Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Genetic toxicity in vitro:

In vitro gene mutation in bacteria: Weight of evidence: Experimental results from independent sources and read-across. Camphene was not mutagenic in all strains/cell types with and without metabolic activation.

 

In vitro cytogenicity study in mammalian cells: Key study: read-across from analogues. Read-across analysis shows that Camphene is negative against chromosomal aberrations with and without S9.

In vitro mammalian gene mutation study: Key study: Camphene, technical grade, solid did not induce gene mutations in presence and absence of metabolic activation in cultured mammalian cells (L5178Y/TK+/- 3.7.2 C mouse lymphoma cell line) used.

In vitro gene mutation study in mammalian cells: Supporting study: read-across from analogue. Read-across analysis shows that Camphene is negative for the in vitro gene mutation assay in mammalian cells, with and without S9.

 

Genetic toxicity in vivo: Key study: Camphene was not mutagenic in the micronucleus test (mice).Test method was according to OECD guideline 474.


Short description of key information:
Genetic toxicity in vitro:
In vitro gene mutation in bacteria: Weight of evidence: Experimental results from independent sources and read-across. Camphene was not mutagenic in all strains/cell types with and without metabolic activation.

In vitro cytogenicity study in mammalian cells: Key study: read-across from analogues. Read-across analysis shows that Camphene is negative against chromosomal aberrations with and without S9.
In vitro mammalian gene mutation study: Key study: Camphene, technical grade, solid did not induce gene mutations in presence and absence of metabolic activation in the cultured mammalian cells (L5178Y/TK+/- 3.7.2 C mouse lymphoma cell line) used.

In vitro gene mutation study in mammalian cells: Supporting study: read-across from analogue. Read-across analysis shows that Camphene is negative for the in vitro gene mutation assay in mammalian cells, with and without S9.

Genetic toxicity in vivo: Key study: Camphene was not mutagenic in the micronucleus test (mice). Test method was according to OECD guideline 474.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the results obtained in the in vitro and in vivo studies, the substance is not classified.