Registration Dossier
Registration Dossier
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EC number: 943-290-2 | CAS number: -
Endpoint summary
Administrative data
Description of key information
LD50, oral, rat, 14 days: > 5000 mg/kg bw
LD50, inhalation: not available
LD50, dermal: not available
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
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 toxicity assessment has been based on the Read Across approach:
Acid Red 249:1 is a multiconstituent substance composed by the acidic and the sodium salt forms of the same structure (72.7 % and 14.95 % of the substances respectively).
The tests was performed on the Similar Substance 01 which is the major component of the multiconstituent substance. Considering the high similarity between the structures and the composition of the substance the Read Across approach is considered as acceptable. See section 13.
Acute Oral
The oral toxicity of the substance was determined, but no guideline is available and the test was not performed on GLP. The test substance was tested in a single dose (5000 mg/kg bw) on rats. The animals were observed for 14 days.
The acute oral median lethal dose LD50 in rats in > 5000 mg/kg body weight.
No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.
Acute inhalation
No study available
Acute dermal
No study available
Based on the test conducted on Similar Substance 01, even the Acid Red 249:1 is expected to have an LD50 > 5000 mg/kg bw
Justification for selection of acute toxicity – oral endpoint
The study has been conducted on the major component of the multiconstituent substance
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008), 3.1.2.1 section, 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 shown in Table 3.1.1:
Oral (mg/kg bodyweight)
Category 1: LD50 ≤ 5
Category 2: 5 <LD50 ≤ 50
Category 3: 50 < LD50 ≤ 300
Category 4: 300 < LD50 ≤ 2 000
The acute oral median lethal dose LD50 in rats is expected to be > 5000 mg/kg body weight.
The substance is not classified for acute toxicity because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008.
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