# Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance), Division 3.1.2.1: Substances can be allocated to one of four hazard categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric cut-off criteria as shown in the table below. Acute toxicity values are expressed as (approximate) LD 50 (oral, dermal) or LC 50 (inhalation) values or as acute toxicity estimates (ATE). While some in vivo methods determine LD 50 /LC 50 values directly, other newer in vivo methods (e.g. using fewer animals) consider other indicators of acute toxicity, such as significant clinical signs of toxicity, which are used as a reference to assign the hazard category. Explanatory notes are shown following Table 3.1.1.

Extent: E+W+S+N.I.

Table 3.1.1
Acute toxicity estimate (ATE) values and criteria for acute toxicity hazard categories.
Gas concentrations are expressed in parts per million per volume (ppmV).
Exposure route
Category 1
Category 2
Category 3
Category 4
Oral (mg/kg bodyweight)
ATE ≤ 5
5 < ATE ≤ 50
50 < ATE ≤ 300
300 < ATE ≤ 2 000
See:
Note (a)
Note (b)
Dermal (mg/kg bodyweight)
ATE ≤ 50
50 < ATE ≤ 200
200 < ATE ≤ 1 000
1 000 < ATE ≤ 2 000
See:
Note (a)
Note (b)
Gases (ppmV )
ATE ≤ 100
100 < ATE ≤ 500
500 < ATE ≤ 2 500
2 500 < ATE ≤ 20 000
see:
Note (a)
Note (b)
Note (c)
Vapours (mg/l)
ATE ≤ 0,5
0,5 < ATE ≤ 2,0
2,0 < ATE ≤ 10,0
10,0 < ATE ≤ 20,0
see:
Note (a)
Note (b)
Note (c)
Note (d)
Dusts and mists (mg/l)
ATE ≤ 0,05
0,05 < ATE ≤ 0,5
0,5 < ATE ≤ 1,0
1,0 < ATE ≤ 5,0
see:
Note (a)
Note (b)
Note (c)

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Source: https://www.legislation.gov.uk/eur/2008/1272/annex/I/division/3/division/3.1/division/3.1.2/division/3.1.2.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-1272/annex-I/division-3/division-3.1/division-3.1.2/division-3.1.2.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.