Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
