Registration Dossier
Registration Dossier
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EC number: 290-505-4 | CAS number: 90170-70-0
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- Written assessment
- Type of information:
- other: Written assessment
- Adequacy of study:
- other information
- Study period:
- March 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Written assessment
- Justification for type of information:
- At the current level of registration, a written assessment is suitable.
Data source
Reference
- Reference Type:
- other: Written assessment
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
- Objective of study:
- other: Written assessment of ADME
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Written assessment based on available study data.
Test material
- Reference substance name:
- 9,10-Anthracenedione, 1,4-diamino-, N,N'-mixed 2-ethylhexyl and 3-[(2-ethylhexyl)oxy]propyl and 3-methoxypropyl derivs.
- EC Number:
- 290-505-4
- EC Name:
- 9,10-Anthracenedione, 1,4-diamino-, N,N'-mixed 2-ethylhexyl and 3-[(2-ethylhexyl)oxy]propyl and 3-methoxypropyl derivs.
- Cas Number:
- 90170-70-0
- Molecular formula:
- Not available
- IUPAC Name:
- 1,4-bis({3-[(2-ethylhexyl)oxy]propyl}amino)-9,10-dihydroanthracene-9,10-dione; 1,4-bis[(2-ethylhexyl)amino]-9,10-dihydroanthracene-9,10-dione; 1-[(2-ethylhexyl)amino]-4-({3-[(2-ethylhexyl)oxy]propyl}amino)-9,10-dihydroanthracene-9,10-dione
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Solvent Blue 79B
- Physical state: Semi Solid/highly viscous liquid
- Lot/batch No.:TE2141
- Internal sample ref: S3493 and S3378
Constituent 1
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- See attached background material below.
- Details on distribution in tissues:
- See attached background material below.
- Details on excretion:
- See attached background material below.
Metabolite characterisation studies
- Details on metabolites:
- See attached background material below.
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- See attached background material below.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, there is evidence that the substance is absorbed on ingestion and metabolised. The substance and / or its metabolites then show an affinity to adipose tissue before subsequent excretion. Toxicity following absorption is likely to be limited, with elimination being undertaken via dissolution in bile, faeces and urine. Consequently, the substance is considered to have low bioaccumulation potential.
- Executive summary:
In conclusion, there is evidence that the substance is absorbed on ingestion and metabolised. The substance and / or its metabolites then show an affinity to adipose tissue before subsequent excretion. Toxicity following absorption is likely to be limited, with elimination being undertaken via dissolution in bile, faeces and urine. Consequently, the substance is considered to have low bioaccumulation potential.
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