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Administrative data

Link to relevant study record(s)

Description of key information

The substance is distributed in the animal body by systemic way (oral and dermal route) with possible accumulation potencial based on substance Kow . After subacute repeated dose aplication the effects occur on haematological parameters (anaemia) and biochemical parameters (influence to liver metabolism and urinary system function) and could be distributed through placenta.

Key value for chemical safety assessment

Additional information

Experimental toxicokinetics studies are not available. Assessment of the toxicokinetic behavior of the substance was performed following the relevant available information.

 

The evaluation of toxicokinetics is based on information from following sources:

 - Experimental data of toxicological tests

 - Literature data

 - Data from toxicological databases – free and commercial

After single oral application to rats the substance was absorbed through digestive tract and distributed as itself or metabolites to the skin, fur, visible mucous membranes, subcutaneous and skeletal muscle and deposited in fatty tissue . The substance and /or its metabolites caused dark colour of urine in female rats. So the substance is distributed in the animal body by systemic way.

 

After single dermal application of high dose (2000 mg/kg) of the substance to male and female rats, the substance penetrated through the skin and it was distributed to the fatty tissue. The females seem to be more sensitive. Because of mild character of clinical and macroscopic effects it was concluded that they did not influence the classification of the test substance. But no symptoms of systemic toxicity were observed in the rabbit during the test period after single application 0,5 ml of the Solvent Yellow 124 onto clipped skin.

This result could be caused by application of much smaller dose or by interspecies difference.

 

The substance is a skin sensitizer in mice. The irritation potential of the test substance was found out after application on ears of mice. This fact pointed to absorption of the substance to the mice organism after dermal exposure.

 

After single application of the substance to conjunctival sac of the rabbit eye the test substance did not demonstrate local irritating effects of eye and systemic toxic effects. It seems that the substance does not penetrate to the body after acute eye exposure.

 

Based on experimental results of long term repeated administration of Solvent Yellow 124 it is possible to conclude that the substance is probably absorbed from gastrointestinal tract and distributed throughout the body of experimental animals to relatively distant compartments, what is demonstrated by the effects on haematological parameters (anemia) and biochemical parameters (influence to liver metabolism and urinary system function) .

        

Results of Reproduction/Developmental Toxicity Screening Test in rats revealed that the substance at the high dose caused decrease of total number of live pups and mean number of pups per litter. The pups showed yellow colour of fatty tissue, subcutis and milk in stomach. This is the evidence that substance could be distributed through placenta.

 

No data about metabolism and excretion of the evaluated substance were found.