Disodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Acid Brown 282 (ABr282) undergoes a primary degradation in the first days of the test, when it reaches a percentage of degradation (about 24-32%) that remains similar for the following days, up to the 28th day. It is clear that ABr282 is not ready biodegradable, nevertheless the test results do not provide sufficient information to clearly confirm the substance to be persistent. The QSAR based screening criterion for identifying substances for persistency (P and vP) confirmed however that the substance is expected to be persistent.

 

There are no empirical bioaccumulation data available for ABr282, nevertheless the Pow determined by means of shake flask method as per recommendations of OECD 107, resulted 0.8654 (log Pow: -0.0752) at 20 °C, showing a low affinity with the organic fraction. Therefore bioaccumulation is not considered relevant for ABr282 and it does not fulfil the B-criterion.

 

Chronic ecotoxicological data are not available for ABr282, 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 cannot 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, ABr282 does not meet all the three criteria to be considered as a PBT substance.