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PBT assessment

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PBT assessment: overall result

Reference
Name:
Reaction mass of benzenamine, 2-ethyl-N-(2-ethyl-nonylphenyl) nonyl-, branched and benzenamine, 2-ethyl-N-(2-ethyl-nonylphenyl)-, branched
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Reaction mass of benzenamine, 2-ethyl-N-(2-ethyl-nonylphenyl) nonyl-, branched and benzenamine, 2-ethyl-N-(2-ethyl-nonylphenyl)-, branched
Reference substance:
Reaction mass of benzenamine, 2-ethyl-N-(2-ethyl-nonylphenyl) nonyl-, branched and benzenamine, 2-ethyl-N-(2-ethyl-nonylphenyl)-, branched
PBT status:
the substance is not PBT / vPvB
Justification:

The substance is a substance of Unknown or Variable composition, Complex reaction products or Biological materials (UVCB) with multiple constituents. The physical state of the substance, reaction mass of benzenamine, 2-ethyl-n-(2-ethyl-nonylphenyl)nonyl-, branched and benzenamine, 2-ethyl-n-(2-ethyl-nonylphenyl)-, branched, is a dark amber liquid at room temperature and therefore, potential inhalation of the substance is negligible.

 

The two main constituents are benzenamine, 2-ethyl-n-(2-ethyl-nonylphenyl) nonyl-, branched and benzenamine, 2-ethyl-n-(2-ethyl-nonylphenyl)-, branched and their concentrations are typically 48% and 43%, respectively. The water solubility of the two main constituents are < 0.00076 mg/L and < 0.00027mg/L at 20 °C and pH 7, respectively. The partition coefficients (Log Kow) of the two main constituents are > 9.6 and > 9.1 at pH 7, respectively. The typical molecular masses of the two main constituents (C34H55N and C25H37N) are 477.82 and 351.56 Daltons, respectively. These data indicate that the substance has extremely low water solubility (< 0.1 mg/L) and is a highly lipophilic (Log Pow > 5.6) molecule, and thus the substance is not bioavailable via the oral route in accordance with Lipinski's rule of five. In addition, acute oral toxicity study in rats did not show any systemic effects up to 2000 mg/kg, the highest doses tested. Repeated dose oral toxicity studies in rats did not show any systemic effects up to 1000 mg/kg/day, the highest doses tested in both 14-day oral toxicity study and combined repeated dose oral toxicity study with the reproductive/developmental toxicity screening test. No information is currently available on possible degradation products produced in the gastrointestinal tract.

 

The extremely low water solubility and high lipophilicity of the substance also indicate that it is not expected to be absorbed via the dermal route. The local lymph node assay (LLNA) in mouse showed that the substance is not a skin sensitizer.

 

Additionally, the ready biodegradability test of the substance showed that it was 0% biodegradation after 28 days and was not considered readily biodegradable. The measured test concentrations of the substance in aquatic medium were very low, less than 0.344 mg/L in the acute toxicity tests in aquatic organisms (algae, daphnia, and fish). The substance is therefore expected to have low potential for bioaccumulation in aquatic organisms although the substance is persistent and its Log Pow exceeds 5.

 

In conclusion, based upon the available data, bioavailability of the substance, reaction mass of benzenamine, 2-ethyl-n-(2-ethyl-nonylphenyl)nonyl-, branched and benzenamine, 2-ethyl-n-(2-ethyl-nonylphenyl)-, branched,is expected to be very limited and the substance has low systemic toxicity.