Registration Dossier
Registration Dossier
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EC number: 289-964-3 | CAS number: 90045-98-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Simmondsia chinensis N., Buxaceae.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Reference substance name:
- Jojoba Esters
- Cas Number:
- 61789-91-1
- IUPAC Name:
- Jojoba Esters
- Reference substance name:
- Alcohols, C14-22 and C16-22-unsatd.
- EC Number:
- 268-107-7
- EC Name:
- Alcohols, C14-22 and C16-22-unsatd.
- Cas Number:
- 68002-95-9
- IUPAC Name:
- Alcohols, C14-22 and C16-22 unsaturated
- Reference substance name:
- Fatty acids, C14-22 and C16-22-unsatd., potassium salts
- EC Number:
- 286-079-4
- EC Name:
- Fatty acids, C14-22 and C16-22-unsatd., potassium salts
- Cas Number:
- 85186-93-2
- IUPAC Name:
- Fatty acids, C14-22 and C16-22 unsaturated, potassium salts
- Test material form:
- semi-solid (amorphous): gel
Constituent 1
Constituent 2
Constituent 3
Constituent 4
- Specific details on test material used for the study:
- batch SC21C31A-
25 μL of deionized water is added to ensure a good contact of the sample with the skin surface and 25 mg of the undiluted test substance is applied on the top of each tissue for 60 ± 5 minutes
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Ready-to-use, highly differentiated 3D tissue model consisting of normal, human-derived epidermal keratinocytes (NHEK) cultured on specially prepared tissue culture inserts at an air-liquid interface.
- Vehicle:
- water
- Details on test system:
- EPIDERM™ MATTEK LOT. 34179
Ready-to-use, highly differentiated 3D tissue model consisting of normal, human-derived epidermal keratinocytes (NHEK) cultured on specially prepared tissue culture inserts at an air liquid interface - Control samples:
- yes, concurrent positive control
- Amount/concentration applied:
- 25 μL of deionized water is added to ensure a good contact of the sample with the skin surface and 25 mg of the undiluted test substance is applied on the top of each tissue for 60 ± 5 minutes
- Duration of treatment / exposure:
- 1 hour
- Number of replicates:
- Test is performed in triplicate: 3 wells per test substance, 3 for positive control and 3 for negative control for each experimental condition
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- >= 99.31 - <= 105.65
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The Test material is not a skin irritant
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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