Registration Dossier
Registration Dossier
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EC number: 295-619-8 | CAS number: 92113-15-0
Endpoint summary
Administrative data
Description of key information
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
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of keratinocytes
- Specific details on test material used for the study:
- Oil-rich hop extract, batch no. BI/YYF/1701
- Key result
- Parameter:
- other: Prediction of sensitisation potential
- 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:
- Together with endpoints 002 and 003, hop extract is classified as a sensitiser to human skin. The study performed on hop extract is relevant for tetrahydroisoalpha acids, since these are derived from hop extract.
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of keratinocytes
- Specific details on test material used for the study:
- Low oil hop extract, batch no. 871 008
- Key result
- Parameter:
- other: Prediction of sensitisation potential
- 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:
- Together with endpoints 002 and 003, hop extract is classified as a sensitiser to human skin. The study performed on hop extract is relevant for tetrahydroisoalpha acids, since these are derived from hop extract.
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
- Specific details on test material used for the study:
- Low oil hop extract, batch no. 871 008
- Key result
- Parameter:
- other: Prediction of sensitisation potential
- 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:
- Together with endpoints 002 and 003, hop extract is classified as a sensitiser to human skin. The study performed on hop extract is relevant for tetrahydroisoalpha acids, since these are derived from hop extract.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Justification for classification or non-classification
The study performed on hop extract is relevant for beta acids, since hop extract may contain up to ca. 64% beta acids. Three in vitro tests, OECD 442D for and oil-rich hop extract, and OECD 442D and OECD 442C for a low-oil hop extract, all indicate skin sensitisation potential. Therefore hop extract should be classified as a skin sensitiser.
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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