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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998-11-24 to 1998-12-8

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:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

(1992)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(1987)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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: 9 weeks for the males, 11 weeks for the females
- Weight at study initiation: males: 234.3 - 258.8 g; females: 207.9-216.1 g
- Housing: individually in Makrolon type-3 cages with standard softwood bedding
- Diet: Pelleted standard Kliba 3433, batch no. 28/98, rat maintenance diet (Kliba Muehlen AG, CH-4303 Kaiseraugst) available ad libitum.
- Water: Community tap water from Itingen, available ad libitum
- Acclimation period: 6 days

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

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Details on dermal exposure:

TEST SITE
- % coverage: 10 % of the total body surface
- Type of wrap if used: semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw (4.0 mL/kg bw)

VEHICLE
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 as homogenizer. Homogeneity of the test article in the vehicle was maintained during treatment. The preparation was made shortly before dosing.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw (4.0 mL/kg bw)

No. of animals per sex per dose:

5 rats

Control animals:

not required

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 noted.

Clinical signs:

other: Slight scaling of the treated skin was observed in all animals. All males and four females showed focal erythema. In three males and in two females, serous rhinorrhea was noted. The treated skin was crusted in one animal only. All clinical and local signs

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 singe semi-occlusive application onto the skin
Sex	Number	Day 1	Day 8	Day 15
Females	5 animals	211.8 ± 3.5	216.5 ± 3.7	225.7 ± 11.3
Males	5 animals	244.8 ± 10.3	261.0 ± 15.0	289.0 ± 19.9

Applicant's summary and conclusion

Executive summary:

Five female or five male Wistar rats, were treated with FAT 80’220/A at 2000 mg/kg bw by single dermal application for 24 hours under semi-occlusive conditions. The test was conducted according to the OECD TG 402 (1987).The animals were examined for clinical signs four times during day 1 and once daily during days 2-15. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically.

No death occurred during the study.Slight scaling of the treated skin was observed in all animals. All males and four females showed focal erythema. In three males and in two females, serous rhinorrhoea was noted. The treated skin was crusted in one animal only. All clinical and local signs were reversible after 15 days. The body weight of the animals was within the range commonly recorded for animals of this strain and age. No macroscopic findings were observed at necropsy.

Thus, the acute dermal LD50 of the test item is > 2000 mg/kg bw.