Reaction mass of 1,2-Benzenedicarboxylic acid, 3-sulfo-, ammonium salt (1:3), 4-Sulphophthalic acid, ammonium salt, Ammonium sulphate

Endpoint summary

Description of key information

Skin irritation (OECD 431/439): not irritating (BASF, 2012)
Eye irritation (OECD 405): 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 Decaltal N to cause dermal corrosion/irritation was assessed by a single topical application of 25 μL bulk volume (about 13 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 test substance 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 93%, and it was 96% 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 123%. Due to very high OD values of the test substance, distinctly exceeding the OD values of the negative control, another test run of the EpiDerm™ skin irritation test was performed. The mean viability of the test-substance treated tissues for the 2nd test run was 106%. All acceptance criteria were met. Based on the observed results and applying the evaluation criteria it was concluded, that Decaltal N does not show a skin irritation potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.

Eye irritation:

The potential of Decaltal N to cause damage to the conjunctiva, iris or cornea was assessed according to OECD guideline 405 by a single ocular application of 0.1 bulk volume (about 16 mg) of the comminuted test item to one eye of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing two additional animals). About 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application. The following test item-related clinical observations were recorded during the course of the study:

· slight conjunctival redness

· slight conjunctival chemosis

· slight or obvious discharge

· Additional findings like injected scleral vessels in a circumscribed or circular area

The ocular reactions were reversible in all animals within 72 hours after application at the latest. 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 0.7 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, Decaltal N does not show an eye irritating potential under the test conditions chosen.

Justification for classification or non-classification

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