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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Some time points of the temperature in animal room (the highest value was 26.1℃) were deviated from the study plan.
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
an appropriate Buehler test is available

Test material

Constituent 1
Chemical structure
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

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.2 g
Day(s)/duration:
On Day 0 (first induction date), Day 7 and Day 14
Adequacy of induction:
other: For no irritation was found in the preliminary irritation test, about 0.2g test item was directly selected for both induction and challenging.
Challenge
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.2 g
Day(s)/duration:
On day 28
Adequacy of challenge:
other: For no irritation was found in the preliminary irritation test, about 0.2g test item was directly selected for both induction and challenging.
No. of animals per dose:
Preliminary irritation group (2 animals): 32,4
Control group (10 animals): 28,1,26,14,21,11,17,18,16,6
Treated group (20 animals): 8,24,25,31,3,2,22,13,30,9,10,19,15,27,29,12,20,7,5,23
Positive control substance(s):
yes
Remarks:
Name：α-Hexylcinnamaldehyde Molecular formula：C15H20O Molecular weight：216.32 g/mol CAS No.：101-86-0

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.2g (moistened with 0.4ml purified water)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No visible change in skin reactions (erythema and / or swelling) were found on the right treated skin of each animal in the control animals and treated animals observed at 24h and 48h observation after the patch was removed and the scores were all 0.
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.2g (moistened with 0.4ml purified water)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No visible change in skin reactions (erythema and / or swelling) were found on the right treated skin of each animal in the control animals and treated animals observed at 24h and 48h observation after the patch was removed and the scores were all 0.
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
no data
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Severity index=0, Incidence=0%
Remarks on result:
other: Group: Control
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
no data
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Severity index=0, Incidence=0%
Remarks on result:
other: Group: Control
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
no data
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
Severity index=0.35, Incidence=30%
Remarks on result:
other: Group: Treated
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
no data
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
Severity index=0.35, Incidence=30%
Remarks on result:
other: Group: Treated
Group:
negative control
Remarks on result:
not measured/tested

Any other information on results incl. tables

13.1 Preliminary test phase
No visible change in skin reactions were found on the treated skin area of each animal observed in the morning of the next day. So about 0.2g test item (moistened with 0.4ml purified water)was used in the induction phase and about 0.2g test item (moistened with 0.4ml purified water) were used in the challenge phase.


13.2 Induction phase
No visible change in skin reactions (erythema and / or swelling) were found on the treated skin during the first, second and third induction phases at 24h and 48h observation after the patch was removed and the scores were all 0.


13.3 Challenge phase
No visible change in skin reactions (erythema and / or swelling) were found on the right treated skin of each animal in the control animals and treated animals observed at 24h and 48h observation after the patch was removed and the scores were all 0.


The incidence of skin sensitisation was 0% and the severity index was 0 at 24h and 48h.


13.4 Body weight
The animals weighed on the receiving day, the day before first dosing day and at the conclusion of the study. The mean body weight of the treatment and control group showed an increasing trend and not affected by the test item.


13.5 Moribundity and mortality observation
No moribundity or deaths were found during the whole test period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on above results, Rebaudioside A is not a skin sensitizer to Guinea pigs. The results do not meet the GHS classification criteria for skin sensitisation (Buehler method).