Disodium 4,4'-bis[(4-anilino-6-methoxy-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:

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Principles of method if other than guideline:

No guideline followed, however, the study has been conducted according to generally accepted scientific principles.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

OB 134

IUPAC Name:

OB 134

Test animals

Species:

rat

Strain:

other: Tif RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Initial body weight: 160 - 180 g
- Fasting period before study: overnight
- Housing: in groups of 5 in Macrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 4 days

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

Concentration of formulation: 50 %

Doses:

4640, 7750, 9000 and 10000 mg/kg.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes, for dead animals and for survivors, at the end of the observation period.

Results and discussion

Effect levels

Effect levels 1

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 3 300 mg/kg bw

Based on:

act. ingr.

Effect levels 3

Sex:

not specified

Dose descriptor:

other: LD20

Effect level:

ca. 3 300 mg/kg bw

Based on:

act. ingr.

Mortality:

1 / 5 in the highest dose group.

Clinical signs:

Within 2 hours after treatment, rats in all dosage groups showed sedation, dyspnoea, exophthalamus, curved position and ruffled fur.
The surviving animals recovered within 8 days.
No substance related gross organ changes were noted in dead and killed animals.

Any other information on results incl. tables

dose mg/kg	no. of animals		1 h		24 h		48 h		7 d		14 d
	M	F	M	F	M	F	M	F	M	F	M	F
4640	5	5	0	0	0	0	0	0	0	0	0	0
7750	5	5	0	0	0	0	0	0	0	0	0	0
9000	5	5	0	0	0	0	0	0	0	0	0	0
10000	5	5	0	0	1	1	1	1	1	1	1	1

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 > 10000 mg/kg, corresponding to 3300 mg/kg of a.i.
LD20 = 10000 mg/kg, corresponding to 3300 mg/kg of a.i.

Executive summary:

Method

Acute oral toxicity in rats dosed with 4640, 7750, 9000 and 10000 mg/kg of test material. Rats were observed for effects up to 14 days after dosing.

Results

One rat per sex died at the highest dose of 10000 mg/kg, while no deaths were seen at lower doses. An LD20 = 10000 mg/kg (a.i. 3300 mg/kg) was established, while no LD50 could be determined.