GHS Classification Guidance for the Japanese Government
GHS Classification Guidance for the Japanese Government GHS Classification Guidance for the Japanese Government
e considered to be sufficient. (Substance not classified in Category 1A) * * This includes a case where it is described in the materials in List 2 that reproductive toxicity is recognized with humans. Not classified : Substance which is clearly determined to have no human reproductive/developmental toxicity (Decision criteria) When it is clear from appropriate reproductive toxicity test results that a substance has no reproductive toxicity, the substance is determined to be placed in “Not classified”. In addition, when a substance falls under any of the following conditions, it is classified in “Not classified”. a) Substances are placed in “Not classified” for which adverse effects on reproductive function, fertility, or development are reported that are considered to be induced as non-specific secondary effects of other toxicity effects. b) Substances are placed in "Not classified" with which the manifestation of reproductive toxicity in animals is proved to be caused by a mechanism inherent to the animal species or for which reproductive toxicity is not manifested in humans due to significant differences in toxicokinetics. c) Substances with low toxicological importance or induce only minimum effects (small changes in sperm measurement items, incidence of spontaneous defects in fetus, variant/ossoification retardation, fetal/pup body weight, and postnatal development indexes) are also determined as “Not classified”. 3) Points to be noted in classification a) When exposure of reproductive organs to test material is at a unrealistically high level in a test using administration routes such as intravenous injection or intra-abdominal injection, or when local damage is caused to reproductive organs by irritation or other factors, the result of such a test is not used as the basis of classification. Adverse effects on reproduction recognized only at an extremely high dose (for example, a dose that induces prostration, severe inappetence, and high mortality) in an animal test are not used as the basis of classification, unless information is available of, for example, toxicokinetics indicating that humans are more susceptible than animals, supporting the appropriateness of the classification. b) A substance for which available information regarding reproductive toxicity is determined as insufficient to make a final decision is to be placed in “Classification not possible” because sufficient information is not available for GHS classification. An expert's judgment shall be sought for when necessary. 166
c) Effects on or via lactation When a description regarding effects on or via lactation is found, an expert's judgment shall be sought for. The expert judges whether the substance has "effects on or via lactation" from his/her expertise based on GHS. d) Substances requiring cautions in classification Reference 1 cited at the end of this item lists the following substances as human teratogens. Since substances subsumed under these can be classified in “Category 1A”, information about them should be collected with special care in accordance with this guidance. Alcohol Anticancer agents (Aminopterin, Busulfan, Chlorambucil, Methotrexate, Cytarabine, Cyclophosphamide, Mechlorethamine) Androgenic hormones Antityroid drugs, Aminoglycoside antibiotics Coumarine anticoagulants Diethylstilbestrol Methyl mercury PCBs Thalidomide Anticonvulsants (Hydantoin, Primidone, Carbamazepine, Diones, Valproic acid) Penicillamine Lithium Cocaine Retinoic acids ACE inhibitors Toluene, Tetracyclines (Schardein, 2000、Table 1-18) Item 1 also contains the list of substances considered to cause male-mediated developmental toxicity (Schardein, 2000,Table 1-9) and the list of example substances having toxicity to development by California Proposition 65 (Schardein, 2000, Table 1-16). The substances shown there should be examined with special care in accordanace with this guidance, and information sufficient for decision should be collected. e) Limit dose In the UN GHS second revised edition 3.7.2.5.9, it is described that 1000 mg/kg can be adopted as a limit dose. When a dose is more than 1000 mg/kg, do not apply the limit dose mechanically, but judgment by expert's regarding the adoption of the limit dose shall be sought for. OECD test guidelines defining a limit dose and the limit dose defined therein are shown below. 167
- Page 120 and 121: Table 3.2.2 Skin irritation categor
- Page 122 and 123: possible, and to classify the subst
- Page 124 and 125: and scaling persist to the end of 1
- Page 126 and 127: 【GHS 2 nd revised edition】 Figu
- Page 128 and 129: [Note for the above figure] (a) Cla
