Registration Dossier

Administrative data

Endpoint:
dermal absorption in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Well designed and executed study to investigate percutaneous absorption (permeation potential) of betaine in vitro using Franz chambers with freshly isolated human epidermis (abdominal skin). Betaine exhibited extremely low (<0,1%) percutaneous absorption roperties.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 428 (Skin Absorption: In Vitro Method)
Deviations:
yes
Remarks:
only one dose (5%) was used as duplicate, intead of series but two different vehicles were used
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Betafin BP20; batch #4310539075; BB date 6.9.2009) and betaine emulsion ("Kosteusvoide 1.3.2007")

Test animals

Species:
other: Human freshly isolated abdominal epidermis
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
other: In vitro: Franz chambers (donor/receiver)
Vehicle:
physiological saline
Remarks:
or emulsion
Duration of exposure:
24 hours

Results and discussion

Absorption in different matrices:
Percutaneous permeation of betaine was extremely low. Less than 0.1 % of the initial dose applied a top the skin permeated through the skin regardless of the formulation.

Applicant's summary and conclusion

Conclusions:
The result show that the test substance has an extremely low percutaneous permeation capability.
Executive summary:

The test substance was tested for percutaneous absorption using Franz chambers with a protocol similar to OECD guideline 428. The results showed that betaine has an extremely low percutaneous permeation capability (0.1% of the initial dose regardless of formulation). Therefore, the test substance considered not irritating under the conditions of this test.