Registration Dossier
Registration Dossier
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EC number: 279-317-3 | CAS number: 79828-43-6
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: Expert statement
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Expert Statement
- Qualifier:
- according to guideline
- Guideline:
- other: OECD QSAR Application Toolbox (v 3.0)
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Conclusions:
- Reactive black 8 was found to be a strong skin sensitizer. There are clear indications from available toxicity studies that Reactive Black 8 and its metabolites predicted with the OECD toolbox do not present a genotoxic hazard or other adverse effects in animals.
- Executive summary:
The toxicokinetic behaviour of Reactive Black 8 was assessed. The OECD QSAR Application Toolbox (v 3.0) was used to make a qualitative prediction of metabolites formed in liver and skin. The information provided by the OECD toolbox was interpreted by applying knowledge from actual toxicological studies on the substance and expert knowledge on the moieties of the substance.
Reactive Black 8 was predicted to be bioavailable by the oral and inhalation route, whereas bioavailability via the dermal route is predicted to be low.
Tissue accumulation can be excluded on the basis of the physico-chemical properties of Reactive Black 8 and that of the predicted metabolites.
No metabolites in the simulated liver metabolism were found. Only one metabolite, the hydrochloric acid, was predicted in the skin by the OECD toolbox (v 3.0). Rapid elimination of the metabolites via urine is expected.
Reactive black 8 was found to be a strong skin sensitizer. There are clear indications from available toxicity studies that Reactive Black 8 and its metabolites predicted with the OECD toolbox do not present a genotoxic hazard or other adverse effects in animals.
Reference
The toxicokinetic behaviour of Reactive Black 8 was assessed. The OECD QSAR Application Toolbox (v 3.0) was used to make a qualitative prediction of metabolites formed in liver and skin. The information provided by the OECD toolbox was interpreted by applying knowledge from actual toxicological studies on the substance and expert knowledge on the moieties of the substance.
Reactive Black 8 was predicted to be bioavailable by the oral and inhalation route, whereas bioavailability via the dermal route is predicted to be low.
Tissue accumulation can be excluded on the basis of the physico-chemical properties of Reactive Black 8 and that of the predicted metabolites.
No metabolites in the simulated liver metabolism were found. Only one metabolite, the hydrochloric acid, was predicted in the skin by the OECD toolbox (v 3.0). Rapid elimination of the metabolites via urine is expected.
Reactive black 8 was found to be a strong skin sensitizer. There are clear indications from available toxicity studies that Reactive Black 8 and its metabolites predicted with the OECD toolbox do not present a genotoxic hazard or other adverse effects in animals.
Description of key information
The toxicokinetic behaviour of Reactive Black 8 was assessed. The OECD QSAR Application Toolbox (v 3.0) was used to make a qualitative prediction of metabolites formed in liver and skin. The information provided by the OECD toolbox was interpreted by applying knowledge from actual toxicological studies on the substance and expert knowledge on the moieties of the substance.
Reactive Black 8 was predicted to be bioavailable by the oral and inhalation route, whereas bioavailability via the dermal route is predicted to be low.
Tissue accumulation can be excluded based on the physico-chemical properties of Reactive Black 8 and that of the predicted metabolites.
No metabolites in the simulated liver metabolism were found. Only one metabolite, the hydrochloric acid, was predicted in the skin by the OECD toolbox (v 3.0). Rapid elimination of the metabolites via urine is expected.
Reactive black 8 was found to be a strong skin sensitizer. There are clear indications from available toxicity studies that Reactive Black 8 and its metabolites predicted with the OECD toolbox do not present a genotoxic hazard or other adverse effects in animals.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
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