Sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate

Endpoint summary

Description of key information

According to the results of the two key studies (Klimisch 1, OECD Guideline 439 Method, Warren, 2014) (Klimisch 1, OECD Guideline 437 Method, Warren, 2017), the registered substance Acid Violet 4 was considered as Not Classified for Skin Irritation based on GLP criterias. Concerning Eye Irritation, the substance was classiffied as Category 1 EU-CLP.

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:

adverse effect observed (irritating)

Additional information

One key study was available to assess the skin irritation potential of the substance (OECD Guideline 439 Method, Klimisch 1, GLP, Warren, 2014):

The purpose of this test was to evaluate the skin irritation potential of the test item using the EpiSkinTM reconstructed human epidermis model for a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours. Additional non-viable tissues were incorporated into the testing for correction purposes to MTT interferences (Water-killed tissues). At the end of the exposure period each tissue was rinsed before incubating for 42 hours and incubation period each tissue was taken for MTT-loading. The relative mean viability of the test item treated tissues was 96.1% after the 15-Minute exposure period and 42-Hours post-exposure incubation period. Under the experimental conditions of the study, incubation of the registered substance Acid Violet 43 led to a relative mean viability at 63.3% compared to negative control. Hence, the registered substance was classified as Non-irritant (EU CLP Not classified for Irritation).

One key study was available to assess the eye irritation potential of the substance (OECD Guideline 437 Method, Klimisch 1, GLP, Warren, 2017):

The purpose of this study was to identify Acid Violet 43 eye effect that can induce serious eye damage using OECD Guideline 439 method for Bovine Corneal Opacity and Permeability Assay (BCOP).

The test item was applied at a concentration of 20% w/v in 0.9% w/v sodium chloride solution for 240 minutes. Negative and positive control items were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS). Histopathological evaluation of the corneas at the end of the treatment was performed as an additional endpoint. Histological evaluation revealed that the test item induced much loss of the epithelium and any remaining cells were necrotic. The In Vitro irritancy score for the test item, 68.1.

Under the experimental condition of the study, the registered substance Acid Violet 43 induced an in vitro irritancy score of 68.1 and histopathology showed necrosis to all cell layers of the cornea. Hence, the test substance was classified as Category 1 for Eye Irritation, causes serious eye damage according CLP regulation.

Justification for classification or non-classification

According to the results of the two key studies (Klimisch 1, OECD Guideline 439 Method, Warren, 2014) (Klimisch 1, OECD Guideline 437 Method, Warren, 2017), the registered substance Acid Violet 4 was considered as Not Classified for Skin Irritation based on GLP criterias. Concerning Eye Irritation, the substance was classiffied as Category 1 EU-CLP H318 "cause serious eye damage" due to loss of epithelium seen in hispathology and high IVIS value of 68.1 on the BCOP assay.