Registration Dossier
Registration Dossier
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EC number: 953-082-3 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Based on the available in vitro tests, valencene does not present a concern for genotoxic potential.
Link to relevant study records
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 487 (In vitro Mammalian Cell Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian cell micronucleus test
- Specific details on test material used for the study:
- Reported as: Valencene
- Species / strain / cell type:
- lymphocytes: Human peripheral blood lymphocytes
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 2000 µg/mL in the presence and absence of metabolic activation for 3 and 24 hours.
- Vehicle / solvent:
- dimethyl formamide (DMF)
- Species / strain:
- lymphocytes: Human peripheral blood lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Reported as: Valencene
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 5000 µg/plate
- Vehicle / solvent:
- dimethyl sulfoxide (DMSO)
- Details on test system and experimental conditions:
- - Test substance added in agar (plate incorporation)
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Endpoint:
- genetic toxicity in vitro, other
- Remarks:
- Cytotoxicity and genotoxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: BlueScreen assay
- GLP compliance:
- yes
- Type of assay:
- other: High-throughput gene reporter assay - measures increased transcription of GADD45-alpha
- Specific details on test material used for the study:
- Reported as: Valencene
- Target gene:
- GADD45-alpha
- Species / strain / cell type:
- other: Gaussia
- Species / strain:
- other: Gaussia
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Based on the available in vitro data, valencene does not present a concern for genotoxic portntial. Therefore, valencene does not meet the CLP (EC 1272/2008) criteria for classification for germ cell mutagenicity.
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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