2-[2-[4-[(2-cyanoethyl)methylamino]phenyl]vinyl]-1,3,3-trimethyl-3H-indolium dihydrogen phosphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from January to May, 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Principles of method if other than guideline:

Not specified.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Basic Red 014 phosphate

IUPAC Name:

Basic Red 014 phosphate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 9 - 14 weeks of age.
- Weight at study initiation: 155 - 191 g (males), 152 - 189 m (females).
- Housing: 5 per cage.
- Diet: pellet suspended from 16 h before to 4 h post exposure.
- Water: ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 0.5 °C.
- Humidity: 60 ± 5 %.
- Photoperiod: 12 hrs dark / 12 hrs light.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

1000, 2000, 2500, 3100, 5000 mg/kg bw.

No. of animals per sex per dose:

5 animal/sex/dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations: twice daily.
- Other examinations performed: clinical signs (position, sedation, diarrhoea); histopathological examination of dead animals.

Statistics:

LD50 value with p lower than 0.05 computed based on Rosiello et al., J. Tox. Environ. Health 3, 1977, 797.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 400 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 600 mg/kg bw

Based on:

act. ingr.

Mortality:

Mortality occurred within 2 hours from administration.

Clinical signs:

Symptoms, as reduction of general conditions, sedation and diarrhoea, were evident starting from 10 minutes up to 3 days after administration.

Gross pathology:

Stomach and intestines of dead animals dosed from 2000 to 5000 mg/kg bw could not be evaluated due to discoloration.
The other organs at dosages 1000-3100 mg / kg showed no compound-related changes.

Any other information on results incl. tables

Results in female rats

doses mg/kg	no. animals	no. dead animals	no. animals with symptoms	time of death	duration of symptoms
1000	5	0	0
2000	5	1	5	2 h	10 min to 3 d
2500	5	3	5	2 h	10 min to 3 d
3100	5	5	5	2 h	10 min to 3 d
5000	5	5	5	1h 1/2	10 min to 3 d

Results in male rats

doses mg/kg	no. animals	no. dead animals	no. animals with symptoms	time of death	duration of symptoms
1000	5	0	0
2000	5	0	5		10 min to 3 d
2500	5	2	5	2 h	10 min to 3 d
3100	5	4	5	1 h 1/2	10 min to 3 d
5000	5	5	5	1h 1/2	10 min to 3 d

Overall mortality

doses mg/kg	no. animals	mortality %
1000	10	0
2000	10	10
2500	10	50
3100	10	90
5000	10	100

Applicant's summary and conclusion

Interpretation of results:

other: Category 4 based on CLP criteria

Conclusions:

Acute oral exposure of rats to the substance lead to LD50 = 2400 mg/kg bw, equivalent to ca. 1600 mg/kg bw as active ingredient. Higher toxicity in female than in male rats was noted.

Executive summary:

Method

Acute oral toxicity by gavage in both male and female rats with a 14-day observation period.

Results

LD50 of 2400 mg/kg for both male and female rats, equivalent to ca. 1600 mg/kg bw of active ingredient for the given purity of test material. Female rats showed higher sensitivity than males to the substance. Mortality occurred within 2 hours from administration. At necropsy, stomach and intestines of dead animals dosed from 2000 to 5000 mg/kg bw could not be evaluated due to discoloration; the other organs at dosages 1000 - 3100 mg / kg bw showed no compound-related effects.