[2-[ethyl[3-methyl-4-[(3-phenyl-1,2,4-thiadiazol-5-yl)azo]phenyl]amino]ethyl]trimethylammonium methyl sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Nov 1982 - Jan 1983

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according 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:

[2-[ethyl[3-methyl-4-[(3-phenyl-1,2,4-thiadiazol-5-yl)azo]phenyl]amino]ethyl]trimethylammonium methyl sulphate

EC Number:

248-957-5

EC Name:

[2-[ethyl[3-methyl-4-[(3-phenyl-1,2,4-thiadiazol-5-yl)azo]phenyl]amino]ethyl]trimethylammonium methyl sulphate

Cas Number:

28313-51-1

Molecular formula:

C22H29N6S.CH3O4S

IUPAC Name:

{2-[ethyl({3-methyl-4-[(E)-2-(3-phenyl-1,2,4-thiadiazol-5-yl)diazen-1-yl]phenyl})amino]ethyl}trimethylazanium methyl sulfate

Test material form:

solid: particulate/powder

Details on test material:

Basic Red 23 Methyl sulfate

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
- Age at study initiation: male: 9 weeks; female: 14 weeks
- Weight at study initiation: male: 164 - 200g; female: 158 - 186g
- Fasting period before study: 16h before until 4h after application
- Housing: 5 animals/ cage (makrolon typ III)
- 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

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20mL/kg bw

Doses:

0.31, 1.00, 1.25, 1.60 and 5.0 g/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: 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 (randomly)
- Other examinations performed: clinical signs, body weight

Statistics:

calculation of LD50 with CI for p<0.05 according to Rosiello et al. J. Tox. Environ. Health, 1977(3):797

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 200 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 100 - <= 1 500

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 008 mg/kg bw

Based on:

act. ingr.

Mortality:

animals died with in 6 days after application

Clinical signs:

1.0 to 5.0 g/kg bw: bad general condition, sedation and growth delay
additionally for male animals from 1.25g/kg bw and for female animals from 1.0 g/kg bw: abdominal and lateral position
symptoms occurred 1 hour after application and disappeared at the latest after 8 days
no clinical signs in the lowest dose of 0.31 g/kg bw

Body weight:

retarded growth between 1 and 5 g/kg bw

Gross pathology:

in died animals of doses 1.0 to 5.0 g/kg bw: stomach with partly massive mucosal bleeding

Any other information on results incl. tables

Results for male and female animals

dose [g/kg bw)	toxicological results			duration of symptoms	time of death	mortality [%]
	died animals	animals with symptoms	treated animals
0.31	0	0	10	-	-	0
1.00	1	10	10	1h - 8d	3d	10
1.25	4	10	10	1h - 8d	5d - 6d	40
1.60	9	10	10	1h - 8d	2d - 6d	90
5.00	10	10	10	1h - 3d	24h - 3d	100

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The LD50 of the test substance for acute oral toxicity to female rats was calculated to be 1200 mg/kg bw.