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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Environmental fate & pathways

Bioaccumulation: aquatic / sediment

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
bioaccumulation in aquatic species: fish
Type of information:
(Q)SAR
Adequacy of study:
supporting study
Study period:
September 2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Qualifier:
no guideline followed
Principles of method if other than guideline:
QSAR prediction (BCFBAF v3.01)
Test organisms (species):
other: fish
Key result
Type:
BCF
Value:
3.162 L/kg
Basis:
whole body w.w.
Remarks on result:
not measured/tested

3.5        The chemical and biological mechanisms according to the model underpinning the predicted result (OECD principle 5). 

- Molecular weight:        482.57 g/mol (< 500 daltons = good absorption)
- Water solubility:            46 +/- 3 g/L (= soluble in water)
- Partition coefficient:     log Kow = -1.6 (> -0.4 or < 5.6 = good absorption)

Based on physico-chemical data and the results of human toxicity studies, Basic Blue 41 Methyl sulfate has a good oral, however only limited dermal and inhalation bioavailability. Also, there is wide tissue distribution of Basic Blue 41 after oral exposure, but bioaccumulation is unlikely. According to its low log Kow, Basic Blue 41 methyl sulphate does not show any potential for bioaccumulation.

 

4. Adequacy (Optional)

The information is used in a weight-of-evidence approach for the assessment of the bioaccumulation potential of the substance, as part of the PBT assessment. This approach is considered adequate as experimental testing of the bioaccumulation potential in fish is not foreseen in REACH Annex VIII.

4.1        Regulatory purpose: Use in a weight-of evidence approach in the PBT assessment of the substance.

4.2        Approach for regulatory interpretation of the model result: According to REACH Annex XIII, a substance is considered bioaccumulative (B) or very bioaccumulative (vB) in case the BCF of the substance is > 2000 or > 5000, respectively.

4.3        Outcome: As the estimated BCF is 3.162 L/kg wet weight and thus << 2000, the substance is not considered to bioaccumulate.

4.4        Conclusion: The result is considered adequate for a regulatory conclusion.

Validity criteria fulfilled:
not applicable
Conclusions:
The test substance is considered to have a very low potential for bioaccumulation.
Executive summary:

The bioaccumulation potential of Basic Blue 41 methyl sulfate was estimated by means of BCFBAF program (v3.01) which is part of EPISuite v4.1 (US EPA). The estimation is based on the chemical structure of the substance as well as on the log Kow.

The estimation results in a BCF of 3.162 L/kg wet weight. Thus, the substance is considered to have a very low potential for bioaccumulation.

Description of key information

The bioaccumulation prediction by means of the BCFBAF program (v3.01) results in a BCF of 3.162 L/kg wet weight.

Key value for chemical safety assessment

BCF (aquatic species):
3.162 L/kg ww

Additional information