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EC number: 269-950-3
CAS number: 68391-42-4
Acute toxicity in rats
LD50 > 2000 mg/kg
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.
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
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