Registration Dossier
Registration Dossier
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EC number: 229-633-2 | CAS number: 6635-20-7
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: Weight of evidence
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The physico-chemical parameters as well as the bio-concentration factors can provide reliable indiactions on the toxico-kinetic behavior of a chemical & whether the chemical shall have a tendency to bio-accumulate.
Data source
Reference
- Reference Type:
- other: Weight of evidence
- Title:
- Toxicokinetics
- Author:
- Sustainability Support Services (Europe) AB
- Year:
- 2 012
- Bibliographic source:
- Based on the weight of evidence of various phys chem and bioaccumulative parameters in the dossier
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Based on the weight of evidence of various phys chem and bioaccumulative parameters in the dossier
- GLP compliance:
- no
Test material
- Reference substance name:
- 5-nitrovanillin
- EC Number:
- 229-633-2
- EC Name:
- 5-nitrovanillin
- Cas Number:
- 6635-20-7
- Molecular formula:
- C8H7NO5
- IUPAC Name:
- 4-hydroxy-3-methoxy-5-nitrobenzaldehyde
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Not applicable
Constituent 1
Test animals
- Species:
- other: unspecified
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Not applicable
Administration / exposure
- Route of administration:
- other: Not applicable
- Vehicle:
- other: Not applicable
- 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
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The most likely route of absorption considering the use of 5-nitrovanillin in dyeing is expected to be through the dermal route followed by the inhalation route. However, prediction values for dermal absorption do not indicate a high potential for dermal absorption (0.00600 mg/cm2/event)
Potential of absorption of this chemical by the inhalation route is also unlikely given that the particle size of the chemical is not in the inhalable size and the vapour pressure is also low (0.000794Pa) - Details on distribution in tissues:
- Given the poor water solubility of 5-nitrovanillin in water, it is expected that even if the chemical if absorbed within the living system, it is unlikely to be distributed to various parts of the living system through the blood. It may though be transerred to the other body parts via the plasma as it is more soluble in organic solvent.
- Details on excretion:
- 5-Nitrovanillin has very low bio-concentration factor (BCF ranging between 3.88 to 4.2). This is much less than the threshold value of 2000 to suggest bio-accumulation. Thus, the chemical is unlikely to bio-accumulate within the living system and shall be excreted out of the living system quickly either through the urine, excreta or bile
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- Not applicable
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: No bioaccumulation potential based on WoE of various physico-chemical parameters and BCF value
The substance, 5 -nitrovanillin does not have a bioaccumulation potential based on weight of evidence of physicochemical parameters and low bio-concentration factor of the chemical. - Executive summary:
The substance, 5 -nitrovanillin does not have a bioaccumulation potential based on weight of evidence of physicochemical parameters and low bio-concentration factor of the chemical.
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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