F2024C00396 Rework skin irritation to restrict the in vitro study results to exposure bands 3 or 4

[Mike Dewhirst]

The changes here are represented by notes 20 and 21 below plus the addition of "(category 2)" in the third dot point.

Guidance 6.20.2 Section 30 of the IC General Rules - Information required to demonstrate the absence of hazard characteristics
For the purposes of subparagraph 30(2)(c)(iv) of the IC General Rules, the information required to demonstrate that a chemical does not have the hazard characteristic, skin irritation, is at least one of the following:

• if the human health exposure band for the introduction is 3²⁰ - a suitable in silico prediction indicating that the chemical is not irritating to the skin, or
• test results²¹ from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for skin irritation, with a non-irritant prediction, or
• test results²¹ from an in vivo study on the chemical or from suitable read across information, conducted following an acceptable test guideline for skin irritation, which does not result in skin reactions, as described for skin irritation (category 2) in chapter 3.2 of the GHS, or
• test results²¹ from an in vivo study on the chemical or from suitable read across information conducted following an acceptable test guideline for acute dermal toxicity, that when tested at 2,000 mg/kg bw/day is not irritating to the skin.

²⁰ This option is only available for introductions in human health exposure band 3
²¹ This option is available for introductions in human health exposure bands 3 or 4

[Mike Dewhirst]

The only change was to the wording of the Guidance regarding the definition of Category 2 Skin Irritation.