Registration Dossier
Registration Dossier
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EC number: 201-035-6 | CAS number: 77-53-2
Skin irritation / corrosion
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:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [3R-(3α,3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-6-ol
- EC Number:
- 201-035-6
- EC Name:
- [3R-(3α,3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-6-ol
- Cas Number:
- 77-53-2
- Molecular formula:
- C15H26O
- IUPAC Name:
- [3R-(3α,3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-6-ol
- Test material form:
- solid: particulate/powder
Constituent 1
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.
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