# 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 3.2.2.1.2.4: Animal irritant responses within a test can be variable, as they are with corrosion. A separate irritant criterion accommodates cases where there is a significant irritant response but less than the mean score criterion for a positive test. For example, a test material might be designated as an irritant if at least 1 of 3 tested animals shows a very elevated mean score throughout the study, including lesions persisting at the end of an observation period of normally 14 days. Other responses could also fulfil this criterion. However, it should be ascertained that the responses are the result of chemical exposure.

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

Table 3.2.2
Skin irritation category
Grading criteria are understood as described in Regulation (EC) No 440/2008.
Category
Criteria
Irritation (Category 2)
(1) Mean score of ≥ 2,3 and ≤ 4,0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
(2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling reactions; or
(3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above .

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Source: https://www.legislation.gov.uk/eur/2008/1272/annex/I/division/3/division/3.2/division/3.2.2/division/3.2.2.1/division/3.2.2.1.2/division/3.2.2.1.2.4 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-1272/annex-I/division-3/division-3.2/division-3.2.2/division-3.2.2.1/division-3.2.2.1.2/division-3.2.2.1.2.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.