3,3',5,5'-tetra-tert-butylbiphenyl-2,2'-diol

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: Guideline study (GLP)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

February 24, 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,3',5,5'-tetra-tert-butylbiphenyl-2,2'-diol

EC Number:

407-920-5

EC Name:

3,3',5,5'-tetra-tert-butylbiphenyl-2,2'-diol

Cas Number:

6390-69-8

Molecular formula:

C28 H42 O2

IUPAC Name:

3,3',5,5'-tetra-tert-butyl-[1,1'-biphenyl]-2,2'-diol

Details on test material:

- Name of test material (as cited in study report): generic name CA 16-178
- Physical state: solid, powder
- Analytical purity: 97.7% (not specified in the study [Lab. sample], transfered from 28d study [BASF SE [Ciba-Geigy Ltd/884619]], with same Lot/batch)
- Lot/batch No.: A 88103 / Z 1572R
- Storage condition of test material: room temperature
- Other: gloves and face masks as safety precautions

Test animals

Species:

rat

Strain:

other: albino rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: young adult albino rats (Tif; RAIf (SPF)) bred and raised on the premises from CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 174-203 g
- Fasting period before study: prior to dosing, the animals were fasted overnight
- Housing: 5 animals per cage in Macrolon cages type 4 (segregated by sex)
- Diet (e.g. ad libitum): rat chow (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland); ad libitum
- Water (e.g. ad libitum): drinking water; ad libitum
- Acclimation period: at least 5 days before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2°C
- Humidity (%): 55±10%
- Air changes (per hr): approx. 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Remarks:

Ol. arachidis Ph. H, VI

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml

MAXIMUM DOSE VOLUME APPLIED:
10 ml/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality daily (a.m. and p.m. on working days; a.m. on weekend days); signs and symptoms daily; body weight at start and on days 7 and 14
- Necropsy of survivors performed: yes; the animals were submitted to a gross necropsy at the end of the observation period.

Statistics:

From the body weights, the group means and their standard deviations were calculated.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred at this unique dose level; no specific signs of toxicity observed

Mortality:

No mortality occurred

Clinical signs:

other: Piloerection (up to day 6), hunched posture (up to day 4), and dyspnea (up to day 2) were seen, being common symptoms in acute tests. The animals recovered within 7 days.

Gross pathology:

At autopsy, no deviations from normal morphology were found.

Any other information on results incl. tables

Table 1: Mean body weight and standard deviation (g)

	At administration day	At day 7	At day 14
Males (2000 mg/kg bw)	194 ± 6.2	258 ± 13.9	305 ± 21.3
Females (2000 mg/kg bw)	185 ± 9.8	217 ± 8.8	233 ± 11.8