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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Acid Brown 355 (ABr355) was tested for the ready biodegradability in a study conducted according to the OECD Guideline 301 A. Under the test conditions, no biodegradation was observed (0 % after 28 days, based on the DOC-removal). The substance is not ready biodegradable, nevertheless there are no information about the inherently biodegradation potential. Thus, the potential for persistence (P or vP) can not be judged.

There are no empirical bioaccumulation data available for ABr355, nevertheless the Pow was calculated as 0.04681 (average log Pow: -1.359), thus it is expected that ABr355 has a low potential for bioaccumulation and/or a low potential to cross biological membranes. According to the screening criteria, ABr355 is not B and not vB based on Log Kow ≤ 4.5; therefore B-criterion is not fulfilled.

Chronic ecotoxicological data are not available for ABr355, nevertheless short-term toxicity studies show that the substance can cause adverse effects on aquatic organisms. The substance is not classified as carcinogenic, germ cell mutagenic or toxic for reproduction and there are no other evidence of chronic toxicity, based on the repeated dose toxicity study.

A conclusion about the T-criterion can not be reached.

According to the REACH Regulation (EC 1907/2006), Annex XIII, a substance that fulfils the persistence, bioaccumulation and toxicity criteria shall be considered to be a PBT substance. Taken into account the available data, ABr355 does not meet all the three criteria to be considered as a PBT substance.