Registration Dossier
Registration Dossier
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EC number: 202-956-6 | CAS number: 101-58-6
Endpoint summary
Administrative data
Description of key information
Determination of Skin Irritation Potential of bis(4-(1,1,3,3-tetramethylbutyl)phenyl) ether in the Reconstructed Human Epidermis (RhE) Test Method following OECD Guideline 439 And EU-Method B.46
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04.May2020 - 08.May2020
Study Report: June 29, 2020 - Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: MatTek In Vitro Life Science Laboratories, Bratislava
- Justification for test system used:
- Reconstructed human Epidermis (RhE) Test Method
- Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- 30 µl
- Duration of treatment / exposure:
- 60 minutes
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- > 109.6 - < 111.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- non-irritant to human skin
- Executive summary:
3 tissues of the human skin model EpiDerm were treated with the test item for 60 minutes. The test item was applied directly to each tissue and spread to match the tissue size of 0,63 cm².
After treatment with the negative control, the mean adsorbance value was within the required acceptability criterion of 0.8 mean OD 2.8, OD was 1.7. The positive control showed clear irritating effects: The mean value of relative tissue viability was reduced to 2,9 % (required: 20%).
The variation within the tissue replicates of negative control, positive control and test item was acceptable (required: 18 %). After treatment with the test item, the mean value of relative tissue viability was 109.0 %. This value is above the threshold for skin irritation potential (50 %).
Therefore the test item, Bis(4-(1,1,3,3-tetramethylbutyl)phenyl) ether is considered non-irritant to skin in the Reconstructed human Epidermis (RhE) Test Methlod.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
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