Registration Dossier
Registration Dossier
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EC number: 265-334-3 | CAS number: 65059-45-2
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: predicted data
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- none
- GLP compliance:
- no
Test material
- Reference substance name:
- 4,11-diamino-2-[3-(2-methoxyethoxy)propyl]-1H-naphth[2,3-f]isoindole-1,3,5,10(2H)-tetrone
- EC Number:
- 265-334-3
- EC Name:
- 4,11-diamino-2-[3-(2-methoxyethoxy)propyl]-1H-naphth[2,3-f]isoindole-1,3,5,10(2H)-tetrone
- Cas Number:
- 65059-45-2
- Molecular formula:
- C22H21N3O6
- IUPAC Name:
- 4,11-diamino-2-[3-(2-methoxyethoxy)propyl]-1H,2H,3H,5H,10H-naphtho[2,3-f]isoindole-1,3,5,10-tetrone
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: none
- Strain:
- other: none
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- none
Administration / exposure
- Route of administration:
- other: none
- Vehicle:
- other: none
- Details on exposure:
- none
- Duration and frequency of treatment / exposure:
- none
Doses / concentrations
- Remarks:
- Doses / Concentrations:
none
- No. of animals per sex per dose / concentration:
- none
- Control animals:
- not specified
- Positive control reference chemical:
- none
- Details on study design:
- none
- Details on dosing and sampling:
- none
- Statistics:
- none
Results and discussion
- Preliminary studies:
- none
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The low water octanol/water partition coefficient value (Log10 Pow1.78), indicates insolubility in water and particle size indicates the substance is not available as a vapour therefore inhalation is not a significant route of exposure. In the single dose toxicity study there was no evidence of test item absorption.
- Details on distribution in tissues:
- Neither the physico-chemical properties nor the available toxicological information provided any indication of a mechanism for distribution. It is possible that only a very small amount of the test substance or coloured metabolites lead to the appearance of the blue/black stained faeces detected in single dose rodent toxicity study.
- Details on excretion:
- Poor water-soluble products are not favourable for urinary excretion and therefore excretion as demonstrated in the single dose rodent toxicity study is most likely to be in the faeces.
Metabolite characterisation studies
- Metabolites identified:
- not measured
- Details on metabolites:
- There is no evidence suggesting that the test substance may be metabolised, however no studies have been conducted to identify metabolites.
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- none
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Conclusions:
- The studies conducted provided no evidence to indicate absorption, distribution or clearance of the test substance and the most likely route of excretion was indicated likely to be via the gastro intestinal tract in the faeces.
- Executive summary:
The absorption, distribution, metabolism and excretion of FAT 36152/N have been predicted in the absence of toxicokinetic studies.
FAT 36152/N absorption was not indicated via the oral or dermal and ocular route of exposure.
FAT 36152/N no uptake via inhalation is expected.
FAT 36152/N is expected to have low dermal absorption.
FAT 36152/N and/or its predicted metabolites are unlikely to be widely distributed throughout the body.
Excretion of FAT 36152/N and any of its predicted metabolites is expected to be from the GI tract via the faeces.
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