Registration Dossier

Administrative data

Description of key information

Acute Oral Toxicity

LD50 between 300 and 2000 mg/kg bw

Acute Dermal Toxicity

LD50 > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
300 mg/kg bw
Quality of whole database:
LD50 between 300 and 2000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

There is no relevant information about the acute toxicity of Direct Violet 051, therefore, the available data on structural analogous Similar Substance 01 have been taken into account. The read across approach can be considered as reliable and adequate for the purpose; details and explanations are detailed in the report attached to the IUCLID section 13.

Acute Oral Toxicity

In the key study, carried out on Similar Substance 01, female rats received a single dose of 2000 (1 female) and 300 mg/kg bw (5 females) by gavage. Rats were observed for 14 days thereafter. The female at 2000 mg/kg bw died within one day after dosing showing reduced body weight, purple staining of the urine and abnormally red lungs, dark liver, dark kidneys, dark purple coloured substance present in the stomach and purple colored staining of the small intestine. Females at 300 mg/kg did not show any effects on body weight, clinical signs and macroscopic investigations. The faeces of 4 of these females was purple stained. Based on these findings the oral LD50 of the substance is between 300 and 2000 mg/kg bw.

Two supporting studies carried out on the Target Substance gave as result LD50 values > 5000 mg/kg bw in both cases. However the information coming from this two studies is not sufficient for classification purposes as the content of test item in the substance tested is low.

Acute Dermal Toxicity

In a test according to OECD 402 Wistar rats (5/sex) received 2000 mg/kg bw of the test substance on the skin during 24 hours. During the 14 day observation period no mortality and clinical signs were observed. Body weight was in normal ranges except for one female. Another female developed scabs. No abnormalities were found at necropsy. The LD50 of the substance is > 2000 mg/kg bw.

Justification for classification or non-classification

Based on the available information the substance needs to be classified as harmful after oral exposure (H302, harmful if swallowed) according to Regulation (EC) No 1272/2008 (CLP)