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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

Constituent 1
Chemical structure
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 resultsopen allclose all
Type:
absorption
Results:
The chemical was absorbed after intra-peritoneal administration as a single dose
Type:
distribution
Results:
Details not available
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.
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

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