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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 December 2021
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2022

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Enzymatically produced steviol glycosides
IUPAC Name:
Enzymatically produced steviol glycosides
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Batch No.: 20200901
Content: 100%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL (Initial test: 60.2 mg and Confirmatory test: 57.4 mg and 59.2 mg)
Duration of treatment / exposure:
Each animal was dosed once. The eye was rinsed using 0.9% w/v normal saline after 1 hour treatment (post treatment).
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0

Any other information on results incl. tables

No treatment related clinical signs of toxicity and mortality were observed in all the animals (initial and confirmatory tests) after the test item instillation.


In both initial and confirmatory test, treated eye (left) revealed occular lesions like redness at 1 hour observation. The observed lesion reversed back to normal by 24 hour observation.


In both initial and confirmatory test, no ocular lesion was observed at 24 hour observation during slit lamp examination.


No changes were noted in body weight and percent change in body weight with respect to day 1 in both initial and confirmatory test. All the animals revealed physiologically normal increase in body weight in both initial and confirmatory tests.


For initial test and confirmatory test, the mean score calculated across 3 scoring times (approximately 24, 48 and 72 hours after test item instillation) for cornea, iris and conjunctival redness and conjunctival chemosis were 0, 0, 0 and 0 respectively.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the above results of the experiment and under the experimental conditions employed, it is concluded that the mean score of the test item Enzymatically Produced Steviol Glycosides did not meet classification criteria and hence not classified or categorized as per the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).