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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Reference
Name:
Reaction product of 4-​aminophenol​, aniline, 4-​methyl-​1,​3-​benzenediamine and p-​phenylenediamine with polysulfide
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Reaction product of 4-​aminophenol​, aniline, 4-​methyl-​1,​3-​benzenediamine and p-​phenylenediamine with polysulfide
Reference substance:
Reaction product of 4-​aminophenol​, aniline, 4-​methyl-​1,​3-​benzenediamine and p-​phenylenediamine with polysulfide
Reference substance:
Reaction product of 4-​aminophenol​, aniline, 4-​methyl-​1,​3-​benzenediamine and p-​phenylenediamine with polysulfide
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 23.4 % 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 is < -0.1 based on the solubility in water and n-octanol (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 EC10 or NOEC for marine/fresh water organisms (long term toxicity) is considered to be >= 0.01 mg/L based on a weight of evidence approach considering  the insolubility of the test item in aquatic test media (< 0.1 mg/L), its unlikelihood to cross biological membranes (due to its high molecular weight) and the NOEC  of >0.023 mg/L determined with the read across substance Leucosulphur Yellow 22 in a Lemna gibba (duckweed) study according to OECD 221.

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.