Project Description

OECD 439: In Vitro Skin Irritation using Reconstructed Human Epidermis (RhE)

irritation

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 guidelineOECD 439
What is being assessedTest substance induced irritation to skin
Why is this importantIdentification 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 SystemMatTek EpiDerm™ reconstituted human epidermis
Cytotoxicity measured using MTT
Test Item Requirements5 g / 5 ml
Preliminary TestingAssessment for MTT reducers; Test Chemical Interference; Mesh Reactivity

Skin Irritation OECD 439 Proficiency Summary

Test ChemicalUN GHS CategoryIn Vivo Dermal Irritation Score (OECD 404)*Physical StateExpected Skin Irritation Result*Gentronix Classification Correct?
Naphthalene acetic acidNo Classification, Non-Irritant0SolidNo Classification
IsopropanolNo Classification, Non-Irritant0.3LiquidNo Classification
Methyl stearateNo Classification, Non-Irritant1SolidNo Classification
Heptyl butyrateOptional Category 3, Mild Irritant1.7LiquidNo Classification**
Hexyl salicylateOptional Category 3, Mild Irritant2LiquidNo Classification**
Cyclamen aldehydeCategory 2, Irritant2.3LiquidRequires Classification
1-bromohexaneCategory 2, Irritant2.7LiquidRequires Classification
potassium hydroxide (5% aq.)Category 2, Irritant3LiquidRequires Classification
1-methyl-3-phenyl-1-piperazineCategory 2, Irritant3.3SolidRequires Classification
HeptanalCategory 2, Irritant3.4LiquidRequires Classification
*reported from OECD guideline 439
**UN GHS optional Category 3 considered as No Catergory in OECD 439
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