Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted according to internationally accepted testing guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

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:

Rats were dosed at concentrations of 3170, 4640, 6000, 7750 and 10000 mg/kg bw and observed for 14 day post-treatment period in order to evaluated the substance acute oral toxicity.

GLP compliance:

no

Remarks:

Pre GLP.

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate

EC Number:

240-245-2

EC Name:

Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate

Cas Number:

16090-02-1

Molecular formula:

C40H38N12Na2O8S2

IUPAC Name:

disodium 2,2'-ethene-1,2-diylbis{5-[(4-anilino-6-morpholin-4-yl-1,3,5-triazin-2-yl)amino]benzenesulfonate}

Test animals

Species:

rat

Strain:

other: Tif. RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 160 to 180 g.
- Fasting period before study: the rats were starved during one night before starting the treatment.
- Housing: segregated and housed in MacroIon cages (Type 3) in groups of 5.
- Diet: ad libitum, rat food, NAFAG, Gossau SG.
- Health: healtly rats.
- Water: ad libitum.
- Acclimatization: at leas 4 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: approx. 55 ± 5 %.
- Photoperiod: 14 hours light cycle day.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

2%

Details on oral exposure:

TEST SOLUTION
- Preparation: before treatment the suspension was homogeneously dispersed with an Ultra-Turrax.
- During treatment: the suspension was kept stable with a magnetic stirrer.

Doses:

3170, 4640, 6000, 7750 and 10000 mg/kg bw

No. of animals per sex per dose:

20 males and 20 females; 5 x sex x dose.

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes; survivors killed and autopsied after an observation period of 14 days.

Statistics:

LD50 including 95 % confidence limits were calculated by the probit analysis method (Goulden A., Methods of Statistical Analysis, John Wiley and Sons, 1960, 3rd printing, pages 404-408).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

7 562 mg/kg bw

Based on:

test mat.

95% CL:

6 651 - 8 598

Clinical signs:

other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved or ventral position and ruffled fur. The survivor animals recovered within 7 to 8 days.

Gross pathology:

No substance related gross organ changes were seen.

Any other information on results incl. tables

Rate of deaths

Dose mg/kg	Conc. % of formulation	N. of animals		Died within
				1 hr		24 hrs		48 hrs		7 days		14 days
		M	F	M	F	M	F	M	F	M	F	M	F
3170	30	5	5	0	0	0	0	0	0	0	0	0	0
4640	50	5	5	0	0	0	0	1	0	1	0	1	0
6000	50	5	5	0	0	0	1	0	1	0	1	0	1
7750	50	5	5	0	0	3	2	3	2	3	2	3	2
10000	50	5	5	1	2	4	5	4	5	4	5	4	5

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information According to the CLP Regulation. Criteria used for interpretation of results: EU

Conclusions:

LD50: 7562 (95 % CL: 6651-8598) mg/kg bw

Executive summary:

Method

Rats were dosed at concentrations of 3170, 4640, 6000, 7750 and 10000 mg/kg bw and observed for 14 day post-treatment period in order to evaluated the substance acute oral toxicity.

Result

LD50: 7562 (95 % CL: 6651-8598) mg/kg bw.

Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved or ventral position and ruffled fur. The survivor animals recovered within 7 to 8 days.