Disodium 4,4'-bis[[6-anilino-4-[(2-hydroxyethyl)methylamino]-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: Test procedures are well documented and scientifically acceptable.

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:

The acute oral LD50 of the test substance in rats of both sexes was tested administrating the test item by gavage at doses of 6000, 7750 and 10000 mg/kg bw; the animals were observed over a period of 14 days.

GLP compliance:

not specified

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[[6-anilino-4-[(2-hydroxyethyl)methylamino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate

EC Number:

237-600-9

EC Name:

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

Cas Number:

13863-31-5

Molecular formula:

C38H40N12Na2O8S2

IUPAC Name:

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

Test animals

Species:

rat

Strain:

other: Tif RAIf

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: testing laboratory.
- Weight at study initiation: 160 to 180 grams.
- Fasting period before study: animal fasted overnight.
- Housing: housed in group of 5 in Macrolon cages (type 3).
- Diet: ad libitum, rat food NAFAG, Gossau SG.
- Water: ad libitum.
- Acclimation period: for a minimum of 4 days.

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2 %
- Preparation of the solution: the suspension was homogeneously dispersed with Ultra-Turrax and during it was kept stable with magnetic stirred.

Doses:

6000, 7750, 10000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females per dose.

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

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

Gross pathology:

No substance related gross organ changes were seen.

Any other information on results incl. tables

Rate of deaths

Dose mag/kg	Conc. % of formulation	N. of animals		Died within
				1 h		24 hrs		48 hrs		7 days		14 days
		F	M	F	M	F	M	F	M	F	M	F	M
6000	50	5	5	0	0	0	0	0	0	0	0	0	0
7750	50	5	5	0	0	0	0	0	0	0	0	0	0
10000	50	5	5	0	0	0	0	0	0	0	0	0	0

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 > 10000 mg/kg bw

Executive summary:

Method

The acute oral LD50 of the substance in rats of both sexes was tested administrating the test item by gavage at doses of 6000, 7750 and 10000 mg/kg bw; the animals were observed over a period of 14 days.

Results

No deaths occurred. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. The animals recovered within 8 days.

LD50 > 10000 mg/kg bw