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Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from authoritative source

Data source

Reference
Reference Type:
secondary source
Title:
NTP TECHNICAL REPORT ON THE CARCINOGENESIS BIOASSAY OF 2-BIPHENYLAMINE HYDROCHLORIDE (CAS NO. 2185-92-4) IN F344/N RATS AND B6C3F1 MICE (FEED STUDY)
Author:
NATIONAL TOXICOLOGY PROGRAM
Year:
1982
Bibliographic source:
NATIONAL TOXICOLOGY PROGRAM Technical Report Series No. 233, NTP-81-35 NIH Publication No. 83-1789

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as below
Principles of method if other than guideline:
Acute oral toxicity study was carried out to assess the effects of 2 biphenylamine on mice.
GLP compliance:
not specified
Test type:
other: no data available
Limit test:
no

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:
2 Biphenylamine
IUPAC Name:
2 Biphenylamine
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): 2-Biphenylamine
- Molecular formula (if other than submission substance): C12-H11-N
- Molecular weight (if other than submission substance): 169.226
- Substance type: Organic
- Physical state: Solid (colorless or purplish crystals)
- Impurities (identity and concentrations):. 0.006-0.049% 4-biphenylamine

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Frederick Cancer Research Center (Frederick, MD)
- Age at study initiation: 6-7 weeks old
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: 2 per cage
- Diet (e.g. ad libitum): Wayne Lab Blox® meal, Allied M ills, Inc. (Chicago, IL). Available ad libitum
- Water (e.g. ad libitum): Available ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.2°-32.2°C.
- Humidity (%): uncontrolled.
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): Fluorescent lighting provided 12 hours per day.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
- Concentration in vehicle: 1, 10, 100, 1000 and 10,000 mg/Kg bw
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle: No data available
- Lot/batch no. (if required): No data available
- Purity: No data available

MAXIMUM DOSE VOLUME APPLIED: No data available

DOSAGE PREPARATION (if unusual): Single preparation

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data available
Doses:
1, 10, 100, 1000 and 10,000 mg/Kg bw
No. of animals per sex per dose:
2/sex/dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed daily for mortality and signs of toxicity; weighed on day 1,7, and 14
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight, Gross pathology
Statistics:
No data available

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD100
Effect level:
10 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
1 000 mg/kg bw
Based on:
test mat.
Mortality:
Both animals died at the 10000 mg/kg bw dose level
Clinical signs:
Animals receiving 10000 mg/ kg showed hyperactivity, prostration, and shallow breathing
Body weight:
There was a slight change in body weight of animals at the end of the 14-day observation period.
Gross pathology:
Necropsy showed dark intestinal contents, enlarged lymph nodes, and reddened nasal conchae. Macroscopic examination of animals in the remaining dose groups revealed the presence of enlarged Peyer's patches.
Other findings:
In addition, mice receiving 10mg/kg or 100mg/kg doses had slight opacity in the lens region of the eye

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) for the test compound 2 biphenylamine in male mice is found to be 1000 mg/kg whereas the LD100 for male and female mice is found to be 10000 mg/kg bw.
Executive summary:

Single dose studies were carried out to test the effects of 2 biphenylamine on male and female mice. The dose concentrations used were 1, 10, 100, 1000 and 10,000 mg/Kg bw.

 

Male and female mice given a single dose of 10 g/kg technical-grade 2-biphenylamine died within 24 hours following administration. Prior to death, these animals showed hyperactivity, prostration, and shallow breathing. Necropsy showed dark intestinal contents, enlarged lymph nodes, and reddened nasal conchae. Macroscopic examination of animals in the remaining dose groups revealed the presence of enlarged Peyer's patches.

In addition, mice receiving 10mg/kg or 100 mg/ kg doses had slight opacity in the lens region of the eye. Mice receiving the 1 g/kg-1000mg/kg dose had mesenteric lymph node enlargement. One mouse in this group died because of a gavage accident. There was a slight change in body weight of animals at the end of the 14-day observation period.

 

Based on the results observed, The acute oral median lethal dose (LD50) for the test compound 2 biphenylamine in male mice is found to be 1000 mg/kg whereas the LD100 for male and female mice is found to be 10000 mg/kg bw.

 

According to the CLP & Harmonized Classification, the test material classifies as an acute toxicant Category 4 chemical.

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