Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Multiple studies performed on humans studying the effect of betaine for improving skin and mu cous membrane health.

Data source

Referenceopen allclose all

Reference Type:
other: Patent
Title:
Unnamed
Year:
1996
Reference Type:
study report
Title:
Unnamed
Year:
1996
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996
Reference Type:
other: Patent
Title:
Unnamed
Year:
2000

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Multiple studies performed on humans studying the effect of betaine for improving skin and mucous membrane health.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Betaine, different products dissolved in various vehicles (purity >97%).

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: At least 5 humans per group, in most cases >10 humans
- Sex: male and female
Clinical history:
not reported
Route of administration:
dermal
Details on study design:
Various concentration ranges from 0-50% (w/v)of betaine in number of different vehicles.

Results and discussion

Results of examinations:
not sensitizing

Applicant's summary and conclusion

Conclusions:
Number of studies have been performed to study human sensitisation properties of betaine on the skin and mucous membrane. These studies were conducted in order to validate the anti-irritant properties of betaine for skin. These studies prove that betaine does not sensitize skin, rather improves skin health and works as an anti-irritant.
Executive summary:

Number of studies have been performed to study human sensitisation properties of betaine on the skin and mucous membrane. These studies were conducted in order to validate the anti-irritant properties of betaine for skin. These studies prove that betaine does not sensitize skin, rather improves skin health and works as an anti-irritant.