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Administrative data

Description of key information

Acute toxicity in rats

LD50 > 2000 mg/kg

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

In the assessment of acute oral toxicity, available data on target substance itself and on a read-across substance, i.e. Similar Substance 01, was used. Further details on the read across are reported in section 13.

In both studies, samples with low purity were tested. Apart from the dye, remaining components were mainly dispersants, salts and water. Due to the lack of details on test method and results, available data on target substance was used only as supporting evidence, while the study report on Similar Substance 01 was taken as key study for the assessment.

Rats were dosed with 5000 mg/kg of Similar Substance 01 (purity 34.5 %) by gavage in a limit test. No mortality was recorded, thus no LD50 could be established.

A sample of target substance (purity 24 %) was administered to rats as a single oral dose; a 14 -day observation period followed. Mortality was seen and allowed to establish a LD50 value between 6800 and 10000 mg/kg.

A further data on target substance was availaible; in particular, LD50 of 3840 mg/kg was found using a sample with 18 % dye content. Due to the low purity and the lack of details, such study was only reported as a confirmatory evidence.

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 oral, dermal or inhalation route according to numeric criteria. Acute toxicity values are expressed as LD50 (oral, dermal) or LC50 (inhalation) values as well as acute toxicity estimates (ATE).

 

In available studies in rats, oral LD50 values above 2000 mg/kg bw were found. Accordingly, target substance was not classified for acute oral toxicity in the CLP Regulation (EC 1272/2008).