2-[2-(2,3-dihydro-2-methyl-1H-indol-1-yl)vinyl]-1,3,3-trimethyl-3H-indolium chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-05-08 to 1990-05-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-[2-(2,3-dihydro-2-methyl-1H-indol-1-yl)vinyl]-1,3,3-trimethyl-3H-indolium chloride

EC Number:

228-800-7

EC Name:

2-[2-(2,3-dihydro-2-methyl-1H-indol-1-yl)vinyl]-1,3,3-trimethyl-3H-indolium chloride

Cas Number:

6359-50-8

Molecular formula:

C22H25N2.Cl

IUPAC Name:

2-[2-(2,3-dihydro-2-methyl-1H-indol-1-yl)vinyl]-1,3,3-trimethyl-3H-indolium chloride

Test material form:

solid: particulate/powder

Details on test material:

Basic Yellow 21

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Bor: WISW (SPF Cpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: male: 8 weeks, female: 10 weeks
- Weight at study initiation: average male: 177g female: 171g
- Fasting period before study: 16h before and 4h after application fasting
- Housing: Makrolon cage Type III, 5 animals per cage
- Diet (e.g. ad libitum): Altromin 1324 ad libitum
- Water (e.g. ad libitum): mains water ad libitum
- Acclimation period: at least 4 days acclimation

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 50 +/- 10%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

DOSAGE PREPARATION: the test substanc was mixed in mains water at ambient temperature

VEHICLE
- Concentration in vehicle: 5, 10, 20 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: good water solubility


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

50, 100 and 200 mg/kg bw based on preliminary study

No. of animals per sex per dose:

5 per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day of application: multiple observations; during 14 days observation: twice per working day, once on weekend and holiday; weekly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

LD50 calculation based on "moving averages" according to Spearman and Kärber.
In case of dose levels with 0 and 100% mortality determination of geometric mean as "approximative" LD50

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

162 mg/kg bw

Based on:

test mat.

95% CL:

106 - 250

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

140 mg/kg bw

Based on:

act. ingr.

Mortality:

one and three rats/sex died at 100 and 200 mg/kg bw, respectively - see table below

Clinical signs:

100 and 200 mg/kg bw: bad general condition, sedation and prone position
100 mg/kg bw: piloerection in one male and one female animal
clinical signs occured 15 minutes after application and disappeared at the latest after 2 days
no clinical signs in the lowest dose of 50 mg/kg bw

Body weight:

not affected

Gross pathology:

died animals: affected stomach mucosa, fundus of the stomach and intestine reddened and tumid
survived animals: no findings

Any other information on results incl. tables

dose [mg/kg bw]	animals treated/ animals died	time of death	mortality [%]
	male
50.0	0/5	-	0
100.0	1/5	2d	20
200.0	3/5	1-4h	60
	female
50.0	0/5	-	0
100.0	1/5	1h	20
200.0	3/5	1-4h	60

dose [mg/kg bw]	average body weight [g]
	male
	week 0	week 1	week 2
50.0	183	225	253
100.0	174	222	250
200.0	175	218	242
	female
	week 0	week 1	week 2
50.0	177	189	192
100.0	164	184	193
200.0	173	196	202

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The LD50 (oral, gavage) of the test substance for acute toxicity to male and female rats was calculated to be 162 mg/kg bw. The substance is classified as Category 3.