1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium methyl sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Oct - Dec 1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

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:

1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium methyl sulphate

EC Number:

277-232-6

EC Name:

1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium methyl sulphate

Cas Number:

73019-09-7

Molecular formula:

C20H24N3.CH3O4S

IUPAC Name:

1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium methyl sulphate

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Remarks:

WISW (SPF CPB)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann (Borchen)
- Age at study initiation: male: 9 weeks; female 14 weeks
- Weight at study initiation: male: 166 - 201g; female: 153 - 179g
- Fasting period before study: 16h befor until 4 hours after application
- Housing: Makroloncage Type III in groups of 5
- Diet (e.g. ad libitum): Altromin R 1324, ad libitum
- Water (e.g. ad libitum): mains water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 1.5°C
- Humidity (%): 60 +/- 5%
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

100, 310, 400, 500, 630 mg/kg

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: day of application: multiple observations; during 3 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

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

396 mg/kg bw

Based on:

test mat.

95% CL:

> 350 - < 441

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

143 mg/kg bw

Based on:

act. ingr.

Mortality:

all motality occured with in 24h after application, details see Table 1.

Clinical signs:

clinical signes occured 1 minute after application until 3 days after application:
- 310 to 630 mg/kg bw: worse general condition, nausea and sedation
- additionally male from 400 mg/kg bw and female from 310 mg/kg bw: abdominal/lateral position

Body weight:

No effect

Gross pathology:

Male and female animals from dose 310 to 630 mg/kg bw with coloured stomach and small intestine wall. Additionally: stomach without mucosal fold.

Other findings:

No significant difference between male and female animals.

Any other information on results incl. tables

Table 1: results

dose [mg/kg bw]	sex	animals			dead after
		dead	symptomatical	treated
100	m	0	0	5	-
310	m	0	5	5	-
400	m	3	5	5	1h
500	m	4	5	5	1 - 24h
630	m	5	5	5	1h
100	f	0	0	5	-
310	f	1	5	5	24h
400	f	2	5	5	1h
500	f	5	5	5	1h - 24h
630	f	5	5	5	1h

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The acute LD50 (oral) to male and female rats was calculated to be 396 mg/kg bw under the conditions of the test. Based on the active ingredient, the LD50 is 143 mg/kg bw. The test substance is classified as Category 3 according to CLP criteria.