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PBT assessment

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PBT assessment: overall result

Reference
Name:
N-isopropyl-N’-phenyl-p-phenylenediamine
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
N-isopropyl-N’-phenyl-p-phenylenediamine
PBT status:
the substance is not PBT / vPvB
Justification:

Persistence

IPPD is not readily biodegradable with 18.9 % biodegradation in 28 days (Flexsys 1979), and hence it is classified as preliminary persistent according to screening criteria.

Bioaccumulation

Due to the rapid hydrolysis of IPPD (half life 3.9 hours at 26°C) in aqueous media, a bioaccumulation potential is not expected.

Measured bioconcentration factors (BCF) for IPPD are not available. IPPD hydrolyses rapidly in the presence of water with a half life of approximately 3.9 hours. Therefore a risk estimation regarding the bioaccumulation potential of IPPD on the basis of a log Kow, determined by QSAR, is misleading. A calculated theoretical log Kow value of 3.28 reflects the unreacted molecule without influence of water.

The substance is not persistent in water due to the rapid hydrolysis. Therefore it is not bio-available. Possible hydrolysis products are less lipophilic. On the basis of these information it can not be expected that bioaccumulation of IPPD occurs. The main hydrolysis products are 4-Hydroxydiphenylamine, 4-(Phenylimino) cyclohexa-2,5-dien-1-one and Isoproyplamine. The first 2 compounds are regarded to be similar as they reflect different oxidised forms of the same compound.

Bioconcentration factors of 4-(Phenylimino) cyclohexa-2,5-dien-1-one and 1,3-Dimethylbutylamine (hydrolysis product of 6PPD) were determined according to OECD Guideline 305 C. The bioconcentration factor ranges from <1.2 - 23 using Cyprinus carpio as test organism. (MITI, 1995). Bioconcentration of Isopropylamine is expected to be even lower as 1,3-Dimethylbutylamine .Therefore the B and vB criterion is not fulfilled.

Toxicity

There are long-term aquatic toxicity tests available for algae and for fish. The most sensitive organisms were fish with a 30d-NOEC of 0.0037 mg/l (MITI 2003).Furthermore, the substance is not classified as carcinogenic, mutagenic or toxic for reproduction or R48. For these reasons, the substance does not meet the T-criterion.

Conclusion

A substance only is identified as a PBT substance if it fulfils all criteria described above According to information summarized above, the T criterion was fulfilled and the P criteria was preliminarily fulfilled. Hence IPPD is not PBT.

A substance only is identified as a vPvB substance if it fulfils both vPvB criteria described above. The P criterion is preliminarily fulfilled, the B criterion is not fulfilled. Therefore, IPPD is not vPvB.