Tetralithium 5,5'-[vinylenebis[(3-sulphonato-4,1-phenylene)azo]]bis[3-methylsalicylate]

Endpoint summary

Link to relevant study record(s)

Reference

Endpoint:

basic toxicokinetics, other

Remarks:

Toxicokinetic Assessment

Type of information:

other: Toxicokinetic Assessment

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other:

Remarks:

The assessment of the toxicokinetics is based on physico-chemical properties and toxicological data. Experimental toxicokinetic studies were not performed.

There are no experimental toxicokinetic data available for the substance and this statement is based on the available physico-chemical and toxicological data. This comprises inter alia studies on skin irritation/corrosion, eye irritation, skin sensitization, in vitro mutagenicity and acute and repeated dose oral toxicity. The assumption on toxicokinetics follows the procedure indicated in the “Guidance on information requirements and chemical safety assessment chapter R.7c” of the ECHA guidance document (version 3.0, June 2017).

Additional information

There are no experimental toxicokinetic data available for the substance and this statement is based on the available physico-chemical and toxicological data. This comprises inter alia studies on skin irritation/corrosion, eye irritation, in vitro mutagenicity and acute and repeated dose oral toxicity. The assumption on toxicokinetics follows the procedure indicated in the “Guidance on information requirements and chemical safety assessment chapter R.7c” of the ECHA guidance document (version 3.0, June 2017).

Available physico-chemical information taken into account:

Physical appearance: Tetralithium 5,5'-(vinylenebis((3-sulphonato-4,1-phenylene)azo))bis(3-methylsalicylate) is marketed as aqueous solution. The substance itself appears as orange to brown solid (powder).

Vapour pressure: Negligible for the solid

Particle size distribution: No data available

Log Pow: -4,04

Molecular weight: 720.4 g/mol

Water solubility: 240 g/L

Estimation of oral absorption: The high molecular weight is not favourable for oral absorption, but the high water solubility contradicts this assumption. Based on the available repeated dose feed study with the substance (OECD guideline 407) an absorption during gastrointestinal passage is indicated by the finding “hyaline droplets” in the rat kidney at the highest concentration tested. This finding is considered to represent a male rat specific systemic effect, thus absorption and distribution of the substance must have previously been occurred.

Estimation of dermal absorption: Dermal absorption is not likely based on the relatively high molecular weight does not favour dermal uptake. Other parameters relevant for dermal absorption: The substance is not irritating to the skin, thus it does not affect the skin barrier.

Estimation of absorption via inhalation: Vapour pressure is considered negligible for the solid. No acute inhalation toxicity study is available to estimate potential absorption via lung.

Overall estimation of absorption: Some absorption is anticipated by oral, dermal and inhalation route.

Estimation of distribution: Based on the high water solubility it is likely that the substance will distribute into the body.

Estimation of accumulation: In general highly water soluble particles have a low potential to accumulate in tissue. Also the log Pow is indicative for a low accumulation potential.

Estimation of metabolism: In vitro genotoxicity data do not indicate the generation of DNA-reactive metabolites due to hepatic biotransformation, since the substance revealed negative results in the available in vitro genotoxicity tests (Ames test, HPRT, MNT in vitro), conducted in the absence and in the presence of a metabolising system.

Estimation of excretion: The finding “hyaline droplets” in the rat kidney revealed in a repeated dose feed study at the highest concentration tested is considered to represent a male rat specific systemic effect, thus urinary excretion is suggested. Also the water solubility is favourable for urinary excretion.