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Description of key information

Non toxic by oral and dermal route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
15 000 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 adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

No data on Acid Yellow 049 sodium salt is available. Therefore, available data on the acid form was used. Details on the read acorss approach are reported in section 13.

Oral route

Two acute oral toxicity tests have been performed on Acid Yellow 049, acid form; the salification is not expected to significantly impact the acute oral toxicity potential.

In the key study (1994), the acute oral toxicity potential of the substance has been assayed following the testing procedures outlined into the OECD guideline 401. The substance was administered, as water solution, by gavage to 5 rat/sex; a single dose of 15000 mg/kg was given. Throughout the experiment no clinical symptoms of intoxication were observed. Main observations were:

- lungs: pinkish colour, spongy, airy, without macroscopic pathomorphological changes;

- heart: maroon, with stiffer consistency, without macroscopic pathomorphological changes.

- liver: dark reddish-brown color, smooth surface, stiffer consistency.

- spleen: reddish-brown color, stiffer consistency, without macroscopic pathomorphological changes.

- kidney: maroon on a smooth surface, stiffer consistency, without macroscopic pathomorphological changes.

- head, neck, stomac, gut and bladder did not show macroscopic pathomorphological changes.

The LD50 resulted to be greater than 15000 mg/kg.

A second experiment (1976) was available on Acid Yellow 049, acid form: 5000 mg/kg of test item were administered to rats, as aqueous solution; no death occurred and no poisoning symptoms were recorded. Only a summary sheet was available, thus details on testing procedures and results were lacking.

In conclusion, Acid Yellow 049 is expected to be non harmful/toxic if swallowed.

Dermal route

An acute dermal toxicity tests has been performed on Acid Yellow 049, acid form; the salification is not expected to significantly impact the acute oral toxicity potential.

The acute dermal toxicity potential of the substance has been assayed following the testing procedures outlined into the OECD guideline 402. The substance was administered, as paste, by occlusive application on 6 rats; a single dose of 5000 mg/kg was given. Throughout the experiment no clinical symptoms of intoxication were observed. Visual check revealed that coat, skin and visible mucous membranes appeared without abnormalities. It was also found good nutritional status, normal mental and motor activity, reactivity and sensibility. Functionality of the circulatory, respiratory, digestive and urogenital apparatus resulted to be normal. Subcutaneous tissue and muscle, head, neck, stomac and intestine did not show macoscopic patomorfological changes.

The LD50 resulted to be greater than 5000 mg/kg.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.1 Acute toxicity 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. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

The oral LD50 value was established to be greater than any classification limit for acute oral toxicity (oral acute toxicity category 4: 300 < ATE ≤ 2000 mg/kg bw).

The dermal LD50 value was established to exceed the highest CLP classification limit (dermal acute toxicity category 4: 1000 < ATE ≤ 2000 mg/kg bw).

In conclusion, the substance does not meet the criteria to be classified for oral and dermal acute toxicity, according to the CLP Regulation (EC 1272/2008).