Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from NOV 19 2006 to FEB 4 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Well designed and executed study for percutaneous absorption (permeation potential) of betaine in vitro using Franz chambers with freshly isolated human epidermis (abdominal skin). This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: OECD 428
Deviations:
yes
Remarks:
only one dose (5%) was used as duplicate, intead of series but two different vehicles were used.
Principles of method if other than guideline:
Franz chambers: donor and receiver chamber filled with PBS. Atop betaine (5% in saline or emulsion, pH7.4. Completely solubilized) was applied, samples were withdrawn from receiver chamber at appropriate intervals and analysed.
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

Test system

Type of coverage:
other: In vitro: Franz chambers (donor/receiver)
Preparation of test site:
other: In vitro: freshly isolated human epidermis clamped between cell halves
Vehicle:
physiological saline
Remarks:
or emulsion
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period:
1,2,4,6,8,11 and 24 hours
Number of animals:
in vitro

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: percutaneous permeation/absorption (in vitro diffusion study using Franz chambers) at 1, 2, 4, 6, 8, 11 and 24 hours
Value:
ca. 0
Remarks on result:
other:
Remarks:
extremely low permeation, 0,1% of the initial dose regardless of formulation
Other effects / acceptance of results:
Percutaneous permeation of betaine was extremely low. Less than 0.1 % of the initial dose applied atop the skin permeated through the skin regardless of the formulation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was tested for percutaneous absorption using Franz chambers with a protocol similar to OECD guideline 428. The test was designed and performed adequately. 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.