Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: SNIF file released by ECHA
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Objective of study:
other: To examine the skin penetration of a 5% (w/w) formulation of the test substance after a single application
Test guideline
Qualifier:
according to
Guideline:
other: Penetration through human epidermis in vitro
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Radiolabelling:
no

Test animals

Species:
other: Samples of human epidermis

Administration / exposure

Route of administration:
dermal
Vehicle:
other: 5% test substance in a sunscreening product formulation
Details on exposure:
Methods of administration or exposure : Placed on the skin samples
Control animals:
no

Results and discussion

Metabolite characterisation studies

Metabolites identified:
not measured

Any other information on results incl. tables

Approx. 0.1% (= approx. 0.05 ug/cm2) at the high dose (10 mg of the preparation/cm2) and approx. 1.3% (= approx 0.065 ug/cm2) at the low dose (1 mg of the preparation/cm2) have penetrated the epidermis 24 hours after application.

Applicant's summary and conclusion