Biphenyl-2-ylamine

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Experimental result from peer reviewed journal

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

The main objective of this study was to establish whether species differences play a significant role in the metabolism of 2-aminobiphenyl.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Biphenyl-2-ylamine

EC Number:

201-990-9

EC Name:

Biphenyl-2-ylamine

Cas Number:

90-41-5

Molecular formula:

C12H11N

IUPAC Name:

[1,1'-biphenyl]-2-amine

Constituent 2

Reference substance name:

biphenyl-2-ylamine (Synonym 2-aminobiphenyl)

IUPAC Name:

biphenyl-2-ylamine (Synonym 2-aminobiphenyl)

Test material form:

solid: crystalline

Details on test material:

CAS No: 90-41-5
Chemical Name: biphenyl-2-ylamine (Synonym 2-aminobiphenyl)
Nature of the chemical: Organic

Radiolabelling:

yes

Test animals

Species:

other: mice, rats, hamsters, guinea pigs

Strain:

other: albino mice, Wistar albino rats, Syrian golden hamsters, albino Dunkin-Hartley guinea pigs

Sex:

not specified

Details on test animals or test system and environmental conditions:

Mice, hamsters, guinea pigs and rats were kept in special metabolic cages and given standard diet and water.

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

corn oil

Details on exposure:

Mice, hamsters, guinea pigs and rats were kept in special metabolic cages and given standard diet and water. Each one was given a single intra-peritoneal dose (40 µCi/kg, 6.7mg/kg)of 2-ABP dissolved in com oil (0.5ml). Urine was collected continuously for 5 days. All urine samples were clarified bycentrifugation and frozen at -20oC until required for analysis. Aliquots of urine (20µl) were counted for radioactive content.

Duration and frequency of treatment / exposure:

5 days

Doses / concentrations

Remarks:

Doses / Concentrations:
6.7 mg/kg dissolved in 0.5 ml corn oil

No. of animals per sex per dose / concentration:

Details not available

Control animals:

not specified

Positive control reference chemical:

Details not available

Details on study design:

Details not available

Results and discussion

Main ADME results

Main ADME results 1

Type:

absorption

Results:

The chemical was absorbed after intra-peritoneal administration as a single dose

Main ADME results 2

Type:

distribution

Results:

Details not available

Main ADME results 3

Type:

metabolism

Results:

Results show that sulphate conjugation is a more effective route of metabolism than glucuronidation at the doses used and in all species used in these studies.

Main ADME results 4

Type:

excretion

Results:

Renal excretion accounts for about 30-40% of the administered dose during the first 24 hours.

Metabolite characterisation studies

Metabolites identified:

yes

Details on metabolites:

Unconjugated metabolites 2-ABP-50H, 2-ABP-30H, and conjugated 2-ABP-50S, 2-ABP-30S, and 2-ABP-50G.
Apart from these major peaks, minor conjugated metabolites were also detected: 2-ABP-NG in all species, 2-ABP-30G in all but hamster, 2-ABP-NS was found in hamster and small amounts in guinea pig urine.

Any other information on results incl. tables

Absorption: The chemical was absorbed afterintra-peritoneal administration as a single dose

Distribution:Details not available

Metabolism:Results show that the highest conversion of 2-ABP to different metabolites was with hamster and mice followed by guinea pig and rat. The major metabolite with all species was 2-ABP 50S. The isomeric 2-ABP-30S together with 2-ABP50G

were the next abundant metabolites. Results show that sulphate conjugation is a more effective route of metabolism than glucuronidation at the doses used and in all species used in these studies.

Excretion:Renal excretion accounts for about 30-40% of the administered dose during the first 24 hours. Results show that there was virtually no

species differences in the amount of total radioactivity eliminated in urine. After 5 days the radioactivity recovery was around 40-50% in all cases.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): low bioaccumulation potential based on study results
In an in vivo study, conducted on 4 rodent species using radio labelled [14C] 2-aminobiphenyl (2-ABP), using intra-peritoneal route of administration, the results of the metabolism and excretion indicate that after metabolism, 40 to 50 % chemical is excreted out of the living system via renal elimination. This suggests that the chemical biphenyl-2-ylamine (Synonym - 2-aminobiphenyl) shall have low bioaccumulation potential. The study also concludes that the chemical is relatively non-toxic given its failure to be converted to N-oxidation products

Executive summary:

In an in vivo study, conducted on 4 rodent species using radio labelled[¹⁴C] 2-aminobiphenyl (2-ABP), usingintra-peritoneal route of administration, the results of the metabolism and excretion indicate that after metabolism, 40 to 50 % chemical is excreted out of the living system via renal elimination. This suggests that the chemical biphenyl-2-ylamine (Synonym -2-aminobiphenyl) shall have low bioaccumulation potential. The study also concludes that the chemical is relatively non-toxic given its failure to beconverted to N-oxidation products