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

Endpoint summary

Description of key information

The oral LD50 was 206 mg/kg bw in rats after an observation period of 14 days. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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)

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

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

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

Sex:

male/female

Dose descriptor:

LD50

Effect level:

206 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Slope factor: 2.73

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

206 mg/kg bw

Additional information

For acute oral toxicity via oral route an experimental study with the test substance was performed (BASF AG, 1979). It was conducted similar to OECD Guideline 401.

The test substance was given to Sprague-Dawley rats. For each dose 5 animals of each sex were treated once and observed for 14 days. The test substance was administered orally by gavage. Nine different doses were tested. After 14 days an LD50 of 206 mg/kg bw was found. Animals that died during the observation period showed a number of alterations in heart, stomach, intestines and lungs. Those included among others acute dilatation of the atria, acute passive hyperemia, fibrinous coatings and isolated bloody ulcerations on the mucosa of the glandular stomach, diarrheal contents and slightly atonic intestines and a moderate acute emphysema in the lung. Animals that survived and were sacrificed after the observation period showed no pathological changes in organs. With regard to the actual test item composition the median lethal dose was recalculated to 133 mg/kg body weight.

Justification for selection of acute toxicity – oral endpoint
Non GLP study but performed equivalent to guideline.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance needs to be classified and labelled as acute tox. cat. 3, H301 "Toxic if swallowed" under Regulation (EC) No 1272/2008, as amended for the sixth time in Directive EC 605/2014