2-[[4-[[4-[(4-amino-9,10-dihydro-9,10-dioxo-3-sulpho-1-anthryl)amino]cyclohexyl]amino]-6-fluoro-1,3,5-triazin-2-yl]amino]benzene-1,4-disulphonic acid, potassium sodium salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Dec 1980 - Feb 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

- Principle of test: oral
- Short description of test conditions: media for application: water; 10 rats per sex and dose; observation time: 14 days
- Parameters analysed / observed: intoxication symptoms, mortality

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-[[4-[[4-[(4-amino-9,10-dihydro-9,10-dioxo-3-sulpho-1-anthryl)amino]cyclohexyl]amino]-6-fluoro-1,3,5-triazin-2-yl]amino]benzene-1,4-disulphonic acid, potassium sodium salt

EC Number:

277-179-9

EC Name:

2-[[4-[[4-[(4-amino-9,10-dihydro-9,10-dioxo-3-sulpho-1-anthryl)amino]cyclohexyl]amino]-6-fluoro-1,3,5-triazin-2-yl]amino]benzene-1,4-disulphonic acid, potassium sodium salt

Cas Number:

72987-16-7

Molecular formula:

C29 H26 F N7 O11 S3 . x K . x Na C29H(26-x-y)FK(x)N7Na(y)O11S3

IUPAC Name:

potassium sodium 2-{[4-({4-[(4-amino-9,10-dioxo-3-sulfonato-9,10-dihydroanthracen-1-yl)amino]cyclohexyl}amino)-6-fluoro-1,3,5-triazin-2-yl]amino}benzene-1,4-disulfonate

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Wistar TNO W 74

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: breeder: Winkelmann; Borchen
- Age at study initiation: male: 9 weeks; female: 14 weeks
- Weight at study initiation: male: 162-184g; female: 154-176g
- Fasting period before study: 16 hours before apllication and 4 hours after application
- Housing: Makrolon cage type III (groups of 5 animals)
- Diet (e.g. ad libitum): Altromin R 1324
- Water (e.g. ad libitum): tap water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5°C
- Humidity (%): 60 +/- 5%
- Photoperiod (hrs dark / hrs light): 12h/12h (light from 7 am to 7pm)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20mL/kg

DOSAGE PREPARATION: the test item was solved at ambient temperature in tap water.

Doses:

Male:
3.1 g/kg bw
5.0 g/kg bw

Female:
1.0 g/kg bw
3.1 g/kg bw
4.0 g/kg bw
5.0 g/kg bw
5.8 g/kg bw

No. of animals per sex per dose:

10 animals 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, on a sample basis
- Other examinations performed: clinical signs, body weight

Statistics:

Probit analysis

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

4 710 mg/kg bw

Based on:

test mat.

95% CL:

>= 4 230 - <= 5 200

Mortality:

male: no mortality
female: 2 animals died within 24 hours after application of the dose 4.0 g/kg; 6 animals died within 24 hours after application of the dose 5.0 g/kg; 9 animals died within 24 hours after application of the dose 5.8 g/kg

Clinical signs:

male: dose 5.0g/kg: reduction of general condition, diarrhoea, sedation; symptoms appeared after 1 minute after application, symptoms persist until 3 days after application
female: dose 3.1, 4.0, 5.0 and 5.8 g/kg: reduction of general condition, diarrhoea, sedation, additionally from dose 4.0 g/kg: lateral and abdominal position; symptoms appeared after 1 minute after application, symptoms persist until 3 days after application

Other findings:

- Other observations: No observations during necropsy of organs except intensive discolouration of the organs.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 for oral toxicity to male rats was determined to be > 5000 mg/kg bw.
The LD50 for oral toxicity to female rats was determined to be 4710 mg/kg bw.
The substance is not classifiable according to CLP criteria.