Registration Dossier
Registration Dossier
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EC number: 947-701-6 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Under the retained experimental conditions Pine tar may be classified as sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30.5.-10.6.2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate attached in the study report
- Type of study:
- activation of keratinocytes
- Details on the study design:
- Cells seeding was performed on the first day. The preparation of the test item dilutions were conducted the following day. Test system included negative and postivi controls. According to protocol, contact between the cells and the test and reference items were made during the second day. The day four consisted Luciferace activity observations and cell viability assessment with MTT method.
- Positive control results:
- Positive controls showed results that are met in OECD validation dataset, between 7 µM and 30 µM.
- Key result
- Run / experiment:
- mean
- Parameter:
- other: viability / induction
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Under the retained experimental conditions Pine tar may be classified as sesitizer.
- Executive summary:
The pine tar was studied for sensitising properties using Keratinosens test. Under the retained experimental conditions Pine tar may be classified as sensitizer.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Under the retained experimental conditions Pine tar may be classified as sensitizer.
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