Registration Dossier

Administrative data

Description of key information

2 in-vivo studies for skin irritation/corrosion and eye irritation from a secondary source were available.
Additionally for the evaluation of the skin corrosion/irritating properties of m-trifluoromethylphenylisocyanate (alpha,alpha,alpha-trifluoro-3-tolyl isocyanate) an artificial 3D-skin model test according to OECD TG 439 was used.
For assessing ocular irritation of compounds an in-vitro study using a human epithelial corneal cell model was conducted. The model used is standardized and commercially available (SkinEthic™ Human Corneal Epithelial Model (HCE); SkinEthic, France). Further m-trifluoromethylphenylisocyanate (alpha,alpha,alpha-trifluoro-3-tolyl isocyanate) was tested using the Hen's egg chorioallantoic membrane (HET-CAM) test according to the ICCVAM Test Method Evaluation Report: Appendix G: ICCVAM Recommended Protocol for Future Studies Using the Hen's Egg Test-Chorionallantoic Membrane (HET-CAM) Test method, November 2006.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

In an occlusive patch test with an exposure period of 24 hours and an eye irritation study according an unspecified FDA guideline alpha,alpha,alpha-trifluoro-3-tolyl isocyanate was irritatiant to the skin and eyes. From these studies no score values are availabe.

In the in-vitro 3D skin irritation test m-trifluoromethylphenylisocyanatewas irritating - but not corrosive.

In the reconstituted human ocular epithelia (SkinEthic™ Human Corneal Epithelial Model (HCE); SkinEthic, France) m-trifluoro-methylphenylisocyanate was irritant. Also in the HET-CAM test using the chorionallantoic membrane (HET-CAM, 8d incubation) of chicken eggs m-trifluoromethylphenylisocyanate was irritant.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Due to the results of the skin irritation studies R 38 (Skin Irrit. 2; H 315) is justified.

Due to the results of the eye irritation study R 41 (Eye Dam. 1; H318) is adequate.

In addition, respiration irritational effects were reported. Therefore R 37 is applicable