[2-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxoallyl]oxy]ethyl][3-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxoallyl]oxy]propyl]dimethylammonium chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (non-GLP)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

preparation containing CAS 78181-99-4

IUPAC Name:

preparation containing CAS 78181-99-4

Details on test material:

Please refer to confidential details on test material

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: WIGA & Hagemann
- Weight at study initiation: males 150 - 270 g, females 150 - 200 g
- Fasting period before study: 15 h - 20 h before administration
- Diet: Herilan MRH-Haltung; H. Eggersmann KG

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50%, 31.6%, 26.1%, 21.5%, 14.7%, 10.0%

DOSE VOLUME APPLIED:
10 mL/kg bw

Doses:

5000, 3160, 2610, 2150, 1470, 1000 mg/kg bw

No. of animals per sex per dose:

5 rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 700 mg/kg bw

Based on:

test mat.

Remarks on result:

other: interpolated value

Mortality:

The mortality incidences (sexes combined) were:
5000 mg/kg bw: 9/10
3160 mg/kg bw: 10/10
2610 mg/kg bw: 3/10
2150 mg/kg bw: 3/10
1470 mg/kg bw: 1/10
1000 mg/kg bw: 1/10

For details, see table below

Clinical signs:

other: 5000 mg/kg bw: dyspnea, apathy, staggering, twitching, urine yellow, piloerection, exophthalmos, fascicular, twitching, compulsive gnawing, shortness of breath, poor general state 3160 mg/kg bw: dyspnea, apathy, abnormal position, staggering, salivation,

Gross pathology:

Animals that died: heart: acute dilatation; acute passive hyperemia; lungs: slightly edematized; liver: claycolored periphery involving about half of the area of the acinus, confluent in some animals; stomach: extensive bloody ulcerations in the glandular stomach (hemorrhagic corrosive gastritis); intestines: atony, diarrheal contents
Sacrificed animals: nothing abnormal found in the organs

Any other information on results incl. tables

Mortality:

Dose (mg/kg bw)	5000	3160	2610	2150	1470	1000
Males: Number of animals	5	5	5	5	5	5
Dead animals after:
1 h	4	4	2	0	1	0
1 d	5	5	2	0	1	0
2 d	5	5	2	0	1	0
7 d	5	5	2	0	1	0
14 d	5	5	2	0	1	0
Females: Number of animals	5	5	5	5	5	5
Dead animals after:
1 h	3	5	1	1	0	0
1 d	4	5	1	1	0	0
2 d	4	5	1	3	0	1
7 d	4	5	1	3	0	1
14 d	4	5	1	3	0	1

 

Mean weight (g):

Dose (mg/kg bw)		5000	3160	2610	2150	1470	1000
Males: Beginning of test		190	270	190	180	180	150
After	2-4 d			198	203	209	164
	7 d			244	241	241	198
	13 d			282	273	277	213
Females: Beginning of test		170	200	180	150	160	160
After	2-4 d	184		190	171	179	179
	7 d	210		214	187	194	193
	13 d	229		235	198	204	197

 

LD50 determination:

Doses (mg/kg bw)	No. of animals	Dead animals after 14 days	Mortality (%)	Doses used for calculation
1000	10	1	10
1470	10	1	10
2150	10	3	30
2610	10	3	30	*
3160	10	10	100	*
5000	10	9	90
LD50 about 2700 mg/kg bw (interpolated value)

 

Applicant's summary and conclusion

Interpretation of results:

sligthly toxic

Remarks:

Migrated information