Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Oral LD50 (rat) > 2000 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 adverse effect observed

Additional information

ORAL ROUTE

There are no information about the acute oral toxicity of Acid Red 336, thus the available data on structural analogous Similar Substance 01 have been taken into account (details and explanations are included in the report attached to the IUCLID section 13).

In the study on similar substance 1, performed according to the OECD Guideline 401, following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material, as a suspension in distilled water at a dose level of 2000 mg/kg bw. No deaths occurred during the experiment. Red-coloured diarrhoea was noted in all males and two females four hours after dosing. No other signs of systemic toxicity were noted. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy.

Justification for classification or non-classification

The oral LD50 value was established to be greater than 2000 mg/kg, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity category 4: 300 < ATE ≤ 2000 mg/kg bw).