2-[2-[4-(diethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan to Apr 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

EG-Richtlinie 84/449 (Amtsblatt der Europaischen Gemeinschaften 27, 1984, L 251, 96)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-[2-[4-(diethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate

EC Number:

264-796-3

EC Name:

2-[2-[4-(diethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate

Cas Number:

64346-30-1

Molecular formula:

C23H29N2.C2H3O2

IUPAC Name:

2-[2-[4-(diethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate

Test material form:

liquid

Details on test material:

Basic Violet 16

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
- Age at study initiation: males: 9 weeks; females: 14 weeks
- Weight at study initiation: males: 185 g; females: 177 g
- Fasting period before study: 16 hours prior to 4 hours after dosing
- Housing: 5 per cage
- Diet (ad libitum): Altromin 1324, ltromin GmbH, Lage, Germany
- Water (ad libitum): tap
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 40 - 60
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 14. Jan to 21. Apr 1986

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: depending on dose level: 10, 20, 30, 40, 50 mL/kg bw
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: the substance is a liquid formulation in aqueous acetic acid

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

100, 200, 300, 400, 500 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:
- clinical signs: Day 1: multiple times
Days 2 to 14: 2/day on weekends and holidays 1/day
- body weight: begin and end of study
- Necropsy of survivors performed: yes; and on all animals that died during the observation period

Statistics:

LD50 calculation; p <= 0.05 according to Rosiello et al., J. Tox. Environ. Health 3, 797, (1977)

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

326 mg/kg bw

Based on:

test mat.

95% CL:

>= 284.6 - <= 375.6

Remarks on result:

other: slope=3.21

Mortality:

mL/kg bw deaths (m/f)
100 0/0
200 0/1 within 1 hour
300 1/2 between 2 and 24 h
400 2/5 between 2 h and 9 days
500 5/5 within 2 hours

Clinical signs:

200 - 500 mg/kg bw: poor general condition, sedation to narcosis, prone/lateral position, reduced growth

no effects at 100 mg/kg bw

Body weight:

reduced gain at 300 and 400 mg/kg bw

Gross pathology:

Unscheduled deaths:
200 - 500 mg/kg: stomach mucosa: folds decreased; internal organs discoloured

Scheduled deaths: no effects

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The LD50 in male and female rats was 326 mg/kg bw. No clinical signs or deaths were observed at 100 mg/kg bw.