5-chloro-2-(4-chlorophenoxy)phenol;[DCPP]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998-11-18 to 1998-11-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study, GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

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:

(1996)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(1996)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

429-290-0

EC Name:

-

Cas Number:

3380-30-1

Molecular formula:

C12 H8 Cl2 O2

IUPAC Name:

5-chloro-2-(4-chlorophenoxy)phenol

Details on test material:

- Name of test material (as cited in study report): FAT 80'220/A
- Physical state: solid, powder
- Analytical purity: >99 %
- Lot/batch No.: GRU 98
- Expiration date of the lot/batch: 2008-10-31
- Stability under test conditions: 10 days in 1 % polyethylene glycol at room temperature (approx. 20°C).
- Storage condition of test material: in the original container at room temperature (approx. 20°C) away from direct sunlight; the test item was stable under storage conditions.

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 & Animal Breeding Division CH-4414 Fuellinsdorf/Switzerland
- Age at study initiation: Females 10 weeks; Males 8 weeks
- Weight at study initiation: Females, 179.4-188.8 g; Males, 200.7-211.2 g
- Housing: In groups of 3 rats/sex in Makrolon type- 4 cages
- Diet: Pelleted standard Kliba 3433, batch no. 28/98, rat maintenance diet (Kliba Mühlen AG, CH-4303 Kaiseraugst) available ad libitum
- Water: Community tap water from Itingen, available ad libitum
- Acclimation period: 7 days

- ENVIRONMENTAL CONDITIONS:
- Temperature: 22 +/- 3°C
- Humidity: 40 - 70 %
- Air changes: 10-15 air changes/ hour
- Photoperiod: 12 hours dark/ 12 hours light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL, based on dose volume
- Amount of vehicle (if gavage): 10 mL/Kg bw
- Justification for choice of vehicle: standard vehicle for studies of this type

DOSAGE PREPARATION
The test article was placed into a glass beaker on a tared Mettler PG 503-S balance and the vehicle (polyethylene glycol) was added. A weight by volume dilution was prepared using a magnetic stirrer as homogenizer. Homogeneity of the test article in the vehicle was maintained during treatment. The preparation was made shortly before each dosing.

Doses:

2000 mg/Kg bw

No. of animals per sex per dose:

3 rats

Control animals:

no

Details on study design:

OBSERVATION PERIOD
14 days
MORTALITY AND CLINICAL SYMPTOMS
Mortality was recorded together with clinical signs four times during test day 1 and once daily from day 2 to 15.
BODY WEIGHT
Body weights were recorded on day 1 prior to administration and on days 8 and 15.
NECROPSY
At test ending the survivors were sacrificed for the purpose of necropsy by intraperitoneal injection of NARCOREN (Rhone Merieux GmbH,
D-88471 Laupheim) at a dose of at least 2.0 mL/Kg bw (equivalent to at least 320 mg sodium pentobarbitone/Kg bw). The animals were then subjected to gross pathological examination.

Statistics:

No statistical analysis was used as no deaths occurred.

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.

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical signs were observed during the study period in all females, and in two of three males. One male suffered from diarrhea five hours after treatment only.

Gross pathology:

No macroscopic findings were observed at necropsy.

Any other information on results incl. tables

Group mean body weights (g) with standard deviation for male and female rats treated with 2000 mg/kg bw of test item by single oral gavage
Sex	Number	Day 1	Day 8	Day 15
Females	3 animals	182.6 ± 5.4	209.4 ± 3.9	223.4 ± 4.9
Males	3 animals	205.4 ± 5.3	255.0 ± 7.6	286.1 ± 5.2