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Description of key information

Two in vitro study are available, one evaluating the skin corrosion potency (BASF SE, 2009; report No. 61H0646/082175) of the test substance conducted according to the OECD Guideline for Testing of Chemicals No. 431, April 13, 2004 (“In vitro Skin Corrosion: Human Skin Model Test”), and one evaluating if the test substance can cause serious damage to the eye (BASF SE, 2009; report No. 60H0646/082176; HET-CAM in vitro system), which follows the testing strategy for determination of eye irritation/corrosion as given the OECD guideline 405.
Based on the results of this study and applying the evaluation criteria, it is concluded, that Gelb LD 6259 does not show a corrosive potential and does not produce changes indicative for serious eye under the test conditions chosen. The test method does not yet allow for the evaluation of skin or eye irritation and the result does therefore not exclude an irritation potential of the test substance. For final assignment of a risk phrase at present, results from an in vivo study would be needed.

Key value for chemical safety assessment

Additional information

IN VITRO SKIN IRRITATION

In the OECD Guideline 431 study, 2 tissues (EpiDerm™ 200 kit) per exposure time (3 minutes at room temperature or 1 hour in the incubator, as a rule) and test group (test material, negative control and positive control; 12 tissues per test) were used. 25 μL highly deionized water was applied first. Thereafter, a bulk volume of 25 μL of the solid test material was applied with a sharp spoon and homogeneously distributed with the water. Control tissues were concurrently applied with 50 μL of highly deionized water (negative control, NC) or with 50 μL of potassium hydroxide (positive control, PC).

The tissues were washed with PBS to remove residual test material and kept in 24-well plates (holding plates) at room temperature on assay medium until all tissues per application time were dosed and rinsed. The assay medium was then replaced by MTT solution and tissues were incubated for 3 hours.

After incubation, tissues were washed with PBS and the formazan produced by the tissues was extracted with isopropanol over night at room temperature. The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically. Blank values were established of 3 microtiter wells filled with Isopropanol for each microtiter plate.

Then, the quantification of tissue viability is calculated as the quotient of the mean OD570 divided by the respective OD570 NC value in percent for each exposure time. The test substance was considered as "corrosive", if the mean relative tissue viability after 3 min treatment with a test material is decreased below 50%.

Based on the observed results and applying the evaluation criteria cited above it was concluded, that Gelb LD 6259 does not show a corrosive potential in the EpiDerm skin corrosivity test under the test conditions chosen.

 

IN VITRO EYE IRRITATION

In the HET-CAM Test: a bulk volume of 25 μL (about 15 mg; per egg of the ground solid test substance) was applied on approximately the half of the membrane area, starting from the center, after careful removal of the eggshell including the inner membrane directly onto the chorionallantoic membrane. The chorionallantoic membrane was then observed by means of a stereomicroscope until unambiguous irritation reactions were detected or up to a maximum time period of 50 seconds, respectively.

The time of appearance (in seconds after application) of intravascular resp. extravascular coagulation, and if applicable other reactions (haemorrhagia, vessel lysis), were determined. The following grading was used: 0 (No visible change); 1 (Slight reaction); 2 (Moderate reaction); and 3 (Severe reaction). Any further findings not covered by this scale were recorded.

The Gelb LD 6259 does not produce changes indicative for serious eye damage in the HET-CAM Test under the test conditions chosen.

Justification for classification or non-classification