Registration Dossier
Registration Dossier
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EC number: 290-166-2 | CAS number: 90082-75-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Pinus pinaster, Pinaceae.
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Several in vitro genetic toxicity data were available on the main components of Pinus pinaster oil: Carene-3-delta and Pinene alpha and beta. Carene-3 -delta and pinenes (alpha and beta) are bicyclomonoterpen molecules, are very similar in structure and have the same toxicity profile regarding the genetic toxicity potential.
A weight of evidence of all the available data was therefore followed to complete the 7.6.1 endpoint.
Four Ames tests were available on delta-3 -carene, alpha and beta pinenes and were all negative. All the tests were performed with and without metabolic activation and were negative in both metabolic conditions. The bacterial strains tested in the four tests included: S. tiphymurium TA1535, TA1537, TA1538, TA98, TA100, TA102 and E. coli WP2. Therefore all the strains mandatory by the REACh regulation were tested.
An UDS test was also available on alpha pinene. The assay was performed in vitro on rat hepatocyte and gave negative results.
It can be therefore considered that Pinus pinaster oil is not mutagenic in bacteria and in mammalian cells based on data on its main components.
Justification for selection of genetic toxicity endpoint
A weight of evidence strategy was followed to complete the endpoint requirements.
Short description of key information:
Negative Ames and UDS tests performed on delta-3-carene alpha and beta pinenes, the main components of the Pinus pinaster oil.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Harmonized classification:
Pinus pinaster oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Based on the data available, Pinus pinaster oil is not classified as genotoxic
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