Reaction mass of 1,2-Benzenedicarboxylic acid, 4-sulfo-, trisodium salt, 1,2-Benzenedicarboxylic acid, 3-sulfo-, sodium salt (1:3), Sodium sulphate

Endpoint summary

Description of key information

Skin irritation (OECD 431/439): not irritating (BASF SE, 2012)
Eye irritation/corrosion (OECD405): not irritating (Bioassay, 2012)

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

In a GLP compliant in vitro EpiDerm™ test (BASF SE, 2012) according to OECD guidelines 431 and 439, the potential of Produkt SPS to cause dermal corrosion/irritation was assessed by a single topical application of 25 μL bulk volume (about 14 mg) of the test substance to a reconstructed three dimensional human epidermis model. For the corrosion test two EpiDerm™ tissue samples were incubated with the test substance for 3 minutes and 1 hour, respectively. The irritation test was performed with three EpiDerm™ tissue samples, which were incubated with the test substance for 1 hour followed by a 42-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.

The test substance is not able to reduce MTT directly. In the corrosion test, the mean viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 104%, and it was 77% after an exposure period of 1 hour. In the irritation test, the mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 115%. Based on the observed results and applying the evaluation criteria it was concluded, that Produkt SPS does not show a skin irritation potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.

Eye irritation:

The potential of the test substance (Produkt SPS) to induce eye irritations was measured with the means of an in vivo test in rabbits (OECD 405 and GLP, Bioassay 2012). Therefore, a single dose of 0.1 ml bulk volume (=18 mg) of the comminuted test item was introduced into the conjunctival sac of the right eye of three rabbits after gently pulling the lower lid away from the eyeball. The lower and upper eyelids were held together for about one second to avoid any loss of test item. Eyes were closely analysed 1, 24, 48 and 72 hrs following administration of the test substance. The following test item-related clinical observations were recorded during the course of the study:

· No reactions at cornea or iris

· Slight conjunctival redness

· Slight conjunctival chemosis

· Slight discharge

· Additional findings like injected scleral vessels in a circumscribed area

The ocular reactions were reversible in all animals within 48 hours after application. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity, 0.0, 0.0 and 0.0 for iris lesions, 0.0, 0.0 and 0.3 for redness of the conjunctiva and 0.0, 0.0 and 0.0 for chemosis.

Considering the described ocular reactions as well as the average score for irritation, Produkt SPS does not show an eye irritating potential under the test conditions chosen.

Justification for selection of skin irritation / corrosion endpoint:
GLP guideline study according to OECD 431/439

Justification for selection of eye irritation endpoint:
GLP guideline study according to OECD405

Justification for classification or non-classification

Based on the available data, the test substance is not classified with regard to skin and eye irritation according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP), respectively.