Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: evaluation based on present data
- Adequacy of study:
- key study
- Reliability:
- other: A written assessment based on the 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
Materials and methods
- Objective of study:
- other: Assessment of toxicokinetic behaviour
- Principles of method if other than guideline:
- A written assessment based on the toxicological profile of the substance.
- GLP compliance:
- no
Test material
- Details on test material:
- Not applicable
Constituent 1
Test animals
- Species:
- other: Not applicable
- Details on test animals or test system and environmental conditions:
- 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
- Preliminary studies:
- Not applicable
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Not applicable
- Details on distribution in tissues:
- Not applicable
- Details on excretion:
- Not applicable
Metabolite characterisation studies
- Details on metabolites:
- Not applicable
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: no bioaccumulation potential based on review of study results
- Executive summary:
The results of basic toxicity testing give no reason to anticipate unusual characteristics with regard to the toxicokinetics of Reactive Yellow F01-0555. The data indicate that there is little or no dermal absorption. Significant bioaccumulation of Reactive Yellow F01-0555 can most probably be excluded due to the marked hydrophilic properties. On the negative mutagenicity assays, a metabolism towards genotoxic sub-structures can be ruled out
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
