Registration Dossier

Administrative data

Description of key information

Due to in vitro test results 4-nitrotoluene-2-sulphonic acid is considered to bi irritating to the skin and to cause serious damage to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation /corrosion

4-nitrotoluene-2-sulphonic acid was irritating to the skin in the Epiderm TM Skin Corrosion/Irritation Test (OECD 431) (BASF SE, 2010). For the corrosion test the samples were incubated with the test substance for 3 minutes and 1 hour, for the irritation test the samples 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 acitvity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reducted formazan production after incubation with a tetrazolium salt (MTT) was chosen as suitable endpoint.

The mean viability of the test substance treated tissues determined after an exposure period of 3 minutes was 101%, and it was 17% after an exposure period of 1 hour.The mean viability of the test-substnce treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 7%.

Eye irritation

4-nitrotoluene-2-sulphonic acid causes serious eye damage in the Bovine corneal Opacity and Permeabilit Tet (OECD 437) (BASF SE, 2010). Corneal opacity was measured quantitatively as the amount of light transmission through the cornea. Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. The mean Opacity change of the test-substance treted corneas was 143.4. The mean OD490 of the test-substance treateed corneas determined as permeability parameter was 0.013. The In Vitro Irritancy Score (IVIS) of the test-substance treated corneas was calculated to be 143.6 .


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: corrosive

Justification for classification or non-classification

EU classification according to Annex VI of the Directive 67/548/EEC:

- risk of serious damage to eyes, R 41

- irritating to skin, R 38

GHS classification (EU GHS, CLP 1272/2008)

- serious eye damage, category 1

- skin irritation, Category 2