- Page 130 and 131: B) Classification criteria in GHS (
- Page 132 and 133: (4)Guidance for classification and
- Page 134 and 135: G) Strategy of testing and evaluati
- Page 136 and 137: 2c Structure activity Skin corrosiv
- Page 138 and 139: done in parallel. This stage should
- Page 140 and 141: criteria given below:” a) If ther
- Page 142 and 143: [Decision Criteria 1]: In the cases
- Page 144 and 145: substance shall be classified in Ca
- Page 146 and 147: The classification is based on any
- Page 148 and 149: 7) Data from various kinds of tests
- Page 150 and 151: Table 3-8 Test data as the basis of
- Page 152 and 153: Category 1B. Mutagens classified a
- Page 154 and 155: c)Exceptionally, strong positive re
- Page 156 and 157: 3-2-6 Carcinogenicity (1)Definition
- Page 158 and 159: The principles of GHS classificatio
- Page 160 and 161: B) Substance for which GHS classifi
- Page 162 and 163: metabolic system, a cautious invest
- Page 164 and 165: hazard warning for pregnant women a
- Page 166 and 167: OECD414 Prenatal development toxici
- Page 168 and 169: D) Decision logic and classificatio
- Page 172 and 173: No. Test guideline Limit dose 414 P
- Page 174 and 175: 3-2-8 Specific Target Organ Toxicit
- Page 176 and 177: specifically for these effects as d
- Page 178 and 179: existing MSDSs. A literature search
- Page 180 and 181: * Unless a description that definit
- Page 182 and 183: g) When the affected organ can be i
- Page 184 and 185: 3-2-9 Specific Target Organ Toxicit
- Page 186 and 187: Table 3-16: Guidance value ranges f
- Page 188 and 189: (c) Any consistent and significant
- Page 190 and 191: has received some degree of approva
- Page 192 and 193: As for the classification of specif
- Page 194 and 195: formed in the mouth, which then may
- Page 196 and 197: The classification criteria refer t
- Page 198 and 199: 194
- Page 200 and 201: (1)Sources for test data for Hazard
- Page 202 and 203: List 2: Useful information sources
- Page 204 and 205: 3-3)EU classification When classif
- Page 206 and 207: 4-2 Classification of Hazardous to
- Page 208 and 209: water solubility, and which are not
- Page 210 and 211: Tests shall be conducted by using f
- Page 212 and 213: e categorized based on chronic aqua
- Page 214 and 215: endpoint. When it is not clear whet
- Page 216 and 217: that the relevant information sourc
- Page 218 and 219: 214
c) Effects on or via lactation<br />
When a description regarding effects on or via lactation is found, an expert's<br />
judgment shall be sought <strong>for</strong>. The expert judges whe<strong>the</strong>r <strong>the</strong> substance has "effects on or<br />
via lactation" from his/her expertise based on <strong>GHS</strong>.<br />
d) Substances requiring cautions in classification<br />
Reference 1 cited at <strong>the</strong> end of this item lists <strong>the</strong> following substances as human<br />
teratogens. Since substances subsumed under <strong>the</strong>se can be classified in “Category 1A”,<br />
in<strong>for</strong>mation about <strong>the</strong>m should be collected with special care in accordance with this<br />
guidance.<br />
Alcohol<br />
Anticancer agents (Aminopterin, Busulfan, Chlorambucil, Methotrexate, Cytarabine,<br />
Cyclophosphamide, Mechlorethamine)<br />
Androgenic hormones<br />
Antityroid drugs, Aminoglycoside antibiotics<br />
Coumarine anticoagulants<br />
Diethylstilbestrol<br />
Methyl mercury<br />
PCBs<br />
Thalidomide<br />
Anticonvulsants (Hydantoin, Primidone, Carbamazepine, Diones, Valproic acid)<br />
Penicillamine<br />
Lithium<br />
Cocaine<br />
Retinoic acids<br />
ACE inhibitors<br />
Toluene, Tetracyclines (Schardein, 2000、Table 1-18)<br />
Item 1 also contains <strong>the</strong> list of substances considered to cause male-mediated<br />
developmental toxicity (Schardein, 2000,Table 1-9) and <strong>the</strong> list of example substances<br />
having toxicity to development by Cali<strong>for</strong>nia Proposition 65 (Schardein, 2000, Table<br />
1-16). The substances shown <strong>the</strong>re should be examined with special care in accordanace<br />
with this guidance, and in<strong>for</strong>mation sufficient <strong>for</strong> decision should be collected.<br />
e) Limit dose<br />
In <strong>the</strong> UN <strong>GHS</strong> second revised edition 3.7.2.5.9, it is described that 1000 mg/kg can<br />
be adopted as a limit dose. When a dose is more than 1000 mg/kg, do not apply <strong>the</strong> limit<br />
dose mechanically, but judgment by expert's regarding <strong>the</strong> adoption of <strong>the</strong> limit dose<br />
shall be sought <strong>for</strong>. OECD test guidelines defining a limit dose and <strong>the</strong> limit dose<br />
defined <strong>the</strong>rein are shown below.<br />
167
Change language