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Key value for chemical safety assessment

Additional information

(-)-beta-Pinene was tested in a reverse gene mutation assay in bacteria, performed according to OECD guideline 471 and in compliance with GLP, in S. typhimurium strains (TA 1535, TA 1537, TA 1538, TA 98, TA 100), either with or without metabolic activation. The results were negative.

The results of a gene mutation test (HPRT) in CHO cells were also negative. (-)-beta-Pinene was tested with and without metabolic activation. The study was performed according to OECD guideline 476 and in compliance with GLP.

In a gene mutation assay in mouse lymphoma L5178Y TK+/- cells, inconclusive results for mutagenicity were obtained for (-)-beta-pinene: in an old evaluation, it was positive without metabolic activation and negative with metabolic activation whereas, in a more recent study, it was negative without metabolic activation and gave ambiguous results with metabolic activation.

The results of an in vitro SCE in CHO cells and a Ames test (in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 1538) carried out with beta-pinene were also negative.

Delta-3-carene was tested in a reverse gene mutation assay in bacteria, performed according to OECD guideline 471 and in compliance with GLP, in S. typhimurium strains (TA 1535, TA 1537, TA 98, TA 100, TA 102), either with or without metabolic activation. The results were negative.

Urinary metabolites of alpha-pinene in rats were also found negative in TA 98 and TA 100 with metabolic activation. Negative results were obtained with alpha-pinene in vitro in UDS performed in rat hepatocytes and in an in vivo micronucleus assay performed on peripheral erythrocytes of mice exposed for 90 days by inhalation. The results obtained in TA 98, TA 100, TA 1535, TA 1537, TA 1538 and E. coli WP2 uvr A- pKM 101, with and without metabolic activation, were also negative.

The results of three recent GLP in vitro studies conducted according to OECD guidelines 471, 473 and 476 with crude sulphate turpentine were also negative. Turpentine oil was found negative in TA98, TA 100 and TA 102, with and without metabolic activation.

Negative results were obtained with camphene in an in vivo micronucleus assay performed on bone marrow of rats exposed once by oral route, and in TA 98, TA 100, strains UTH8414 and UTH8413 (having full DNA repair system), with and without metabolic activation.

There is no requirement to conduct additional genotoxicity tests with (-)-beta-pinene, as negative results were obtained in appropriate test systems.


Short description of key information:
Negative results were obtained with (-)-beta-pinene in two in vitro mutagenicity studies (Ames test and HPRT test) and inconclusive results for mutagenicity were obtained in a mouse lymphoma L5178Y TK+/- cells assay. The result of an in vitro SCE in CHO cells carried out with beta-pinene was also negative.

This was confirmed by studies carried out on structurally related substances. Negative results were obtained with alpha-pinene, delta-3-carene, turpentine oil and camphene in several Ames tests. Urinary metabolites of alpha-pinene in rats were also found negative in TA 98 and TA 100 with metabolic activation.
Negative results were obtained with alpha-pinene in vitro in UDS performed in rat hepatocytes and in an in vivo micronucleus assay performed on peripheral erythrocytes of mice exposed for 90 days by inhalation. The results of three recent GLP in vitro studies conducted according to OECD guidelines 471, 473 and 476 with crude sulphate turpentine were also negative. Negative results were obtained with camphenein an in vivo micronucleus assay performed on bone marrow of rats exposed once by oral route.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The results of the in vitro and the in vivo tests were negative. Based on these studies, (-)-beta-pinene is not expected to induce heritable mutations in germ cells and is therefore not classified for mutagenicity/genotoxicity according to Directive 67/548/EEC and CLP Regulation (EC) No 1272 /2008.