GHS Classification Guidance for the Japanese Government

Fig. 3-2 Workflow for classification of Germ Cell Mutagenicity in GHS
(The number for each test corresponds to that of test in Table 3-8.)
Does the substance have positive data
from human heritable epidemiological
studies?
Does the substance have positive data
from the in vivo heritable germ cell
mutagenicity test (1)?
Does the substance have positive data
from the in vivo germ cell mutagenicity
test (2)?
Does the substance have positive data
from the in vivo somatic cell
mutagenicity test (3)?
Does the substance have negative data from the tests (1)
to (3) except for (4)?
Does the substance have positive
data from the in vivo somatic or
germ cells genotoxicity tests (4, 5)?
Does the substance have positive
results of multiple indexes from the
In vitro mutagenicity test (6)?
: Yes : No
*The substance is determined as “Category 2” or “Classification not possible”
Overall, the validity of each set of data should be considered, and the substance is judged based on
the weight of evidence.
Does the substance have
positive data from the in vivo
genotoxicity test (4) ?
Does the substance have
positive data from the In
vitro mutanogenecity test
(6)?
Seek for expert's
judgment as needed
151
Category1A
Category 1B
Category 1B
Category 1B
Category 2
Not classified
Classification not
possible
Category 2/ Classification
not possible *
Classification not
possible