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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
activation of keratinocytes

Test material

Constituent 1
Chemical structure
Reference substance name:
E-N'-{2-cyano-4-[3-(2-hydroxy-1,1-dimethylethyl)-thioureido]-phenyl}-N,N-dimethylformamidine
Cas Number:
1429755-57-6
Molecular formula:
C15H12N5OS
IUPAC Name:
E-N'-{2-cyano-4-[3-(2-hydroxy-1,1-dimethylethyl)-thioureido]-phenyl}-N,N-dimethylformamidine

Results and discussion

In vitro / in chemico

Results
Key result
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

ARE-Nrf2 Luciferase Test (KeratinoSens™) – Results summary

Study Number: SQ46WL

Test Date: 13 August 2020

SPS 5290 Stage 3 Results

Test item conc. (µM)

0.98

1.95

3.91

7.81

15.63

31.25

62.5

125

250

500

1000

2000

Mean fold induction

0.78

0.81

3.76

1.02

1.02

0.92

1.08

1.19

1.63

2.21

3.40

9.24

Statistically significant

N/A

N/A

Yes

N/A

N/A

N/A

N/A

N/A

Yes

Yes

Yes

Yes

Viability (%)

115.80

105.40

108.22

99.99

99.27

101.07

93.85

90.68

104.03

93.78

91.76

38.41

Imax

9.24

 

EC1.5(µM)

214.03

IC30(µM)

1407.83

IC50(µM)

1782.70

Determination criteria for the skin sensitisation potential of the test item

Result

Is the Imax≥1.5 fold and statistically significant

Yes

Is the cellular viability >70% at the EC1.5determining concentration

Yes

Is the EC1.5value <1000 µM

Yes

Is there a dose-response increase for luciferase induction

Yes

KeratinoSens™ prediction

Positive

 

 

Positive Control (cinnamic aldehyde) Results

Positive control conc. (µM)

4

8

16

32

64

Mean fold induction

1.15

4.79

2.66

2.79

7.67

Statistically significant

N/A

Yes

Yes

Yes

Yes

Viability (%)

90.60

104.18

85.48

95.66

44.90

Imax

7.67

 

EC1.5(µM)

4.39

IC30(µM)

N/A

IC50(µM)

N/A

 

Test Acceptance Criteria

Result

Luciferase activity induction obtained with the positive control statistically significant above the threshold of 1.5 in at least one of the test concentrations

Yes

Pass

Average induction of positive control at 64 µM between 2 – 8

Yes (7.67)

Pass

EC1.5of positive control within two standard deviations of the historical mean (‑2.36 to 28.67)

Yes (4.39)

Pass

CV% of blank values < 20%

No (32.3%)

Fail

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
After 48h exposure of cells with 12 concentrations of the test item, Luciferase measurements and MTT viability testing were performed.
The test item was classified as Positive according to the KeratinoSens prediction model.