Sodium 2,4-diamino-5-(4-(2-sulfoxyethanesulfonyl)phenylazo)benzenesulfonate

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

calculation (if not (Q)SAR)

Remarks:

Migrated phrase: estimated by calculation

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

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.

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Materials and methods

Objective of study:

other: Assessment of toxicokinetic behaviour

Principles of method if other than guideline:

Written assessment based on toxicological profile.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

461-870-9

EC Name:

-

Cas Number:

795275-80-8

Molecular formula:

C14H14N4Na2O9S3

IUPAC Name:

Sodium 2,4-diamino-5-(4-(2-sulfoxyethanesulfonyl)phenylazo)b enzenesulfonate

Details on test material:

Not applicable

Test animals

Species:

other: 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

Metabolite characterisation studies

Metabolites identified:

not measured

Details on metabolites:

Not applicable

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): no bioaccumulation potential based on study results
No bioaccumulation potential based on study results and toxicological profile.

Executive summary:

The results are read across from the free acid form. Read across is applicable based on the content of sodium ions. The presence of these is determined by the pH of the isolation of the dyestuff itself. Therefore the substance to be registered is deemed to be a mixture of free acid, mono and di sodium salts. Upon comparison of the NMR-Spectra of the substance to be registered and the read across chemical it is evident that the chemical shifts as well as the integrations are the same, hence it is difficult to quantify free acid, mono and di variants. The CAS number proposed for the substance to be registered covers the sodium element. The associated free acid has a unique CAS number; this is referenced in the substance identity, as does the disodium variant, which is also referenced.

The results of basic toxicity testing give no reason to anticipate unusual characteristics with regard to the toxicokinetics of Reaktiv-Gelb 201 . 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 201 can most probably be excluded due to the marked hydrophilic properties . Based on the negative mutagenicity assays, a metabolisation towards genotoxic sub-structures can be ruled out.