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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

The acute oral toxicity of the substance was evaluated by considering data on the substance itself as well as data on Similar Substance 01 following a weight of evidence approach. This decision was made considering the low purity of both test items used experimentally, the high similarity between the substances and the coherence in results. Justification for the use of a Read Across approach is provided in Section 13 of IUCLID.

The acute oral LD50value of the test item in rats was estimated to exceed 5000 mg/kg bw in an experimental study on rats. However, due to the lack of testing procedure information, documentation is insufficient for assessment and thus the reliability of the data cannot be assigned.

The acute oral toxicity of Source Substance 01 was evaluated in an experimental study on Sprague-Dawley rats, according to an internal method similar to the OECD Guideline 401. Based on the results of the preliminary study, five males and five female rats were administered 5 g/kg bw of Source Substance 01 in aqueous methyl cellulose (1 %) by oral gavage. A vehicle control group of five males and five females was treated with vehicle alone. Clinical signs and mortality were recorded during the observation period of 14 days. Thereafter, all animals were subjected to a macroscopic examination.

No mortalities were observed in the main test. The LD50value of Source Substance 01 to rats, and therefore of the test item, was found to be greater than 5000 mg/kg bw.

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 the numeric criteria.

Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

In the case of oral exposure route, the acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories are:

-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

 

Based on the oral LD50 value obtained in an experimental study on rats using a structural analogue (Source Substance 01), the test item is not classified as harmful/toxic according to the CLP Regulation (EC no. 1272/2008).