GHS Classification Guidance for the Japanese Government

More documents

Recommendations

Info

done in parallel. This stage should be completed using validated and accepted SAR/SPR approaches. The SAR/SPR analysis may identify serious eye damage, corrosion and irritation potential for both skin and eye effects: (i) Step 2a - reliable determination of eye irritancy only by theoretical evaluations – in most cases it will only be appropriate for substances that are homologous to agents with very well known properties; (ii) Step 2c - theoretical evaluation of skin corrosivity - skin corrosive substances should not be instilled into the eyes of animals; such substances should be considered as leading to serious damage to the eyes as well (Category 1). Step 3: pH extremes like≤2 and ≥11.5 may indicate strong local effects, especially in combination with assessment of acid or alkaline reserve, substances exhibiting such physico-chemical properties should be considered as leading to serious damage to eyes (Category 1). Step 4: All attainable information should be used, including human experience. But this information should be restricted to that which pre-exists (e.g. the results of a skin LD50 test or historical information on skin corrosion). Step 5: These must be alternative methods for the assessment of eye irritation/ or serious damage to eyes (e.g. irreversible corneal opacity) which have been validated in accordance with internationally agreed principles and criteria (see section 1.3.2 in Chapter 1.3). Step 6: At present this step seems not to be achievable in the near future. Validated alternative methods for the reliable assessment of (reversible) eye irritation need to be developed. Step 7: In the absence of any other relevant information, it is essential to obtain this via an internationally recognized corrosion/irritation test before proceeding to a rabbit eye irritation test. This must be conducted in a staged manner. If possible, this should be achieved using a validated, accepted in vitro skin corrosivity assay. If this is not available, then the assessment should be completed using animal tests (see the skin irritation/ corrosion strategy, section 3.2.2). Step 8: Staged assessment of eye irritation in vivo. If in a limit test with one rabbit serious damage to eyes is detected no further testing is needed. Step 9: Only two animals may be employed for irritation testing (including the one used for evaluation of possible serious effects) if these two animals give concordant clearly irritant or clearly non-irritant responses. In the case of different or borderline responses a third animal is needed. Depending on the result of this three-animal test, classification may be required or not. 134
3-2-4 Respiratory or Skin Sensitization (1)Definitions Definitions of Respiratory or Skin Sensitization in UN GHS are as follows, and they are adopted in this guidance. 【GHS 2 nd revised edition】(3.4.1) 3.4.1.1 A respiratory sensitizer is a substance that will lead to hypersensitivity of the airways following inhalation of the substance 1 . contact 1 . A skin sensitizer is a substance that will lead to an allergic response following skin 3.4.1.2 For the purpose of this chapter, sensitization includes two phases: the first phase is induction of specialized immunological memory in an individual by exposure to an allergen. The second phase is elicitation, i.e. production of a cell-mediated or antibody-mediated allergic response by exposure of a sensitized individual to an allergen. 3.4.1.3 For respiratory sensitization, the pattern of induction followed by elicitation phases is shared in common with skin sensitization. For skin sensitization, an induction phase is required in which the immune system learns to react; clinical symptoms can then arise when subsequent exposure is sufficient to elicit a visible skin reaction (elicitation phase). A s a consequence, predictive tests usually follow this pattern in which there is an induction phase, the response to which is measured by a standardized elicitation phase, typically involving a patch test. The local lymph node assay is the exception, directly measuring the induction response. Evidence of skin sensitization in humans normally