GHS Classification Guidance for the Japanese Government
GHS Classification Guidance for the Japanese Government GHS Classification Guidance for the Japanese Government
D) Decision logic and classification of substances 1) Decision logic for substances Decision is performed according to the UN GHS second revised edition 3.7.5.1 Decision logic for reproductive toxicity. The possibility that the toxicity for dam animals may be secondary result should be examined sufficiently. (For example, see the UN GHS second revised edition 3.7.2.4) 2) Classification In principle, information shall be collected according to this guidance, and substances shall be classified in accordance with the collected data. [Substance to be determined as “Classification not possible”] A substance is determined to be placed in “Classification not possible” when no data on reproductive toxicity of the substance is available. [Substance to be classified as]: Category 1A: Substance known to have adverse effect on human sexual functions, fertility, or development of offspring (Decision criteria) A substance which is clearly described as recognized to have reproductive toxicity in humans in information of list 1. * When other substances are considered to fall under Category 1A, an expert's decision shall be sought for. * When a substance falls under “③ 4)Substance requiring caution on classification” given below and when information sufficiently proving that the substance falls under Category 1A is not obtained as a result of literature survey based on this classification guidance, an expert's decision shall be sought for. Category 1B: Substance presumed to have adverse effect on human sexual functions, fertility, or development of offspring (Decision criteria) Substances which meet the following conditions. Substances corresponding to “Not classified” are excluded, however. Substances for which it is described in the materials in List 1 that clear reproductive toxicity* (except for small changes in sperm measurement items, incidence of spontaneous defects in fetus, variant/ossoification retardation, fetal/pup body weight, and postnatal development indexes) is manifested in animal experiments at a dose at which general toxicity (which is not limited to maternal toxicity but defined as effects other than reproductive toxicity to female and male parental animals; the same shall 164
apply hereinafter) is not manifested in parental animals. * The reproductive toxicity here means reproductive toxicity defined in c), that is, effects on parental sexual function, fertility, and development. The same shall apply throughout this guidance. Category 2:Substance suspected to have toxicity for human reproduction/development (Decision criteria) Substances which meet any of the following conditions with information in List 1or List 2. Substances corresponding to “Category 1” and “Not classified” are excluded, however. a) Substances for which it is described that clear reproductive toxicity (except for small changes in sperm measurement items, incidence of spontaneous defects in fetus, variant/ossoification retardation, fetal/pup body weight, and postnatal development indexes) is manifested in animal experiments at a dose at which general toxicity in parental animals is manifested. It is to be noted, however, that cases are reported that indicate a relationship between serious effects on parental animals (death, significant inhibition of body weight increase, etc.) and effects on fetus (Khera KS 1984: Teratology 29, 411-416, Carny EW et. al. 2004: Toxicol. Sci. 82, 234-249, Fleeman TL et. al. 2005: Birth Defects Research (Part B) 74, 442-449). When there is a definite relationship between them, the substances are classified in “Not classified”. b) Substances for which no description on general toxicity for parental animals in animal experiments is available but which is described to result in clear manifestation of reproductive toxicity (except for small changes in sperm measurement items, incidence of spontaneous defects in fetus, variant/ossoification retardation, fetal/pup body weight, and postnatal development indexes). (In general, the dose at which general toxicity is manifested may not be clear in review documents. In such cases, it is preferable to review the original literature and to confirm the dosage.) (Special case) A substance for which it is described in the materials in List 2 that clear reproductive toxicity (except for small changes in sperm measurement items, incidence of spontaneous defects in fetus, variant/ossoification retardation, fetal/pup body weight, and postnatal development indexes) is manifested at a dosage at which general toxicity is not manifested is to be placed in Category 2 in this guidance since there is no sufficient proof (evidence) to classify it in Category 1B. c) Substance of which reports on human reproductive toxicity are available that can not 165
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D) Decision logic and classification of substances<br />
1) Decision logic <strong>for</strong> substances<br />
Decision is per<strong>for</strong>med according to <strong>the</strong> UN <strong>GHS</strong> second revised edition 3.7.5.1<br />
Decision logic <strong>for</strong> reproductive toxicity. The possibility that <strong>the</strong> toxicity <strong>for</strong> dam animals<br />
may be secondary result should be examined sufficiently. (For example, see <strong>the</strong> UN <strong>GHS</strong><br />
second revised edition 3.7.2.4)<br />
2) <strong>Classification</strong><br />
In principle, in<strong>for</strong>mation shall be collected according to this guidance, and substances<br />
shall be classified in accordance with <strong>the</strong> collected data.<br />
[Substance to be determined as “<strong>Classification</strong> not possible”]<br />
A substance is determined to be placed in “<strong>Classification</strong> not possible” when no data on<br />
reproductive toxicity of <strong>the</strong> substance is available.<br />
[Substance to be classified as]:<br />
Category 1A: Substance known to have adverse effect on human sexual functions,<br />
fertility, or development of offspring<br />
(Decision criteria)<br />
A substance which is clearly described as recognized to have reproductive toxicity in<br />
humans in in<strong>for</strong>mation of list 1.<br />
* When o<strong>the</strong>r substances are considered to fall under Category 1A, an expert's decision<br />
shall be sought <strong>for</strong>.<br />
* When a substance falls under “③ 4)Substance requiring caution on classification”<br />
given below and when in<strong>for</strong>mation sufficiently proving that <strong>the</strong> substance falls<br />
under Category 1A is not obtained as a result of literature survey based on this<br />
classification guidance, an expert's decision shall be sought <strong>for</strong>.<br />
Category 1B: Substance presumed to have adverse effect on human sexual functions,<br />
fertility, or development of offspring<br />
(Decision criteria)<br />
Substances which meet <strong>the</strong> following conditions. Substances corresponding to “Not<br />
classified” are excluded, however.<br />
Substances <strong>for</strong> which it is described in <strong>the</strong> materials in List 1 that clear reproductive<br />
toxicity* (except <strong>for</strong> small changes in sperm measurement items, incidence of<br />
spontaneous defects in fetus, variant/ossoification retardation, fetal/pup body weight,<br />
and postnatal development indexes) is manifested in animal experiments at a dose at<br />
which general toxicity (which is not limited to maternal toxicity but defined as effects<br />
o<strong>the</strong>r than reproductive toxicity to female and male parental animals; <strong>the</strong> same shall<br />
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