Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
basic toxicokinetics, other
Remarks:
Toxicokinetic Assessment based on available studies
Type of information:
other: Toxicokinetic Assessment based on available studies
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Assessment based on available data
Justification for type of information:
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.
Objective of study:
other: Assessment of toxicokinetic behaviour
Principles of method if other than guideline:
Written assessment based on toxicological profile.
GLP compliance:
no
Species:
other: Not applicable
Details on exposure:
Not applicable
Duration and frequency of treatment / exposure:
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
Metabolites identified:
not measured
Details on metabolites:
Not applicable
Conclusions:
No bioaccumulation potential based on study results
Executive summary:

The results of basic toxicity testing give no reason to anticipate unusual characteristics with regard to the toxicokinetics of Reaktiv-Gelb F-68 072 FW . The data indicate that there is negligible toxicity from dermal absorption. Significant toxicity cannot be attributed to the material in prolonged exposure studies, and significant bioaccumulation of Reaktiv-Gelb F-68 072 FW can most probably be excluded due to the marked hydrophilic properties and lack of solubility in fat. Based on the negative mutagenicity assays, a metabolisation towards genotoxic sub-structures can be ruled out.

Description of key information

The results of basic toxicity testing give no reason to anticipate unusual characteristics with regard to the toxicokinetics of Reaktiv-Gelb F-68 072 FW . The data indicate that there is negligible dermal absorption. Significant toxicity cannot be attributed to the material in prolonged oral toxicity studies, and significant bioaccumulation of Reaktiv-Gelb F-68 072 FW can most probably be excluded due to the marked hydrophilic properties and lack of solubility in fat. Based on the negative genotoxocity assays, a metabolisation towards genotoxic sub-structures can be ruled out.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information