Registration Dossier

Administrative data

Description of key information

LD50(oral) > 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No information is available on the substance itself, i.e. Solvent Red 008. However, a study on a Read Across substance, i.e. Similar Substance 01, was available and used for the assessment. A detailed description of the read across process was attached in section 13.

Acute oral toxicity to rats of test substance was tested at a concentration of 1000 and 5000 mg/kg. No mortality was recorded and symptoms (dyspnoea, curved position and ruffled fur) disappeared within the 14 -day observation period. Thus, a LD0 of 5000 mg/kg was established.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

 

The oral LD50 value was established to be greater than 5000 mg/kg body weight, therefore the test substance is above the classification threshold for acute oral toxicity (Category 4: 300 < ATE ≤ 2000 mg/kg).