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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Mai 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
Version / remarks:
February 04, 2015
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
activation of keratinocytes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
batch no. 182-72-2

Results and discussion

In vitro / in chemico

Resultsopen allclose all
Key result
Parameter:
other: luciferase induction
Run / experiment:
first experiment
Value:
< 1.5
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Key result
Parameter:
other: luciferase induction
Run / experiment:
second experiment
Value:
< 1.5
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

In the first and second experiments, nosignificant luciferase induction > 1.5 was found in the tested concentration range. Therefore, no EC1.5value could be calculated. Under the condition of this study the test item is therefore considered as non sensitiser.