Registration Dossier

Administrative data

Description of key information

LD50 (oral) > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

ACUTE TOXICITY - ORAL ROUTE

A good GLP study on similar substance 01, performed according to the OECD Guideline n. 401 is available. The study was

performed to assess the acute oral toxicity of the substance following a single oral administration in the

Wistar rat. The test material was administered by gavage in tap water. There were no deaths. No clinical

signs has been observed. Individual body weights changes were normal and individual necropsy revealed

no abnormalities.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/200/) Table 3.1.1, substances can be allocated to one of four toxicity categories based on acute toxicity.

For the oral route of exposure the Acute Hazard Categories are defined by means of the Acute Toxicity Estimate (ATE) values:

Category 1: ATE ≤ 5 mg/kg bw

Category 2: 5 < ATE ≤ 50 mg/kg bw

Category 3: 50 < ATE ≤ 300 mg/kg bw

Category 4: 300 < ATE ≤ 2000 mg/kg bw

Since the ATE value associated to the substance is > 2000 mg/kg bw therefore no classification is warranted for the dyestuff for acute oral toxicity.