Reaction product of 3,9-dibromobenzanthrone condensed with 2 equivalents of 1-aminoanthraquinone, subsequently further condensed under oxidative conditions

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics, other

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

key study

Study period:

17 October 2016

Reliability:

other: A written assessment based on toxicological profile of the substance

Rationale for reliability incl. deficiencies:

other: See 'Remark'

Remarks:

A written assessment of toxicokinetic behaviour is considered appropriate for the substance. The substance displays only minor toxicological effects in any of the studies proposed, and is deemed to be be not harmful for health effects. As such, it is deemed inappropriate in terms of animal welfare to conduct a toxicokinetic assessment when no harmful effects are predicted based on known toxicology. A written assessment has therefore been prepared to address this endpoint.

Data source

Reference

Reference Type:

other: Assessment of toxicokinetics

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Objective of study:

other: Assessment of toxicokinetic behaviour

Principles of method if other than guideline:

Written assessment based on toxicological profile.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of 3,9-dibromobenzanthrone condensed with 2 equivalents of 1-aminoanthraquinone, subsequently further condensed under oxidative conditions

EC Number:

944-232-9

Molecular formula:

Not available - UVCB substance

IUPAC Name:

Reaction product of 3,9-dibromobenzanthrone condensed with 2 equivalents of 1-aminoanthraquinone, subsequently further condensed under oxidative conditions

Test material form:

solid: particulate/powder

Test animals

Species:

other: Not applicable

Administration / exposure

Details on exposure:

Not applicable

Duration and frequency of treatment / exposure:

Not applicable

Doses / concentrations

Remarks:

Doses / Concentrations:
Not applicable

No. of animals per sex per dose / concentration:

Not applicable

Positive control reference chemical:

Not applicable

Details on study design:

Not applicable

Details on dosing and sampling:

Not applicable

Statistics:

Not applicable

Results and discussion

Metabolite characterisation studies

Metabolites identified:

not measured

Details on metabolites:

Not applicable

Applicant's summary and conclusion

Conclusions:

The following absorption factors will be used for the chemical safety assessment:
Dermal route: 10% (based on molecular weight > 500 and Log Kow > 4)
Oral route: 50% (worst case)
Inhalation route: 50% (worst case)

The substance is not predicted to be bioaccumulative based on the very high log Kow value and low solubility in n octanol.

Executive summary:

No signs of toxicity were observed in the key acute oral toxicity study at a dose level of 2000 mg/kg body weight, however, dark red discoloured faeces and bedding were noted during the first day of the study. In the supporting acute oral toxicity studies, signs of toxicity were observed at dose levels from 4640 mg/kg to 15380 mg/kg body weight. In the oral combined repeated dose toxicity study with the reproduction/developmental toxicity screening study, signs of toxicity were not observed at a dose level of 1000 mg/kg body weight per day, however, orange staining in the cage tray was observed. This staining was considered to be due to excretion of metabolised substance, which indicates that the lower molecular components of this UVCB substance are somewhat absorbed by the oral route. Poor oral absorption of the main component of the substance may be predicted based on its molecular weight, log Kow value and low water and fat solubility. The substance is classified as a skin sensitiser, however, the molecular weight (> 500), high estimated log Kow value (12.23) and poor solubility in water do not favour dermal absorption. No signs of toxicity were observed in an acute inhalation toxicity study conducted with the test material.

The following absorption factors will be used for the chemical safety assessment:

Dermal route: 10% (based on molecular weight > 500 and Log Kow > 4)

Oral route: 50% (worst case)

Inhalation route: 50% (worst case)

There are no data available on the distribution of the substance. The main component of the substance is not absorbed at all, as it is not soluble in water or in organic solvents. The lower molecular components and impurities, which are absorbed, are likely to undergo metabolism to more polar conjugated metabolites, which are then excreted. The results of the in vivo micronucleus study indicate that the substance is not metabolised to genotoxic structures. The substance is not predicted to be bioaccumulative based on the very high log Kow value and low solubility in n octanol.