Registration Dossier
Registration Dossier
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EC number: 305-105-8 | CAS number: 94334-32-4 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Thuya plicata, Cupressaceae.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 march 2017 to 29 march 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- yes
- Remarks:
- It must be noted that the certificate of analysis supplied by the sponsor is not a GLP document.
- GLP compliance:
- yes
- Remarks:
- GLP certificate in annex 1 of the final report
Test material
- Reference substance name:
- Thuya plicata, ext.
- EC Number:
- 305-105-8
- EC Name:
- Thuya plicata, ext.
- Cas Number:
- 94334-32-4
- Molecular formula:
- not relevant as a UVCB substance
- IUPAC Name:
- Water steam distillation of needles and twigs of Thuya plicata
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- other: Reconstructed human epidermis
- Cell type:
- other:
- Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- after a treatment of 3 min and 1 hour (see annexes 2 and 3 of the final report)
- Duration of treatment / exposure:
- 3 minutes at room temperature and 1 hour at 37°C +/- 1°C
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- dose of 50 µL
- Duration of treatment / exposure:
- 3 minutes and 1 hour
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- skin 7
- Value:
- 104.32
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- skin 8
- Value:
- 99.14
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Test item does not have to be classified in category 1 as skin corrosive.
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