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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
Leuco Sulphur Blue 13
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Conclusion on Persistance: vP (and P)

The ready biodegradability of the test substance was investigated according to the OECD 301 D. The test substance undergoes 9.9 % biodegradation after 28 days. Therefore, test substance is not regarded as readily biodegradable according to OECD criteria, but poorly biodegradable in this test. Based on the available data, the substance is considered to be vP (and P).

Conclusion on Bioaccumulation: Not B and not vB

The log Pow of the test item was measured according to an internal method to be < -0.3 (see IUCLID section 4.7). This result is below the threshold value for bioaccumulative potential of log Pow > 4.5 as cited in the ECHA Guidance on Information Requirements and Chemical Safety Assessment, Part C: PBT/vPvB assessment (Version 3.0, June 2017). Thus, the substance is considered to be neither very bioaccumulative (vB) nor bioaccumulative (B).

Conclusion on Toxicity: Not T

The 7 -d test with Lemna gibba revealed that the test substnce is not toxic at its solubility limit (LOEC > 0.305 mg/L, loading concentration: 25 mg/L).

The substance does not meet the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), toxic for reproduction (category 1A, 1B, or 2) or specific target organ toxicity after repeated exposure ((STOT RE category 1 or 2) according to Regulation EC No 1272/2008. Thus, the substance is considered as not T.

Overall conclusion on PBT and vPvB

Based on the available information, the substance is not PBT / vPvB according to Regulation (EC) 1907/2006.