Benzenamine, 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(oxy)]bis-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The method was described in OECD Guideline for Testing of Chemicals No. 401. The reported deviations were not considered to have affected either the validity or integrity of the study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

R&M1 rodent diet is used in place of LAD1; the temperature range on occasion during the study fell below the temperature range cited in the study protocol; the study protocol references Mitsui Toatsu Chemicals Inc., however, the company name has since ch

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

3-{[4'-(3-aminophenoxy)-[1,1'-biphenyl]-4-yl]oxy}aniline

EC Number:

700-102-1

Cas Number:

105112-76-3

Molecular formula:

C24H20N2O2

IUPAC Name:

3-{[4'-(3-aminophenoxy)-[1,1'-biphenyl]-4-yl]oxy}aniline

Details on test material:

- Name of test material (as cited in study report): 4,4'-bis(3-Aminophenoxy) biphenyl
- Substance type: Raw material of polymer
- Physical state: White powder
- Analytical purity: 99.98 %
- Lot/batch No.: 89-42001
- Expiration date of the lot/batch: October 2000
- Storage condition of test material: Room temperature
- Other: received on 21 October 1996, supplied by Mitsui Chemicals Inc.

Test animals

Species:

rat

Strain:

other: Hsd/Ola:Sprague-Dawley (CD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan U.K. Ltd., Bicester, Oxon, England
- Age at study initiation: four to seven weeks
- Weight at study initiation: 84 to 103 g
- Housing: five rats of the same sex in metal cages with wire mesh floors
- Diet (e.g. ad libitum): standard laboratory rodent diet (R&M1 SQC) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: five days prior to the start of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5 to 22
- Humidity (%): 37 to 59
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 1 % w/v aqueous methylcellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 % w/v
- Amount of vehicle (if gavage): 10 mL/kg bodyweight
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:


MAXIMUM DOSE VOLUME APPLIED:
2000 mg/kg bodyweight

Doses:

2000 mg/kg bodyweight

No. of animals per sex per dose:

5 females, 5 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing: Animals were observed soon after dosing and and at frequent intervals for the remainder of Day 1. On subsequent days animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). This latter observation was at approximately 16.30 hours on week days or 11.30 hours on Saturdays and Sundays. All animals were observed for 14 days after dosing. The bodyweight of each rat was recorded on Days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: yes. All animals were subjected to a macroscopic examination which consisted of opening the thoracic and abdominal cavities. The cranial cavity was not examined as observations did not indicate neurotoxic activity.
- Other examinations performed: clinical signs, body weight,organ weights

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 2 000 mg/kg bw

Mortality:

There were no deaths in a group of ten rats (five males and five females) following a single oral dose of 3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline at a dosage of 2000 mg/kg bodyweight.

Clinical signs:

other: Piloerection was observed in all rats within five minutes of dosing. There were no other signs of reaction to treatment and recovery, as judged by external appearance and behaviour, was complete in males by Day 5 and in females by Day 3.

Gross pathology:

No abnormalities were observed at the study termination necropsy.

Any other information on results incl. tables

Table 1: Individual bodyweights (g) of testing animals

Sex	Dose (mg/kg)	Animal Number	Bodyweight (g) at Day
			1	8	15
Male	2000	1	85	144	198
Male	2000	2	84	131	181
Male	2000	3	89	145	196
Male	2000	4	86	151	205
Male	2000	5	89	144	184
Female	2000	6	101	152	189
Female	2000	7	96	137	160
Female	2000	8	103	142	164
Female	2000	9	102	147	170
Female	2000	10	98	141	161

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute lethal oral dose to rats of 3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline was demonstrated to be greater than 2000 mg/kg bodyweight.

Executive summary:

The acute oral toxicity of 3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline to the rat was teted according to OECD Guideline for Testing of Chemicals No. 401 "Acute Oral Toxicity" Adopted: 24 February 1987.

A group of ten fasted CD Sprague Dawley rats (five males and five females) received a single oral dose of 3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline by gavage, formulated in 1% w/v aqueous methylcellulose, administered at a dose level of 2000 mg/kg body weight. All animals were killed and examined macroscopically on Day 15, the end of the observation period. Clinical signs of reaction to treatment were confined to piloerection (seen in all rats approximately 5 minutes after treatment). There were no other signs of reaction to treatment and recovery was complete in males by Day 5 and in females by Day 3. All animals achieved satisfactory body weight gain throughout the study. No abnormalities were observed at the study termination necropsy. The acute lethal oral dose to rats of 3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline and the oral LD50 value were demonstrated to be greater than 2000 mg/kg body weight.