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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Well designed and executed study to investigate percutaneous absorption (permeation potential) of betaine in vitro using Franz chambers with freshly isolated human epidermis (abdominal skin). Betaine exhibited extremely low (<0,1%) percutaneous absorption roperties.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Deviations:
- yes
- Remarks:
- only one dose (5%) was used as duplicate, intead of series but two different vehicles were used
- 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:
- Betafin BP20; batch #4310539075; BB date 6.9.2009) and betaine emulsion ("Kosteusvoide 1.3.2007")
Constituent 1
Test animals
- Species:
- other: Human freshly isolated abdominal epidermis
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- other: In vitro: Franz chambers (donor/receiver)
- Vehicle:
- physiological saline
- Remarks:
- or emulsion
- Duration of exposure:
- 24 hours
Results and discussion
- Absorption in different matrices:
- Percutaneous permeation of betaine was extremely low. Less than 0.1 % of the initial dose applied a top the skin permeated through the skin regardless of the formulation.
Applicant's summary and conclusion
- Conclusions:
- 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.
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.
