p,p'-(2-pyridylmethylene)bisphenol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002-11-28 to 19-12-2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted under GLP conditions in accordance with the official OECD guideline 423 (2001).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

(December 2001)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

(September 1996)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

p,p'-(2-pyridylmethylene)bisphenol

EC Number:

210-039-7

EC Name:

p,p'-(2-pyridylmethylene)bisphenol

Cas Number:

603-41-8

Molecular formula:

C18H15NO2

IUPAC Name:

4-[(4-hydroxyphenyl)(pyridin-2-yl)methyl]phenol

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: RCC Ltd, Biotechnology and Animal Breeding Division; CH-4414 Füllinsdorf / Switzerland- Age at study initiation: Males: 9 weeks; Females: 12 weeks- Weight at study initiation: day 1 of treatment: female 193 to 202 g; male 239 g to 256 g - Fasting period before study: approximately 18 hours (access to water was permitted). Food was provided again 3 hours after dosing.- Housing: In groups of three per cage in Makrolon type-4 cages- Diet (e.g. ad libitum): ad libitum - Water (e.g. ad libitum): ad libitum- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.ENVIRONMENTAL CONDITIONS- Temperature (°C): 22+-3°C- Humidity (%): 30 to 70°C- Air changes (per hr): 10 to 15 - Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light (music during the light period)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

(PEG 300)

Details on oral exposure:

VEHICLE- Justification for choice of vehicle: The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date. This trial formulation is excluded from the GLP statement of compliance.- Lot/batch no. (if required): 435875/1 43002

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 male and 3 female rats

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days- Frequency of observations and weighing: Body weight: On test days 1 (prior to administration), 8 and 15; Mortality/Viability: daily during acclimatization and twice daily during days 1-15- Necropsy of survivors performed: yes- Other examinations performed: clinical signs (daily during acclimatization and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15)

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One male animal was found dead on test day 12.

Clinical signs:

other: Hunched posture and slight ruffled fur and was observed in all female animals on test day 2 and persisted up to 14 or 15, respectively. Emaciation was also noted from test day 8 to 14. Slight to moderate ruffled fur was noted in all male animals from 2-ho

Gross pathology:

No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dose of Oxypicoline RF after single oral administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat): greater than 2000 mg/kg body weight