Registration Dossier

Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics, other
Type of information:
other: statement
Adequacy of study:
key study
Study period:
2018
Reliability:
2 (reliable with restrictions)

Data source

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Production date 2014
Expiry date > 2019
Storage tightly closed, dry /dry air, well-ventilated place. No direct sunlight

Results and discussion

Applicant's summary and conclusion

Executive summary:

The substance is a black brown organic solid, used in powdered form, which resulted non-toxic for all of the evaluated end-points: it is not classified according to the CLP Regulation n. 1272/2008, resulted not skin and eye irritant, not toxic/harmful for short, long-term exposures, not sensitizing and it does not show any CMR activity, nor potential effects.

Considering the high molecular size > 700 and the hydrophilic behaviour, it is probable that dermal absorption does not occur and test and the substance it is not harmful for the dermal route. Moreover, the substance is characterized by inhalable particle (TFL, 2016), but not respirable, therefore, inhalation is expected to be an unlikely route of absorption.

The water solubility suggests that it is a hydrophilic substance, thus it is expected that only a small rate of substance as such could be absorbed by oral route.

Repeated oral administration on Similar substance 01 (OECD422) did not cause any mortality related to the dose but only accidental; no negative treatment related effects were detected during functional observation of animals.

Azo dyes are highly water soluble and do not tend to accumulate in the body. Thus, it is likely that their toxicity might not be due to the dye itself, but rather to degradation metabolism of the dyes. Some azo dyes undergo to the formation of aromatic amine metabolites by metabolism and this represents a risk; nevertheless, note that some characteristics of the substance may influence the susceptible of cleavage, example sulphonation of azo dyes may inhibit the release of aromatic amines.

Sulphonation of azo dyes appears to decrease toxicity by enhancing urinary excretion of the dye and its metabolites, as apolar and flat aromatic amines are not formed, but rather sulphonated aromatic amines soluble. Therefore, the nature of these metabolites is not dangerous both for reasons of absorption end of specific interaction.