5-chloro-2-(2,4-dichlorophenoxy)aniline

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24.02.1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: E.C. Directive No. 92/69/E.E.C., B3, 31.07.1992

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-chloro-2-(2,4-dichlorophenoxy)aniline

EC Number:

260-480-4

EC Name:

5-chloro-2-(2,4-dichlorophenoxy)aniline

Cas Number:

56966-52-0

Molecular formula:

C12H8Cl3NO

IUPAC Name:

5-chloro-2-(2,4-dichlorophenoxy)aniline

Details on test material:

- Name of test material (as cited in study report): 2',4',4,2-trichloroaminodiphenylether (TADE)
- Physical state: brownish solid
- Analytical purity: 99.32 %
- Lot/batch No.: 9512021
- Stability under test conditions: no data
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Crédo, L'Arbresle, France
- Age at study initiation: approximately eight weeks
- Mean weight at study initiation: 298 ± 14 g for males and 231 ± 15 g for females
- Fasting period before study: no data
- Housing: individually
- Diet (e.g. ad libitum): A04 C pelleted diet (U.A.R., Villemoisson-sur-Orge, France), ad libitum
- Water (e.g. ad libitum): filtered trinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): about 12 cycles / hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure:
- % coverage: 10 % (5 cm x 6 cm for females, 5 x 7 cm for males)
- Type of wrap if used: adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No residual test substance was observed at removal
- Time after start of exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Constant volume or concentration used: yes/no
- For solids, paste formed: yes, hydrophilic gauze pad, pre-moistened with 2 ml of water

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: During the hours following administration of the test substance, the animals were frequently observed for detection of treatment-related clinical signs and mortality. Thereafter, observation was made at least once a day.
Body weight was determined before administartion of the test substance on day 1 and then on days 8 and 15. The body weight gain of the treated animals was compared to a reference curve of CIT control animals with the same initiatial body weight.
- Necropsy of survivors performed: yes, animals were killed on day 15 and a macroscopic examination was performed. After opening the thoracic and abdominal cavities, main organs were examined. In case of macroscopic lesions, organ samples were taken and preserved in 10 % buffered formalin.
No microscopic examination was performed.

Statistics:

No statistics were performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: No mortality

Mortality:

No death occurred during the observation period at 2000 mg/kg.

Clinical signs:

other: No clinical signs were observed during the study. The general behavior of the animals was not affected by treatment with the test substance.

Gross pathology:

No abnormalities were observed at necropsy.

Other findings:

No cutaneous reactions were observed.