Registration Dossier
Registration Dossier
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EC number: 203-490-6 | CAS number: 107-43-7
Sensitisation data (human)
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:
- 1 996
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
- Reference Type:
- other: Patent
- Title:
- Unnamed
- Year:
- 2 000
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 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%).
Constituent 1
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.
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