorption of (3-chloro-2-hydroxypropyl)trimethylammonium chloride was examined in a study which used a 2-14C radiolabelled test substance and viable human and mouse skin membranes. The tests were conducted using four concentrations : 0.1, 1, 20 and 65% (3-chloro-2-hydroxypropyl)trimethylammonium chloride. 14C testostrone was used as the reference compound. The amount of test substance in the receptor fluid and the residual (3-chloro-2-hydroxypropyl)trimethylammonium chloride remaining in the skin and the stratum corneum 48-h post exposure were determined. In the viable human skin membranes, the amount of radioactivity in the skin after tape stripping was between 0.5 and 6.8 fold higher than the amount in the receptor fluid. The amount found in stratum corneum was between 1.1 to 21 times higher than what was found in the receptor fluid. In mouse skin, the amount of radioactivity in skin after tape stripping was 5.3 to 17.6 times lower than the amount of radioactivity in the receptor fluid. The mean recovery of radioactivity was between 91.2 and 102.2% in mouse and human skin membranes. Based on the findings in the in-vitro skin penetration assay, a maximum penetration rate of 0.685% was reached in the human skin.
Executive summary:

The percutaneous absorption of (3-chloro-2-hydroxypropyl)trimethylammonium chloride was examined in a study which used a 2-14C radiolabelled test substance and viable human and mouse skin membranes. The tests were conducted using four concentrations : 0.1, 1, 20 and 65% (3-chloro-2-hydroxypropyl)trimethylammonium chloride. 14C testostrone was used as the reference compound. The amount of test substance in the receptor fluid and the residual (3-chloro-2-hydroxypropyl)trimethylammonium chloride remaining in the skin and the stratum corneum 48-h post exposure were determined. In the viable human skin membranes, the amount of radioactivity in the skin after tape stripping was between 0.5 and 6.8 fold higher than the amount in the receptor fluid. The amount found in stratum corneum was between 1.1 to 21 times higher than what was found in the receptor fluid. In mouse skin, the amount of radioactivity in skin after tape stripping was 5.3 to 17.6 times lower than the amount of radioactivity in the receptor fluid. The mean recovery of radioactivity was between 91.2 and 102.2% in mouse and human skin membranes. Based on the findings in the in-vitro skin penetration assay, a maximum penetration rate of 0.685% was reached in the human skin. [Source : European Union Risk Assessment Report for (3-Chloro-2-hydroxypropyl)trimethylammonium Chloride, 2008].