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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 December 2021
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Enzymatically produced steviol glycosides
- IUPAC Name:
- Enzymatically produced steviol glycosides
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Initial Test : 1 Male
Confirmatory Test : 2 Males
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- distilled water
- Amount / concentration applied:
- 0.5 g of test item moistened with 0.5 mL of distilled water was applied.
- Duration of treatment / exposure:
- In the initial test, 0.5 g of test item moistened with 0.5 mL of distilled water was applied for 3 minutes, 1 hour and 4 hours respectively.
In the confirmatory test, the patches were applied for 4 hours exposure period. - Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Clinical Signs of Toxicity and Mortality
No clinical signs of toxicity and mortality were observed in any of the animals in initial test and confirmatory test.
Dermal Evaluations
No skin reactions like erythema and oedema were observed in any of the animals in initial test and confirmatory test.
Body Weight
No treatment related changes were observed in body weight and percent change in body weight with respect to day 1 in initial test and confirmatory test animals. All animals revealed normal increase in the body weight during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the experiment, it is concluded that single dermal application of Enzymatically Produced Steviol Glycosides did not reveal any skin reactions when applied to the skin of New Zealand White Rabbits, hence the test item is considered as non-irritant and did not meet the classification criteria according to the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals.
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.
