Registration Dossier

Diss Factsheets

Administrative data

Description of key information

An in vitro study (THP-1 cells, Acute Monocytic Leukema) is available to evaluate the skin sensitizing potenial fo Centella asiatica dry ext.

Centella asiatica dry ext. resulted not sensitizing.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
other: KIMBER 2001
GLP compliance:
yes
Type of study:
other: THP-1 cells, Acute Monocytic Leukema
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
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Centella asiatica dry ext. is not classified as skin sensitizer.

Categories Display