Registration Dossier
Registration Dossier
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EC number: 260-913-7 | CAS number: 57712-94-4
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:
- 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-N-tridecylnaphthalen-2-amine
- EC Number:
- 260-913-7
- EC Name:
- 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-N-tridecylnaphthalen-2-amine
- Cas Number:
- 57712-94-4
- Molecular formula:
- C37H47N5
- IUPAC Name:
- 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-N-tridecylnaphthalen-2-amine
- Test material form:
- liquid: viscous
- Details on test material:
- Substance name: Solvent Red 19T
Other name: 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-Ntridecylnaphthalen-2-amine
CAS number: 57712-94-4
EC Number: 260-913-7
Batch/Lot Number: TE 2139
Description: Dark red viscous liquid
Purity: 95-100%
Expiry date: 07 July 2018
Storage conditions: Room temperature (15-25°C, ≤70 RH%)
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 via understood paths for azo dyes such as azo reduction. Such metabolites are subsequently eliminated within 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 via understood paths for azo dyes such as azo reduction. Such metabolites are subsequently eliminated within urine. Consequently, the substance is considered to have low bioaccumulation potential.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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