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Administrative data

Endpoint:
skin sensitisation, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: KIMBER 2001
GLP compliance:
yes
Type of study:
other: THP-1 cells, Acute Monocytic Leukema

Test material

Constituent 1
Reference substance name:
Hydrocotyle asiatica, ext.
EC Number:
283-640-5
EC Name:
Hydrocotyle asiatica, ext.
Cas Number:
84696-21-9
Molecular formula:
not applicable
IUPAC Name:
Hydrocotyle asiatica, ext.
Test material form:
solid

Results and discussion

In vitro / in chemico

Resultsopen allclose all
Key result
Run / experiment:
other: 1: 100 microg/mL
Parameter:
other: Optical density
Value:
1.84
Negative controls validity:
valid
Key result
Run / experiment:
other: 2: 100 microg/mL
Parameter:
other: Optical density
Value:
1.91
Negative controls validity:
valid
Key result
Run / experiment:
other: 3: 100 microg/mL
Parameter:
other: Optical density
Value:
2.071
Negative controls validity:
valid
Key result
Run / experiment:
other: 4: 10 microg/mL
Parameter:
other: Optical density
Value:
2.505
Negative controls validity:
valid
Key result
Run / experiment:
other: 5: 10 microg/mL
Parameter:
other: Optical density
Value:
2.012
Negative controls validity:
valid
Key result
Run / experiment:
other: 6: 10 microg/mL
Parameter:
other: Optical density
Value:
2.168
Negative controls validity:
valid
Key result
Run / experiment:
other: 7: 1 microg/mL
Parameter:
other: Optical density
Value:
2.642
Negative controls validity:
valid
Key result
Run / experiment:
other: 8: 1 microg/mL
Parameter:
other: Optical density
Value:
2.386
Negative controls validity:
valid
Key result
Run / experiment:
other: 9: 1 microg/mL
Parameter:
other: Optical density
Value:
2.363
Negative controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Centella extract at the concentration of 100 microg / mL is not sensitizing.
Due to the fast cellular growth of the THP-1 seeded for MTT test, the optical density of the wells treated with centella 1-10 micro/g mL were out of the accepted range (0-2 OD) and have not been considered.

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