Registration Dossier

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:
2018
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
Name:
Unnamed
Type:
Constituent
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%)

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

Bioaccessibility 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.