Reaction product of 2-hydroxybenzoic acid, styrene and oxozinc

Endpoint summary

Description of key information

Reaction product of 2-hydroxybenzoic acid, styrene and oxozinc was tested for in vitro skin and eye corrosion properties according to OECD guideline 431 (2004) and 437 (2009), respectively. The test substance did not show any skin or eye irritation properties.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation

Two tissues of the human skin model EpiDermTM were treated with Reaction product of 2-hydroxybenzoic acid, styrene and oxozinc for three minutes and one hour, respectively. In average, 25.1 mg of the solid test item were applied to each tissue and spread to match the tissue size.

Deionised water was used as negative control, 8 m KOH was used as positive control. After treatment with the negative control the absorbance values were well above the required acceptability criterion of mean OD > 0.8 for both treatment intervals thus showing the quality of the tissues. The positive control showed clear corrosive effects for both treatment intervals. After three minutes treatment with the test item, the relative absorbance values were increased to 102.5 %. This value is well above the threshold for corrosion potential (50%). After one hour treatment, relative absorbance values were increased to 112.5 %. This value, too, is well below the threshold for corrosion potential (15%). Therefore, Reaction product of 2-hydroxybenzoic acid, styrene and oxozinc is considered not corrosive in the Human Skin Model Test.

Eye Irritation

This in vitro study was performed to assess the corneal irritation and damage potential of Reaction product of 2-hydroxybenzoic acid, styrene and oxozinc by quantitative measurements of changes in opacity and permeability in a bovine cornea. The test item Reaction product of 2-hydroxybenzoic acid, styrene and oxozinc was brought onto the cornea of a bovine eye which previously had been incubated with cMEM without Phenol red at 32±1°C for one hour and whose opacity had been determined. The test item was incubated on the cornea for 4 hours at 32±1°C. After removal of the test item, opacity and permeability values were measured. Physiological sodium chloride solution was used as negative control, imidazole (20% solution in 0.9% sodium chloride solution) was used as positive control. The positive control induced a very severe irritation on the cornea, mean IVIS was 94.6580. The negative control showed no irritation, mean IVIS was 0.6500. The test item was tested pure. A mean IVIS of 0.5950 was calculated, corresponding to a classification as not eye irritant. The applied amount of test item did not show any correlation to the calculated IVIS. No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.

Justification for classification or non-classification

Based on data available on irritation/corrosion properties, Reaction product of 2-hydroxybenzoic acid, styrene and oxozinc was not classified and labelled according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).