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

SERVICE INFORMATION

Skin irritation may be avoided by proper hazard identification prior to chemical use. Performed in the 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.

We provide an exceptional quality, responsive service with high capacity to address our clients needs.

FIND OUT MORE

For innovative solutions in both genetic toxicology and skin toxicology, contact us and see how we can help.

Or contact us on info@gentronix.co.uk or +44 (0) 1625 238700

MORE ABOUT OECD 439

For further details on how Gentronix can support the risk assessment of your materials, please take a look at our GLP Skin toxicology services.

ASSESSMENT INFORMATION

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

PROFICIENCY SUMMARY TABLE

Test Chemical	UN GHS Category	In Vivo Dermal Irritation Score (OECD 404)*	Physical State	Expected Skin Irritation Result*
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

Talk to a Toxicologist

info@gentronix.co.uk | +44 (0) 1625 238700

GET IN TOUCH

SKIN & OCULAR SAFETY SUPPORTING COSMETIC REGULATORY TESTING AS NON-ANIMAL ALTERNATIVES METHODS

Skin Toxicology
OECD 431 Skin Corrosion OECD 439 Skin Irritation

Ocular Toxicology
OECD 492 EpiOcular OECD 437 BCOP

Skin Sensitisation
OECD 442C DPRA OECD 442D KeratinoSensTM OECD 442E h-CLAT