GHS Classification Guidance for the Japanese Government

that the relevant information sources are the latest available.
2) When there is no data in List 1:
a) Among data collected from other information sources (for example, information
sources shown in List 2), data considered to be reliable (GLP-conforming data or data
whose evidence are specified and assessed) are adopted. When there is hesitation
about decision, judgement by expert’s shall be sought for where necessary.
b) In that case, it should be confirmed that assessment documents and database used are
the latest available or that references cited are reliable.
c) Among data which experts judged to be reliable to a certain extent, the safer data (i.e.,
the smallest concentration for aquatic environment hazards, the highest value for
bioaccumulation, the smallest value for rapid degradability) shall be finally adopted.
However, when four or more data sets are available for the same life stage, condition,
and test period of the same species, their geometric mean shall be adopted as the
representative data of the species.
D) Comparison with conventional classification systems
The definitions of EU classification are almost in accord with GHS categories.
R50: Very toxic to aquatic organisms.
R51: Toxic to aquatic organisms.
R52: Harmful to aquatic organisms.
R53: May cause long-term adverse effects in the aquatic environment.
Based on the four relevant R-Phrase 11 above, the following categories may be estimated.
Category: Acute 1 =EU･R50(and R50/53)
Category: Acute 2 =EU･R51(and R51/53)
Category: Acute 3 =EU･R52(and R52/53)
Category: Chronic 1 ≒EU･R50/53
Category: Chronic 2 ≒EU･R51/53
Category: Chronic 3 ≒EU･R52/53
The definitions of R50, 51, and 52 correspond with that of Acute 1, Acute 2, and Acute 3 of
GHS classification, respectively. However, the former is different from the latter in that
Crustacea is limited to Daphnia, and that the testing time for algae is fixed at 72 hours. The
requirement for R53 is log Kow≥3.0 or BCF>100, and is slightly wider than that in GHS
classification. Moreover, test data serving as evidence are not sufficiently published, and some
of them appear to be determined based on structure-action relationship or data of analogous
substances. Accordingly, its data on biodegradability and bioaccumulation should be confirmed.
11 For R-Phrase, see Appendix.
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