Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics, other
Remarks:
toxicokinetic Assessment
Type of information:
other: toxicokinetic Assessment
Adequacy of study:
weight of evidence
Reliability:
other:
Rationale for reliability incl. deficiencies:
other: toxicokinetic assessment based not on specific toxicokinetik data but on the available experimental data

Data source

Reference
Reference Type:
other: toxicokinetic assessment
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Any other information on results incl. tables

There are no experimental toxicokinetic data available for the substance and this statement is based on available data as physico-chemical data and toxicological data like skin irritation/corrosion, eye irritation, skin sensitization, in vitro mutagenicity and acute and repeated dose oral toxicity studies. This assumption follows the procedure indicated in the “Guidance on information requirements and chemical safety assessment chapter R.7c” of the ECHA guidance document (version 1.1, November 2012).

Available physico-chemical information taken into account:

Physical state:

The dyestuff itself is an organic solid but could only be handled as an aqueous solution with 58.8% water.

The boiling point is 101.8°C at 1013 hPa.

Particle size distribution:

No data available

Structure:

Bayscript Blaukomponente; Reaction mass of 2,7-Naphthalenedisulfonic acid, 5-amino-3-[[4-[2-[4-[(7-amino-1-hydroxy-3-sulfo-2-naphthalenyl)azo]-2-sulfophenyl]ethenyl]-3-sulfophenyl]azo]-4-hydroxy-, lithium sodium salt, compd. with 2,2'-(methylimino)bis[ethanol] and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[6-amino-4-hydroxynaphthalene-2-sulphonic] acid, lithium sodium salt , compound with 2,2'-(methylimino)diethanol

Molecular weight:

UVCB

Water solubility:

Highly soluble; the substance is an aqueous solution and only marketed and used with a content of 58.8% water. Therefore, it can be concluded that the substance has high water solubility.

Log Pow:

The partition coefficient was estimated from QSAR calculations for the three main components of the substance and determined to be in the range of 1.82 - 3.72.

Surface tension:

The surface tension of the substance is 58.49 mN/m at 20°C.

Vapor pressure:

Anticipated to be low and estimated by QSAR for the three main components of the substance and determined to be 0 Pa at 25 °C.

Estimation of oral absorption:

Oral absorption can be assumed, based on the physico-chemical data: soluble in water, log Pow for the three main components of the substance in the range of 1.82 - 3.72.

An oral sub-acute toxicity study was performed according to OECD guideline 407. Treatment with Bayscript Blaukomponente resulted in several findings which were related to the color of the test substance. The whole body and several organs of animals treated with 1000 mg/kg bw/day appeared discolored. Colored kidneys were observed starting at 300 mg/kg b.w./day indicating the UVCB substance is absorbed at this dose.

Overall: oral absorption is assumed based on physicochemical properties and oral toxicity experiments.

Estimation of dermal absorption:

Dermal absorption is likely based on log Pow for the three main components of the substance in the range of 1.82 - 3.72. Surface activity is above 10 mN/m (58.49 mN/m at 20°C) and consequently not in favor of extensive dermal absorption.

Dermal toxicity data does not indicate relevant dermal absorption:

Skin irritation: Not irritating and no systemic effects

Skin sensitization: Negative in LLNA

Dermal toxicity data: Bayscript Blaukomponente (konserviert) was applied dermally to the shorn back and flank of groups of male and female Wistar rats at a dose of 2000 mg/kg bw under semi-occlusive conditions (OECD TG 402). After approximately 24 hours the dressings were removed and the area was rinsed with tepid water using soap and gently patting the area dry. The dose of 2000 mg/kg bw was tolerated by male and female rats without mortalities or toxicolological relevant clinical signs. No adverse effects on body weight development in males and females nor gross pathological findings were observed.

Overall: some dermal absorption might be assumed.

Estimation of absorption via inhalation:

Vapor pressure is anticipated to be low and estimated by QSAR for the three main components of the substance to be 0 Pa at 25 °C; no information on particle size distribution is available. No acute inhalation toxicity study is available to estimate potential absorption.

Overall: absorption by inhalation might be assumed but vapor pressure is low.

Overall estimation on absorption: some absorption is anticipated by oral, dermal and inhalation route and similar absorption values were taken for all routes in the DNEL calculations.

Estimation of distribution:

Based on the log Pow (1.82 - 3.72) and the high solubility in water it is likely that the substance distributes into cells. This assumption is supported by the oral sub-acute toxicity study in which the whole body and several organs of animals treated with 1000 mg/kg bw/day appeared discolored. Colored kidneys were observed starting at 300 mg/kg b.w./day indicating the UVCB substance is distributed into kidneys at this dose.

Estimation of accumulation:

Highly water soluble particles have a low potential to accumulate in tissue.

Estimation of metabolism:

In vitro genotoxicity data do not indicate any genotoxic metabolites. The substance is negative in the absence and in the presence of S9 extracts (Ames test and in-vitro Chromosome Aberration test).

Estimation of excretion:

Blue feces observed in the sub-acute toxicity study. At clinical observations a bluish discoloration on the whole body was noted for animals treated at 1000 mg/kg b.w./day.

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Dr. Dieter Beyer

Regulatory Toxicology

Applicant's summary and conclusion