2-Propanone, reaction products with diphenylamine

PBT assessment

PBT assessment: overall result

Reference

Reference 1

Name:

2-Propanone, reaction products with diphenylamine - DPA content < 10%

Type of composition:

boundary composition of the substance

State / form:

solid: particulate/powder

Reference substance:

2-Propanone, reaction products with diphenylamine - DPA content < 10%

Reference 2

Name:

2-Propanone, reaction products with diphenylamine - DPA content >=10%; <25%

Type of composition:

boundary composition of the substance

State / form:

solid: particulate/powder

Reference substance:

2-Propanone, reaction products with diphenylamine - DPA content >=10%; <25%

PBT status:

the substance is not PBT / vPvB

Justification:

PBT Assessment for Aminox®

Persistence

A key study is available on the ready biodegradability of the substance which was conducted in accordance with OECD test guideline 301F. The results of the study showed that the overall degradation after 28 days was 0% based on ThODNH4and ThODNO3,and thus it was concluded that the substance is not readily biodegradable.

 

Bioaccumulation

A key study evaluating the substances octanol-water partition coefficient in accordance with OECD 117 concluding that the substance has a log kow ranging from 3.17 to > 6.5 based on the calculations and reference substance data. Resulting in the substance screening as potentially Bioacumulative/very Bioaccumulative (> 6.5) to being not potentially Bioacumulative/very Bioaccumulative (≤ 4.5). However the substance is a UVCB. has a high molecular weight (1830) and has a variable particion coefficient, therefore a linear relationship between the partition coefficient and bioaccumulation cannot be concluded on the analysis of the physicochemical properties alone.

An acute toxicity study and combined 28 day repeated dose with reproductive/developmental screening study using rats, conducted according to EPA and EU method B.7 test guidelines concluded that there was distinct lack of toxicologically relevant effects associated with the test substance when administered orally. Therefore insinuating that the bioavailability should be considered to be low via the oral route for animals. The absorption of highly lipophilic substances with a log Kow > 4, may be hindered by the inability to dissolve in gastrointestinal fluids and therefore come into contact with the mucosal surface. Although absorption may be increased if the substance were to undergo micellular solubilisation by bile salts.

Based on the available information, the substance cannot be adequately defined as bioaccumulative.

 

Toxicity

A number of valid key studies are available which determined the substance to be not systemically toxic, mutagenic, or toxic to aquatic organisms and nor do they provide evidence of effects relating to carcinogenicity, mutagenicity, reproductive/developmental toxicity.

 

 

Conclusions

In conclusion the substance is not considered to be a PBT vPvB substance.

The substance has been determined to be not readily biodegradable in a OECD 301F study, with only 28% degradation occurring within 28 days. Indicating that the substance would be persistent within the environment.

The screening criteria for Bioaccumulative/Very bioaccumulative is met, however given its octanol-water partition coefficient, the lack of effects from oral toxicity studies is implicit of low bioaccumulation potential, thus no definitive conclusion could be made on the available information.

The substance did not fulfil the Toxicity criterion.

Therefore, base on the available data, the substance cannot be considered as a PBT or vPvB substance according to the criterion in Annex XIII of the REACH regulation.