Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 416-840-1 | CAS number: 201426-52-0
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: Various
- Adequacy of study:
- key study
- Study period:
- Various
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Studies undertaken in GLP accredited laboratories to internationally recognised guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2013
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline available
- Guideline:
- other: Various
- GLP compliance:
- yes
Test material
- Reference substance name:
- LumiNova G
- IUPAC Name:
- LumiNova G
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): LumiNova
- Substance type: Pigment
- Physical state: Powder
- Lot/batch No.: Various
- Stability under test conditions: Stable
- Storage condition of test material: Rooom temperature in the dark.
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: Rat and rabbit
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
The test animals were obtained from a commercial laboratory animal supplier.
ENVIRONMENTAL CONDITIONS
The environmental conditions for the animals were according to and better than those recommended in the guidelines.
Administration / exposure
- Route of administration:
- other: Oral and dermal
- Vehicle:
- unchanged (no vehicle)
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The results of the toxicity studies conducted on LumiNova G showed no evidence of systemic toxicity that would indicate adsorption.
- Details on distribution in tissues:
- There was no conclusive evidence that LumiNova was distributed in tissues.
- Details on excretion:
- There was no evidence of excretion.
Metabolite characterisation studies
- Metabolites identified:
- no
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- None undertaken
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
At this tonnage band, Annex viii, none of the toxicity studies undertaken give undisputed proof that LumiNova G is toxic. Chronic studies at higher tonnage bands may prove to be more forthcoming.
At this point LumiNova G requires further testing for a toxicokinetic assessment to be conclusive.
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.
