[4-[[4-(diethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]diethylammonium acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978-10-04 to 1979-01-24

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study but equivalent or similar to OECD Guideline 401 (Acute Oral Toxicity)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

other: 9 doses applied

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

[4-[[4-(diethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]diethylammonium acetate

Cas Number:

76994-37-1

IUPAC Name:

[4-[[4-(diethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]diethylammonium acetate

Test material form:

solid - liquid: suspension

Remarks:

migrated information: dispersion

Details on test material:

- Name of test material: 4,4'-Bis-diethylamino-triphenylmethylium-acetate
- Ratio of test substance to acetic acid = 42 : 58
- Physical state: dispersion in Aqua dest.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: 15-20 h before application
- Diet: ad libitum, fasting started 15-20 h before application (food: HERILAN MRH-HALTUNG; H.EGGERSMANN KG)
- Water: ad libitum, fasting started 15-20 h before application

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle % (w/v): 50, 10, 6.81, 4.64, 3.26, 2.15, 1.47, 1.0, 0.681
- Amount of vehicle: 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw in 10 mL

Doses:

5000, 1000, 681, 464, 316, 215, 147, 100, 68.1 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: weighing after 2-4 days, 7 and 13 days
- Necropsy of survivors performed: yes
- Other examinations performed: body weight

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

206 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Slope factor: 2.73

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

133 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: recalculated based on dye content of registered substance (ca. 65% w/w) versus tested material (42% w/w)

Gross pathology:

In animals that died following observations were made:
The heart showed acute dilatation of the atria and acute passive hyperemia. Fibrinous coatings on the mucosa of the glandular stomach were detected. In some animals lentil-sized areas with considerably thickened, fibrinous coatings with slight adhesion on the side of the serosa were observed. Isolated bloody ulcerations on the mucosa of the glandular stomach were found. The intestines were slightly atonic and contained diarrheal contents. In the lungs moderate acute emphysema was detected.

In animals that were sacrificed after the observation period no organ abnormalities were detected.