OECD 439: In Vitro Skin Irritation using Reconstructed Human Epidermis (RhE)
SERVICE INFORMATION
Skin irritation may be avoided by proper hazard identification prior to chemical use. Performed in reconstructed human epidermis, the in vitro OECD 439 skin irritation test can be used to determine whether non-corrosive substances may cause skin irritation without having to resort to in vivo testing. This can be part of a top-down or bottom-up approach in conjunction with skin corrosion and sensitisation test strategies.
Skin irritation testing has been validated, and laboratory proficiency under OECD 439 established at Gentronix, with services available in both GLP and non-GLP formats.
| OECD guideline | OECD 439 |
| What is being assessed | Test substance induced irritation to skin |
| Why is this important | Identification of substances with skin irritation potential is an important aspect of chemical risk assessment and hazard classification. Skin irritants can also induce inflammation, which may be a precursor for skin sensitisation. |
| Test System | MatTek EpiDerm™ reconstituted human epidermis Cytotoxicity measured using MTT |
| Test Item Requirements | 5 g / 5 ml |
| Preliminary Testing | Assessment for MTT reducers; Test Chemical Interference; Mesh Reactivity |
Skin Irritation OECD 439 Proficiency Summary
| Test Chemical | UN GHS Category | In Vivo Dermal Irritation Score (OECD 404)* | Physical State | Expected Skin Irritation Result* | Gentronix Classification Correct? |
|---|---|---|---|---|---|
| Naphthalene acetic acid | No Classification, Non-Irritant | 0 | Solid | No Classification | |
| Isopropanol | No Classification, Non-Irritant | 0.3 | Liquid | No Classification | |
| Methyl stearate | No Classification, Non-Irritant | 1 | Solid | No Classification | |
| Heptyl butyrate | Optional Category 3, Mild Irritant | 1.7 | Liquid | No Classification** | |
| Hexyl salicylate | Optional Category 3, Mild Irritant | 2 | Liquid | No Classification** | |
| Cyclamen aldehyde | Category 2, Irritant | 2.3 | Liquid | Requires Classification | |
| 1-bromohexane | Category 2, Irritant | 2.7 | Liquid | Requires Classification | |
| potassium hydroxide (5% aq.) | Category 2, Irritant | 3 | Liquid | Requires Classification | |
| 1-methyl-3-phenyl-1-piperazine | Category 2, Irritant | 3.3 | Solid | Requires Classification | |
| Heptanal | Category 2, Irritant | 3.4 | Liquid | Requires Classification | |
| *reported from OECD guideline 439 **UN GHS optional Category 3 considered as No Catergory in OECD 439 |
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