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Description of key information

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

Fluorescent Brightener 363 is a yellow organic powder, characterized by carries ionic charges.

 

The substance is expected to possess a low potential for bioaccumulation, based on the screening evaluation taken into account the experimental log Pow. Due to the hydrophilicity of the compound and the log P, absorption by passive diffusion may be limited by the rate at which the substance partitions out of the gastrointestinal fluid.

 

Fluorescent Brightener 363 is not toxic/harmful for short-term exposures; it is not skin irritating and it is not able to cause skin sensitization. However, Fluorescent Brightener 363 is able to cause skin irritation. No genotoxic activity has been observed in specific experiments performed. The subacute repeated dose toxicity and the screening on reproductive toxicity study did not evidence any reason of concern.

 

There is no specific studies or specific literature data on toxicokinetics and metabolism, thus available information about the substance and analogues has been taken into account, avoiding further tests.

 

Because of the physical state and the physicochemical properties of Fluorescent Brightener 363, inhalation and dermal absorption is expected to be low. 

 

During the acute oral toxicity experiments, the treatment at high dosages induced signs of reaction recorded were sedation, dyspnoea, curved position and ruffled fur, which may be attributable to the high dosage administered, rather than test item.

During the subacute oral test, no significant effect due to the treatment with Fluorescent Brightener 363 was recorded, up to the appreciable high dose of 750 mg/kg bw/day; one of the explanation may be the limited absorption of the substance, due to the high solubility in water and the low Pow.

In addition, the sulphonation degree is expected to contribute to increased solubility and to decreased absorption.

 

Although on the basis of the available information a definitive conclusion about possible metabolism and metabolites cannot be traced, neither from qualitative, either from rate point of view, the absence of significant effects directly attributable to the test item administration lets to suppose that only few rates of substance can be absorbed or that it can be metabolised into a easily eliminable compound(s). In any case, processes of bioactivation, which may increase the substance toxicity, can be excluded.