GHS Classification Guidance for the Japanese Government
GHS Classification Guidance for the Japanese Government
GHS Classification Guidance for the Japanese Government
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
decision, judgement by expert’s shall be sought <strong>for</strong> a final decision.<br />
For individual species, see below. As <strong>for</strong> data in List 1 without indication of<br />
accordance with <strong>the</strong> test guidelines below and o<strong>the</strong>r relevant criteria, such data shall be<br />
adopted in which organism species, exposure time, and endpoint each accord with those<br />
stipulated in <strong>the</strong> test guidelines and o<strong>the</strong>r relevant criteria.<br />
■ Fish:<br />
Chronic or long-term toxicity tests using fish shall be conducted according to OECD<br />
Test Guideline 210 (Fish early life stage test), Fish Life Cycle Test(US EPA 850.1500), or<br />
corresponding test methods(one- or two-generation test). Although OECD Test Guideline<br />
210 is designed <strong>for</strong> sub-chronic toxicity, its test results may be utilized as indexes of<br />
chronic aquatic toxicity since <strong>the</strong>y provide good indexes <strong>for</strong> chronic toxicity, .<br />
The appendix to OECD Test guideline 210 defines exposure time <strong>for</strong> each species (<strong>for</strong><br />
example, <strong>the</strong> case of Oryziatidae, up to 30 days (at minimum 28 days) after hatching),<br />
while a Fish Life Cycle Test(US EPA850.1500) provides no definition on <strong>the</strong> duration.<br />
Accordingly, <strong>for</strong> data requiring confirmed reliability, <strong>the</strong> exposure time adopted is<br />
considered to be appropriate if <strong>the</strong> compliance to OECD Test Guideline 210, <strong>the</strong> Fish Life<br />
Cycle Test, or corresponding test methods is clearly noted.<br />
Endpoints are based on hatching success rate, growth (change in length and weight),<br />
spawning success rate, and survival rate.<br />
■ Crustacea:<br />
Chronic toxicity tests using crustacea shall be conducted in accordance with OECD Test<br />
Guideline 211 (Daphnia reproduction), US EPA OPPTS 850.1035 (Mysidacea chronic<br />
toxicity), or corresponding test methods (NOECs of 21 days <strong>for</strong> Daphnia, NOECs of 7<br />
days or more <strong>for</strong> Ceriodaphnia).<br />
Endpoints are based on <strong>the</strong> period up to <strong>the</strong> first spawning, number of eggs per female,<br />
growth, and survival rate.<br />
■ Algae (or o<strong>the</strong>r aquatic plants):<br />
・Algae: Since OECD Test Guideline 201 (Algae growth inhibition test, 72 or 96<br />
hours) is not a long-term test, its NOECs are not generally used as evidence <strong>for</strong><br />
exclusion from chronic aquatic toxicity. Yet, when <strong>the</strong> classification as acute aquatic<br />
toxicity is based on test result on a single species of algae or ano<strong>the</strong>r aquatic plant, and<br />
when NOECs exceed 1 mg/L <strong>for</strong> o<strong>the</strong>r species of algae, NOECs may be used as<br />
evidence <strong>for</strong> exclusion.<br />
In principle, growth inhibition (NOEC) by growth rate method is used <strong>for</strong> an<br />
209