Registration Dossier
Registration Dossier
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EC number: 948-032-2 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05. Jun. 2018 31. Oct. 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- Terpene Dimers
- EC Number:
- 948-032-2
- IUPAC Name:
- Terpene Dimers
- Test material form:
- liquid
- Details on test material:
- Batch no. DF1710011
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: Human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test system is a commercially available EpiDermTM-Kit, procured by MatTek. The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers representing main lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell culture inserts.
Origin: EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.
Designation of the kit: EPI-200-SIT
Day of delivery: 12. Jun. 2018
Batch no.: 28623 - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 30 µl
- Duration of treatment / exposure:
- 1 hour
- Duration of post-treatment incubation (if applicable):
- 23 hours
- Number of replicates:
- 3 for negative control
1 for positive control
1 for treatment
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- treatment
- Value:
- 74.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The mean value of relative tissue viability of the test item was reduced to 74.1 % after the treatment. This value is above the threshold for skin irritation (50%). Therefore, the test item is considered as non-irritant to skin.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- All validity criteria were met. Values for negative control and for positive control were within the range of historical data of the test facility. Therefore, the experiment is considered valid. The test item is considered as non-irritant to skin.
- Executive summary:
One valid experiment was performed. Three tissues of the human skin model EpiDermTM were treated with Terpene Dimers for 60 minutes. The test item was applied directly to each tissue and spread to match the tissue size (0.63 cm2; as indicated by the supplier). DPBS-buffer was used as negative control and 5% SDS solution was used as positive control. After treatment with the negative control, the mean absorbance value was within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 1.5. The positive control showed clear irritating effects. The mean value of relative tissue viability was reduced to 2.8 % (required: ≤ 20%). The variation within the tissue replicates of negative control, positive control and test item was acceptable (required: ≤ 18%). After the treatment with the test item, the mean value of relative tissue viability was reduced to 74.1 %. This value is above the threshold for skin irritation potential (50%). Test items that induce values above the threshold of 50% are considered non- irritant to skin.
Therefore, Terpene Dimers is considered non- irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
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