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

Endpoint summary

Description of key information

The registered item Acid Violet 43 is not classified as acute oral hazard according to the key study (GLP, OECD Guideline 401 followed, Klimisch 2) and the CLP regulation.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Additional information

Four studies were available for acute oral toxicity assay. Three were performed on rats by oral gavage and the last was performed on dogs which is unrelevant for CLP classification. However one was considered as key study (Klimisch 2, OECD guideline 401, Rondot 1984).

- In this study, the registered substance was administered orally on male and female rats (2 for preliminary study and 5 for the main study per sex) per dose group (gavage) at 1000, 2000 and 5000 mg/kg bw in preliminary study and 0 and 5000 mg/kg bw were used for the main study (limit test). The Acid Violet 43 was in suspension in deionized water. The registered substance induced no mortality at each dose level. The Lethal Dose 50 value was defined as greater than 5000 mg/kg bw on rats by oral gavage.

-In the two others study (considered as supporting study due to uncomplete informations, Klimsch 3), rats were administered with test item at 464, 2150, 4640 mg/kg and no mortality occured (Scala, 1962, No GLP, non standard method). The second supporting study (Coquet, 1976, Non GLP compliant, non standard method) showed mortality at 10 000 mg/kg bw to 20 000 mg/kg bw in rats by oral gavage, the LD50 value was defined as 13 000mg/kg bw for this study.

Justification for classification or non-classification

According the results of the key study, the LD50 value was considered as greater than 5000 mg/kg bw. According to CLP regulation, the register substance Acid Violet 43 was not classified for Acute Oral Toxicity.