1. Toksisitas akut
Definisi toksisitas akut adalah efek negatif yang terjadi ketika sesuatu masuk kedalam tubuh melalui cara tertelan atau terserap melalui kulit dalam waktu 24 jam maupun terhirup lebih dari 4 jam
Perkiraan Nilai Kategori Toksisitas Akut
Exposure route |
1
|
2
|
3
|
4
|
5
|
Oral (mg/kg bodyweight) See notes (a) and (b) |
5
|
50
|
300
|
2000
| 5000 See detailed criteria in Note (g) |
Dermal (mg/kg bodyweight) See notes (a) and (b) |
50
|
200
|
1000
|
2000
| |
Gases (ppmV) See notes (a), (b) and © |
100
|
500
|
2500
|
20000
| |
Vapours (mg/1) See notes (a), (b), (c), (d) and (e) |
0.5
|
2
|
10
|
20
| See detailed criteria in Note (g) |
Dusts and Mists (mg/1) See notes (a), (b), (c) and (1) |
0.05
|
0.5
|
1
|
5
|
Notes to Table:
(a). The acute toxicity estimate (ATE) for the classification of a substance is derived using the LD50/LC50 where available;
(b). The acute toxicity estimate (ATE) for a substance in a mixture is derived using:
(i). the LD50/L C50 where available; otherwise,
(ii). the appropriate conversion value from Table 3.1.2 that relates to the results of a range test; or
(iii). The appropriate conversion value from Table 3.1.2 that relates to a classification category;
(c). Inhalation cut-off values in the table are based on 4 hour testing exposures. Conversion of existing inhalation toxicity data which has been generated according to 1 hour exposures should be by dividing by a factor of 2 for gases and vapours and 4 for dusts and mists;
(d). It is recognized that saturated vapour concentration may be used as an additional element by some regulatory systems to provide for specific health and safety protection. (e.g. UN Recommendations for the Transport of Dangerous Goods);
(e). For some substances the test atmosphere will not just be a vapour but will consist of a mixture of liquid and vapour phases. For other substances the test atmosphere may consist of a vapour which is near the gaseous phase. In these latter cases, classification should be based on ppmV as follows: Category 1 (100 ppm9, Category 2 (500 ppm9, Category 3 (2500 ppm9, Category 4 (20000 ppm9.
The terms “dust”, “mist” and “vapour” are defined as follows:
(i). Dust: solid particles of a substance or mixture suspended in a gas (usually air);
(ii). Mist: liquid droplets of a substance or mixture suspended in a gas (usually air);
(iii). Vapour: the gaseous form of a substance or mixture released from its liquid or solid state.
Dust is generally formed by mechanical processes. Mist is generally formed by condensation of supersatured vapours or by physical shearing of liquids. Dusts and mists generally have sizes ranging from less than 1 to about 100 pm;
The values for dusts and mists should be reviewed to adapt to any future changes to OECD Test Guidelines with respect to technical limitation in generating, maintaining and measuring dust and mist concentrations in respirable form;
(g). Criteria for Category 5 are intended to enable the identification of substances which are of relatively low acute toxicity hazard but which under certain circumstances may present a danger to vulnerable populations. These substances are anticipated to have an oral or dermal LD50 in the range of 2000-5000 mg/kg bodyweight and equivalent doses for inhalation. The specific criteria for Category 5 are:
(i). The substance is classified in this Category if reliable evidence is already available that indicates the LD50 (or LC50) to be in the range of Category 5 values or other animal studies or toxic effects in humans indicate a concern for human health of an acute nature.
(ii). The substance is classified in this Category, through extrapolation, estimation or measurement of data, if assignment to a more hazardous category is not warranted, and:
- reliable information is available indicating significant toxic effects in humans; or
- any mortality is observed when tested up to Category 4 values by the oral, inhalation, or dermal routes; or
- where expert judgement confirms significant clinical signs of toxicity, when tested up to Category 4 values, except for diarrhoea, piloerection or an ungroomed appearance; or
- where expert judgement confirms reliable information indicating the potential for significant acute effects from other animal studies.
Recognizing the need to protect animal welfare, testing in animals in Category 5 ranges is discouraged and should only be considered when there is a strong likelihood that results of such a test would have a direct relevance for protecting human health.
Unsur-Unsur Label Pada Kategori Toksisitas Akut
Kategori
|
1
|
2
|
3
|
4
|
5
|
Kata Sinyal | Bahaya | Bahaya | Bahaya | Awas | Awas |
Pernyataan Bahaya: Oral | Fatal jika tertelan | Fatal jika tertelan | Toksik jika tertelan | Berbahaya jika tertelan | Dapat berbahaya jika tertelan |
Pernyataan Bahaya: Kulit | Fatal jika terkena kulit | Fatal jika terkena kulit | Toksik jika terkena kulit | Berbahaya jika terkena kulit | Dapat berbahaya jika terkena kulit |
Pernyataan Bahaya: Terhirup | Fatal jika terhirup | Fatal jika terhirup | Toksik jika terhirup | Berbahaya jika terhirup | Dapat berbahaya jika terhirup |
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