Registration Dossier

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
skin obtained from plastic surgery from multiple donors
Source strain:
other: human-derived epidermal keratinocytes
Control samples:
yes, concurrent negative control
yes, concurrent positive control

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other: Absorbance Values
Run / experiment:
Tissue 1, Measurement 1
Value:
1.008
Negative controls validity:
valid
Remarks:
1.239
Positive controls validity:
valid
Remarks:
0.083
Irritation / corrosion parameter:
other: Absorbance Values
Run / experiment:
Tissue 1, Measurement 2
Value:
1.023
Negative controls validity:
valid
Remarks:
1.259
Positive controls validity:
valid
Remarks:
0.084
Irritation / corrosion parameter:
other: Absorbance Values
Run / experiment:
Tissue 2, Measurement 1
Value:
1.014
Negative controls validity:
valid
Remarks:
1.321
Positive controls validity:
valid
Remarks:
0.088
Irritation / corrosion parameter:
other: Absorbance Values
Run / experiment:
Tissue 2, Measurement 2
Value:
1.022
Negative controls validity:
valid
Remarks:
1.340
Positive controls validity:
valid
Remarks:
0.089
Irritation / corrosion parameter:
other: Absorbance Values
Run / experiment:
Tissue 3, Measurement 1
Value:
0.786
Negative controls validity:
valid
Remarks:
1.099
Positive controls validity:
valid
Remarks:
0.089
Irritation / corrosion parameter:
other: Absorbance Values
Run / experiment:
Tissue 3, Measurement 2
Value:
0.808
Negative controls validity:
valid
Remarks:
1.103
Positive controls validity:
valid
Remarks:
0.088
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
tissue 1
Value:
82.3
Positive controls validity:
valid
Remarks:
3.9%
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
tissue 2
Value:
82.4
Positive controls validity:
valid
Remarks:
4.3%
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
tissue 3
Value:
63.8
Positive controls validity:
valid
Remarks:
4.3
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
mean
Value:
76.2
Positive controls validity:
valid
Remarks:
4.1%

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item [3R-(3α, 3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-6-ol (Cedrol) is considered as non-irritant to skin.
After the treatment, the mean value of relative tissue viability was reduced to 76.2%. This value is above the threshold for skin irritation (50%).
The optical density of the negative control was well within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8.
The positive control has met the acceptance criterion too, for thus ensuring the validity of the test system.
Variation within replicates was within the accepted range for negative control, positive control and test item (required: ≤ 18%).
For these reasons, the result of the test is considered valid.