is assessed by a diagnostic patch test. 3.4.1.4 Usually, for both skin and respiratory sensitization, lower levels are necessary for elicitation than are required for induction. Provisions for alerting sensitized individuals to the presence of a particular sensitizer in a mixture can be found at section 3.4.4. (2)Classification criteria A) Classification criteria based on JIS Classification In JIS Classification, “Substances shall be classified as respiratory sensitizers Category 1 in accordance with the criteria given below:” a) If there is evidence in humans that the substance can lead to specfic respiratory hypersensitivity and/or b) If there are positive results from an appropriate animal test. Also, “Substances shall be classified as skin sensitizers Category 1 in accordance with the 135
Page 1:
GHS Classification Guidance for the
Page 4 and 5:
2-3-12 Substances and mixtures whic
Page 6 and 7:
Japanese judgments and consideratio
Page 8 and 9:
(2) Points to remember when describ
Page 10 and 11:
① ② Information Gathering Class
Page 13 and 14:
Part2. Physical Hazards Guidance 2-
Page 15 and 16:
described in the next section is of
Page 17 and 18:
Information in the book can be sear
Page 19 and 20:
(8) International Chemical Safety C
Page 21 and 22:
guidelines can be compared with GHS
Page 23 and 24:
“Liquids” are defined as substa
Page 25 and 26:
When a substance does not contain c
Page 27 and 28:
Table 2-2 Filled examples of "Not a
Page 29 and 30:
oxygen balance = -1600 [2x +(y/2) -
Page 31 and 32:
GHS classification 8)Self-reactive
Page 33 and 34:
The “Dangerous Goods Regulations,
Page 35 and 36:
4.2 4.3 5.1(I) 5.1(II) 5.1(III) 6.1
Page 37 and 38:
Table 2-5 Filled examples of “Cla
Page 39 and 40:
explosion hazard: (i) combustion of
Page 41 and 42:
water, by mass (n)GUANYLNITROSAMINO
Page 43 and 44:
substance 0224 BARIUM AZIDE, dry or
Page 45 and 46:
1337 NITROSTARCH, WETTED with not l
Page 47 and 48:
(4) Data availability Physical prop
Page 49 and 50:
flame distance (ignition distance)
Page 51 and 52:
Nitrogen trifluoride C і = 1.6 Nit
Page 53 and 54:
2-3-5 Gases Under Pressure (1)Defin
Page 55 and 56:
2-3-6 Flammable Liquids (1)Definiti
Page 57 and 58:
Category 3 =UNRTDG3 III Category 4
Page 59 and 60:
Table 2.7.1: Criteria for flammable
Page 61 and 62:
2-3-8 Self-reactive Substances and
Page 63 and 64:
2.8.2.3 Criteria for temperature co
Page 65 and 66:
3225 There is no article with a spe
Page 67 and 68:
classified according to it. If not,
Page 69 and 70:
classified”. Reference: UN GHS se
Page 71 and 72:
Table 2.11.1: Criteria for self-hea
Page 73 and 74:
than 30% water of crystallization 1
Page 75 and 76:
transport, the same chemical is to
Page 77 and 78:
138: Water-reactive substances - em
Page 79 and 80:
orohydrides, alkyl compounds, etc.)
Page 81 and 82:
2-3-13 Oxidizing Liquids (1)Definit
Page 83 and 84:
2-1-14 Oxidizing Solids (1)Definiti
Page 85 and 86:
(Example of category 3)2067 AMMONIU
Page 87 and 88: this class, according to the follow
Page 89 and 90: The flow chart of 2.15.2.2 is exact
Page 91 and 92: 2-3-16 Corrosive to Metals (1)Defin
Page 93: Note: In GHS, it is defined that if
Page 96 and 97: 1-1) Organization National Institut
Page 98 and 99: URL http://www.ecetoc.org/publicati
Page 100 and 101: List 2: Useful information sources
Page 102 and 103: http://www.cdc.gov/niosh/npg/npgdrt
Page 104 and 105: 3-1-3 Management of information in
Page 106 and 107: Relation between concentration(ppm)
Page 108 and 109: follows: Category 1 (100 ppmV), Cat
Page 110 and 111: (ii) the appropriate conversion val
Page 112 and 113: UNRTDG Class 6.1 is not sub-categor
Page 114 and 115: possible” unless the obvious conc
Page 116 and 117: whereas the reference value is set
Page 118 and 119: 3-2-2 Skin Corrosion/Irritation (1)
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 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 170 and 171: e considered to be sufficient. (Sub
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
Page 220 and 221:
R39 Danger of very serious irrevers
Page 222:
R52 Harmful to aquatic organisms. R
show all

GHS Classification Guidance for the Japanese Government

Create successful ePaper yourself

Delete template?

Save as template?