Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

other: Assessment based upon available information.

Adequacy of study:

key study

Study period:

May 2013

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Information selected for the toxicokinetic assessment is primarily study data. Studies were conducted inaccordance with recognised testing guidelines. While some studieswere not conducted according to GLP due to the age of the study and geographical location, all studies were conducted in reputable contract research organisations using specifically bred models that are fully validated for the types of study. All data used for the toxicokinetic assessment is rated at least 2 for relevance and reliability (based upon Klimisch, 1997) and were conducted upon the registered substance, bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine.

Data source

Reference

Reference Type:

other: Desk study

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Objective of study:

toxicokinetics

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

All available informaiton on bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine has been reviewed and assessed to produce a report on the toxicokinetics properties of the substance.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine

EC Number:

239-816-9

EC Name:

Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine

Cas Number:

15721-78-5

Molecular formula:

C28H43N

IUPAC Name:

4-(2,4,4-trimethylpentan-2-yl)-N-[4-(2,4,4-trimethylpentan-2-yl)phenyl]aniline

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

SMILES : N(c(ccc(c1)C(CC(C)(C)C)(C)C)c1)c(ccc(c2)C(CC(C)(C)C)(C)C)c2
MOL FORMULA: C28 H43 N1
MOL WEIGHT : 393.66

Results and discussion

Any other information on results incl. tables

The particle size of bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine indicates that it is unlikely to be absorbed via the inhalation route (less than 10% 10µm), and based upon the above information bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is not expected to be absorbed via the oral route in accordance with Lipinski's rule of five. The low water solubility and high Log Pow of the substance indicate that bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is not easily absorbed in the body. No information is currently available on possible degradation products produced in the gastrointestinal tract. As bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is a solid powder with a very low water solubility (<0.1 mg/l), it is not expected to be absorbed via the dermal route.

During acute toxicity studies no systemic or local effects were noted at doses which humans are likely to come into contact.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): low bioaccumulation potential based on study results
Based upon the available data, bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is expected to have low potential for bioaccumulation.