Kaur-16-en-18-oic acid, 13-[(O-β-D-glucopyranosyl-(1.fwdarw.2)-O-[β-D-glucopyranosyl-(1.fwdarw.3)]-β-D-glucopyranosyl)oxy]-, β-D-glucopyranosyl ester, (4α)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 02, 2021

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Some time points of temperature deviated from the study plan during the test. The biggest deviated values of temperature was 24.7℃.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl (1R,4S,5R,9S,10R,13S)-13-{[(2S,3R,4S,5R,6R)-5-hydroxy-6-(hydroxymethyl)-3,4-bis({[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy})oxan-2-yl]oxy}-5,9-dimethyl-14-methylidenetetracyclo[11.2.1.0¹,¹⁰.0⁴,⁹]hexadecane-5-carboxylate

EC Number:

611-696-6

Cas Number:

58543-16-1

Molecular formula:

C44H70O23

IUPAC Name:

(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl (1R,4S,5R,9S,10R,13S)-13-{[(2S,3R,4S,5R,6R)-5-hydroxy-6-(hydroxymethyl)-3,4-bis({[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy})oxan-2-yl]oxy}-5,9-dimethyl-14-methylidenetetracyclo[11.2.1.0¹,¹⁰.0⁴,⁹]hexadecane-5-carboxylate

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

other: Japanese White (Albino rabbit)

Test system

Preparation of test site:

clipped

Vehicle:

water

Remarks:

Purified water (Fresh prepared)

Amount / concentration applied:

0.5 g of test item was weighed and added to 0.4 ml of vehicle, and then was applied.

Duration of treatment / exposure:

4 hours

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 1100, 1101, 1102

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: 1100, 1101, 1101

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 Observations
No abnormal signs or symptoms were observed in three animals throughout the course of the study.

Skin Reactions Examination
There were no observable abnormalities for the three control sites at all observation intervals.
There were no observable abnormalities for the three treated sites at all observation intervals.

Grading of Skin Reactions
The scores of erythema/eschar and oedemas of all the animals at approximately 1, 24, 48 and 72 hours observation points were all 0 after patches removal of the test item.
The mean scores of erythema/eschar and oedemas of all the animals at 24, 48 and 72 hours observation points were all 0 after patches removal of the test item.

Body Weights
The animals showed expected gains in body weights during the course of study.

 

Animal ID	Sex	Dose (g/animal)	Observation Time (following patch removal)
			Day 0	Day 1	Day 2	Day 3
1100	Male	0.5	N	N	N	N
1101	Male	0.5	N	N	N	N
1102	Male	0.5	N	N	N	N

Note: N = No observable abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on above results, Rebaudioside A is considered to have no irritation to skins in rabbits, and was classified as “unclassified” according to GHS’s classification criteria for the skin irritation.