Registration Dossier
Registration Dossier
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EC number: 235-517-2 | CAS number: 12262-25-8 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 53430.
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Leuco Sulphur Blue 9
- Type of composition:
- legal entity composition of the substance
- State / form:
- solid: particulate/powder
- Reference substance:
- Leuco Sulphur Blue 9
- Reference substance:
- Leuco Sulphur Blue 9
- Reference substance:
- Leuco Sulphur Blue 9
- 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 degredation of the test substance was 9.3 % after 28 days. Therefore, the 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 is estimated to be < -0.1 (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 not considered to be very bioaccumulative (vB) or bioaccumulative (B).
Conclusion on Toxicity: Not T
In a Growth Inhibition Test with Lemna gibba the test item had no toxic effect at aquatic saturation (i.e. limit test concentration). The overall LOEC from growth rate and yield is higher than the nominal concentration of 100 mg/L (solubility level) of the test item in the test medium, which corresponds to the mean measured concentration of 0.4 mg/L, based on water accommodated fraction of total product.
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.
Reference
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