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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
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)
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

Results and discussion

In vitro / in chemico

Resultsopen allclose all
Key result
Parameter:
other: Positive Control (PC) (Cinnamic aldehyde) induction > o igual 1.5-fold in at least one concentration
Run / experiment:
Mean of the 3 repetitions
Value:
ca. 1.518
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
1.518 at 8 microM 2.664 at 16 microM 5.019 at 32 microM 11.866 at 64 microM 20.861 at 128 microM
Key result
Parameter:
other: Average induction of PC at 32 microM is 1.6-3.0
Run / experiment:
Mean of the 3 repetitions
Value:
ca. 5.02
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: All other aceptance criteria are met, and there is dose-dependent increase of induction with the Positive Control therefore, the results are considered as valid
Key result
Parameter:
other: EC1.5 value is 6-39 microM
Run / experiment:
Mean of the 3 repetitions
Value:
ca. 7.87
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Parameter:
other: CV% of blank values < 20%
Run / experiment:
Mean of the 3 repetitions
Value:
ca. 15.73
Negative controls validity:
not valid
Positive controls validity:
not valid

Applicant's summary and conclusion

Interpretation of results:
other: The result of the KeratinoSens skin sensitisation assessment of Cloruro Del Acido was Positive
Conclusions:
The result of the KeratinoSens skin sensitisation assessment of Cloruro Del Acido was Positive