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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
Reference substance name:
Betaine
EC Number:
203-490-6
EC Name:
Betaine
Cas Number:
107-43-7
Molecular formula:
C5H11NO2
IUPAC Name:
(trimethylammonio)acetate
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.