4-[2-[4-[benzylmethyl(ethyl)amino]phenyl]vinyl]-1-(2-hydroxyethyl)pyridinium acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October-November 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-[2-[4-[benzylmethyl(ethyl)amino]phenyl]vinyl]-1-(2-hydroxyethyl)pyridinium acetate

EC Number:

281-468-5

EC Name:

4-[2-[4-[benzylmethyl(ethyl)amino]phenyl]vinyl]-1-(2-hydroxyethyl)pyridinium acetate

Cas Number:

83950-14-5

Molecular formula:

C24H27N2O.C2H3O2

IUPAC Name:

4-[2-[4-[benzylmethyl(ethyl)amino]phenyl]vinyl]-1-(2-hydroxyethyl)pyridinium acetate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann Borchen Germany
- Strain: Wistar TNO/W
- Age at study initiation: males 9 weeks. females 14 weeks
- Weight at study initiation: males 157-185 g, females 151-176 g
- Fasting period before study: yes 16 hours pre-dosing and 4 hours post-dosing
- Housing: 5/sex in Macrolon type III cages
- Diet: Altromin R3 1324 (Altromin GmbH Lage, Germany) ad libitum
- Water: tap water ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1.5 °C
- Humidity (%): 60 °C 5 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

0.31, 1.0, 1.25, 1.6, 2.5 and 5.0 mL/kg

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: clinical signs and mortality twice daily
- Body weight: on day 0, 7 and 14
- Necropsy: on all animals

Statistics:

probit analyses

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1.56 mL/kg bw

Based on:

test mat.

95% CL:

>= 1.38 - <= 1.8

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 700 mg/kg bw

Based on:

test mat.

Mortality:

males: 0, 0, 1, 1 ,4 and 5 at 0.31, 1.0, 1.25, 1.6 2.5 and 5.0 mL/kg
females: 0, 0, 2, 3, 5 and 5 at 0.31, 1.0, 1.25, 1.6 2.5 and 5.0 mL/kg
Mortality was within 4 hours after dosing

Clinical signs:

at 1.0 mg/L: nausea in one male and one female
at 1.25 mg/L: diarrhea, nausea and sedation in all animals
at 1.6 and above: diarrhea, nausea, sedation and convulsions in all animals

Body weight:

no data

Gross pathology:

In decedents: orange discoloration prevented examination
in survivors: no findings

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The LD50 in rats is 1700 mg/kg bw

Executive summary:

Rats (5/sex/dose) received a single dose of the substance by gavage ( 0.31, 1.0, 1.25, 1.6, 2.5 and  5.0 mL/kg). Mortality (within 4 hours after dosing) was 0, 0, 3, 4 ,9 and 10 at 0.31, 1.0, 1.25, 1.6, 2.5 and  5.0 mL/kg. During the 14 day observation period diarrhea, nausea, sedation and convulsions were observed in surviving animals. Necropsy of decedents was not possible due to orange discoloration of the organs. In survivors no abnormalities were recorded. The LD50 (as assessed by the author of the report) is 1700 mg/kg bw.