Registration Dossier
Registration Dossier
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EC number: 941-221-0 | CAS number: 203929-12-8
Endpoint summary
Administrative data
Description of key information
Skin and eye irritation studies were conducted on IOFH. The results of the studies were:
Skin irritation: Possible skin irritant, not corrosive to skin (Mildly irritating to skin (GHS Category 2)) in a study performed according to OECD 431.
Eye irritation: Not irritating in a study performed according to OECD 437.
Key value for chemical safety assessment
Additional information
The skin corrosion potential of the test article (clear colorless liquid, Batch: 41260127919j/Lot 2) was evaluated in an in vitro human skin model test. METHODS: This study was performed in compliance with OECD GLP (1997). The study design was based on OECD Guideline No. 431 (2013) and EC 440/2008 (2008). Human-derived keratinocytes were cultured to form a multilayered, highly differentiated model of the human epidermis. The tissues were kept refrigerated until the day of use, transferred to 6 well plates containing 0.9 mL DMEM medium, and then incubated for 2.5 hours at 37 C in 5% CO2. The test article (50 uL) was applied to 2 tissues for a 3 minute exposure and to 2 tissues for 1 hour exposure. The negative control (Milli-Q water) and the positive control (Potassium hydroxide- 8.0 normal solution) were applied (50 uL of each) in the same manner. Following the exposure periods, the tissues were washed with phosphate buffered saline (PBS). The DMEM medium was replaced with 300 uL MTT medium and then all tissues were again incubated for 3 hours at 37 C in 5% CO2. The tissues were then washed with PBS and formazan was extracted with 2 mL isopropanol. The amount of extracted formazan was determined spectrophotometrically at 540 nm in triplicate. Cell viability was then calculated as a percentage of the mean of the control tissues, and skin corrosion potential calculated from the optical density at 540 nm (OD540) measurements. The mean tissue viability of test article treated cells was 88% of the negative control after a 3 minute exposure and 95% after 1 hour exposure. The controls performed as expected indicating that the test was valid. Based on the results of the study, the test article is not corrosive in the in vitro skin corrosion test model and met the requirements of the test. As the study was performed according to OECD 431, a classification of Category 2 irritant was assigned.
The corneal irritation and damage potential of the test article (Clear colorless liquid, Batch: 41260127919/Lot 2) was tested in the Bovine Corneal Opacity and Permeability test (BCOP test). The study was performed in compliance with OECD GLP (98) 17 (1997). The test method was based on OECD no. 437 (2009), EC No. 440/2008 B. 47 (2010), OTWG- ICCVAM-NICEATM (2006), INVITTOX 127 (2006), and Gautheron, P. et al. 18: 442-449 (1992). Corneas were prepared in cell culture medium and incubated at 32 C for at least 1 hour prior to exposure. Corneas (3/group) were treated with 0.75 mL of undiluted MTDID 30531 test material and incubated in a horizontal position for 10 minutes at 32 C. A positive control (10% w/v Benzalkonium Chloride) and a negative control (physiological saline) were tested in parallel with the test material. At the end of the exposure period, the corneas were rinsed and incubated in fresh cell culture medium for 120 +/- 10 minutes at 32 C. Opacity was evaluated using an opacitometer after the 2 hour post-exposure incubation. Following opacity readings, the cell culture medium was replaced with Na-fluorescein medium and incubated for approximately 90 minutes at 32 C. Following the 90 minute Na-fluorescein exposure, permeability was measured. The mean in vitro irritation score (IVIS) was calculated and the scores were classified according to protocol defined categories. For the test article, the mean IVIS = -1.0 after 10 minutes. The mean opacity score was -1 and the mean permeability score was -0.001 (range -0.007 to 0.007). Controls performed as expected. No pH effect of the test substance was observed on the rinsing medium. Based on the results of the study, the test article is not an irritant to the cornea (IVIS = -1.0).
Justification for classification or non-classification
The test article is classified as irritating to the skin (Skin Irrit. 2) according to CLP criteria.
The test article does not meet the CLP classification criteria for eye irritation.
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