Registration Dossier

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.