Registration Dossier

Administrative data

Description of key information

4-anilinobenzenediazonium hydrogen sulphate is skin irritant and it causes serious eye damage.

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 (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion

The skin corrosion potential of the test item 4-anilinobenzenediazonium hydrogen sulphate was assessed with an in vitro membrane barrier assay for skin corrosion according to OECD TG 435. The test item did not show the ability to penetrate the biobarrier during the whole observation interval. Positive and negative control results met the acceptance criteria indicating a good functioning of the test system. 4-anilinobenzenediazoniumhydrogen sulphate is defined as non-corrosive to the skin according to the CLP Regulation (EC. n.1272/2008). Based on WoE approach considering the low pH of water solution or test item , the negative result of skin corrosion test according to OECD TG 435 and the positive result of eye damage test according to OECD TG 437 (BCOP), 4-anilinobenzenediazoniumhydrogen sulphate is classified skin irritant (H315,skin irr. cat.2) according to the CLP Regulation (EC. n.1272/2008).

Eye damage

4-anilinobenzenediazoniumhydrogen sulphate was tested for its eye damage potential with an in vitro test according to OECD TG 437 Bovine Corneal opacity and Permeability test (BCOP). The test item was incubated on the cornea for 4 hours at 32 ± 1 °C and, after removal of the test item, opacity and permeability values were measured. The calculated IVIS value for the test item was 279.76 (> 55) and so it is possible to conclude that 4-anilinobenzenediazonium hydrogen sulphate causes serious eye damage on the cornea of the bovine eye and it is classified H318 (eye damage cat.1) according to the CLP Regulation (EC. n.1272/2008).

Justification for classification or non-classification

The OECD TG 435 " In vitro membrane barrier assay for skin corrosion" allows identification of corrosive chemical substances and mixtures and subcategorisation of corrosive substances. Preliminary tests were performed to determine if the test substance is detectable by detection system and to define the time category for the evaluation of the results. CORROSITEX® test system was suitable for 4-anilinobenzenediazonium hydrogen sulphate and the time category to evaluate the results of the test was time category 2. According to time category 2, a test item is corrosive if its penetration time through the barrier is major than 60 minutes. The penetration time for 4-anilinobenzenediazonium hydrogen sulphate was major than 65 minutes and it is not classified as skin corrosive. Based on WoE approach considering the low pH of water solution of test item , the negative result of skin corrosion test according to OECD TG 435 and the positive result of eye damage test according to OECD TG 437 (BCOP test), 4-anilinobenzenediazoniumhydrogen sulphate is classified skin irritant (H315, skin irr. cat.2) according to the CLP Regulation (EC. n.1272/2008).

According to OECD TG 437 Bovine Corneal Opacity and Permeability (BCOP) Test, a substance with an IVIS > 55 induces serious eye damage and it is classified UN GHS Category I or H318 (eye damage cat.1) according to the CLP Regulation (EC n.1272/2008). IVIS of 4-anilinobenzenediazoniumhydrogen sulphate is 279.76 and it satisfies the criteria for the classification H318 (eye damage cat.1) according to the CLP Regulation (EC n.1272/2008).