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 key studies on dermal penetration (OECD method 428, GLP compliant Klimisch 1) (GLP compliant, Klimisch 1), the absorbed dose (recetor fluid, epidermis and dermis) was 0.11 µg/cm2 equivalent to 0.53±0.33% of the applied dose. The substance had a very low absorption rate. However, the registered substance led to systemic exposure after oral gavage, in basic toxicokinetics study (OECD Guideline 474 method).

Key value for chemical safety assessment

Absorption rate - dermal (%):

0.53

Additional information

Two studies were available to assess toxicokinetic properties of the test substance Acid Violet 43.

-In the first key study (OECD 428 method, GLP compliant, Klimisch 1), human skin samples were used from female donors subjected to plastic surgery. Skin samples were dermatomed and mounted in diffusion cells. After exposure period, the remaining formulation on the skin surface was removed using a standardized washing procedure. Twenty four hours after application, the percutaneous absorption of Jarocol Violet 43 was estimated by measuring its concentration by LC/MS/MS in the following compartments: skin excess, stratum corneum (isolated by tape strippings), epidermis + dermis and receptor fluid. The 0.53% diffusion of the test item in receptor fluid showed a very low absoprtion of the test item. (Guidicelli 2002 ; Wollny 2001)

-In the second key study (OECD 474 method, GLP compliant, Klimisch 1), 3 rats per sex and per time point group were dosed orally by gavage. At 15 minutes, 30 minutes and 1 hour, blood was sampled in orbital sinus. Serum was isolated and deproteinzed. The amount of the test item was measured by a HPLC-UV method and calculated by interpolation with a calibration curve (made with known concentration curve) by linear regression analysis with the serum blood samples.

Under experimental conditions of this study, the Acid Violet 43 after oral gavage at 2000 mg/kg was found in serum of treated rats at each time point samples. The study showed a systemic exposure of test item to the rats after oral gavage. (Haddouk 2007). Furthermore, subchronic repeated dose toxicity study was performed on rats which were treated by gavage. The treatment induced toxicity and revealed systemic exposure by the test item which could go across the gastrointestinal tract. (Golfain, 2004, Klimisch 1)