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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 OCT 1991 to 25 OCT 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
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, >95% purity (product name: natural extract AP, lot no: 60125225)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino
Test system
- Vehicle:
- water
- Remarks:
- 10% w/v solution
- Controls:
- other: The untreated eye served as control.
- Amount / concentration applied:
- 0.1 mL of 10% solution
- Duration of treatment / exposure:
- single dose
- Observation period (in vivo):
- 1, 24, 48, and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Animals were examined under a standard light source designed to comply with the requirements of BS 950 Part 1 (Artificial Daylight for the Assessment of Colour). The eyes were assessed for damage or irritation to the cornea, iris and conjunctiva using the untreated eye as a control.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- No signs of irritation or corneal or iridial lesions were observed in any of the animals throughout the 72-hour observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The application of betaine (natural extract AP, 10% w/v in distilled water) did not result in any ocular irritation, and it can be considered non-irritant at the concentration used in this study.
- Executive summary:
Betaine was tested in an in vivo eye irritation study according to OECD guideline 405. The application of betaine (natural extract AP, 10% w/v in distilled water) did not result in any ocular irritation, and it can be considered non-irritant at the concentration used in this study.
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.
