Disodium 7-[[4,6-bis[(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate

PBT assessment

PBT assessment: overall result

Reference

Reference 1

Name:

Direct Red 253

Type of composition:

legal entity composition of the substance

State / form:

solid: particulate/powder

Reference substance:

Direct Red 253

Reference 2

Name:

Direct Red 253

Type of composition:

boundary composition of the substance

State / form:

solid: particulate/powder

Reference substance:

Direct Red 253

PBT status:

the substance is not PBT / vPvB

Justification:

PERSISTENCE

Because of the chemical structure and functional groups presents, hydrolysis can be considered as negligible degradation pathway and the substance is not expected to be ready biodegradable. The biodegradability potential estimated based on QSAR/QSPR prediction confirmed this expectation. However, the available information do not permit to reach a conclusion about the inherently biodegradation potential, thus it is not known if the substance has a potential for persistence (P or vP). A conclusion about the P-criterion cannot be reached.

BIOACCUMULATION

There are no empirical bioaccumulation data available for Direct Red 253, however the log Kow was experimentally determined to be -1.98 ± 0.11 at 23 °C and pH 6.5 (Havránková, 2016). Thus, due to the physicochemical properties, the substance is expected to possess a low potential to cross biological membranes.

TOXICITY

Aquatic long-term toxicity data are not available for Direct Red 253, nevertheless short-term toxicity studies show that the substance does not cause adverse effects on aquatic organisms and it does not meet the criteria to be classified hazardous for aquatic life. The substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008 and there are no other evidence of chronic toxicity, as identified by the classifications specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008.

Although the substance is expected to not meet the criteria to be considered T, a conclusion about the T-criterion cannot be reached in agreement with the REACH Regulation (EC 1907/2006).

CONCLUSION

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, Direct Red 253 does not meet all the three criteria to be considered as a PBT substance.