Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-[(2-cyanoethyl)[2-(2-hydroxyethoxy)ethyl]amino]-1,3,5-triazine-4,2-diyl]imino]]bis[benzene-1,4-disulphonate]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Remarks:

source of read acorss

Adequacy of study:

key study

Study period:

From March the 17th to April the 07th,1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted on 24 February, 1987

Test guideline 2

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, West-Germany
- Age at start of treatment: ca. 7 weeks
- Body weight at start of treatment: maales 201 - 213 g; females 148 - 175 g
- Identification: earmark- Diet: free access to standard pelleted laboratory animal diet; certificate of analysis has been created.
- Water: free access to tap-water; certificate of analysis has been created.
- Acclimatisation: at least 5 days under laboratory conditions.
- Accomodation: housed in groups of five per sex in polycarbonate cages containing purified sawdust as bedding material.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 7.5 - 15 ACH
- Photoperiod: 12 hours dark / day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

TREATMENT
- Dose volume: 20 ml/kg b.w.
- Dosage preparation: the formulations were prepared immediately prior to dosing. The test substance was weighed into a glass flask on an analytical balance and the vehicle (w/w) was added. Homogeneity of the test substance in vehicle was obtained by a homogeniser.

Doses:

5000 mg/kg b.w.

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of mortality observations: periodic intervals on the day of dosing (day 1) and twice daily thereafter for at least 14 days.
- Frequency of weighing: day 1 (pre-administration), 8 and 15.
- Frequency of symptoms observation: periodic intervals on the day of dosing (day 1) and once daily thereafter (except day 9 and 10).
- Necropsy of survivors performed: yes.

Results and discussion

Effect levels

Sex:

male/female

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

Mortality:

No deaths occured.

Clinical signs:

No clinical signs of toxicity or behavioural.

Body weight:

One female lost 3 grams in the second week; all other animals showed body weight gain during the study period.

Gross pathology:

Macroscopic examination of all animals at termination did not reveal any abnormalities.

Any other information on results incl. tables

Individual animal observations

Sex	Dose level [mg/kg b.w.]	Observations	No. Animals showing effect at exposure time of
			Hours				Day
			0.05	2.1	3.45		2	3	4	5	6	7	8	9	10	11	12	13	14	15
Males	5000	Abnormalities	0	0	0		0	0	0	0	0	0	0	n.a.	n.a.	0	0	0	0	0
		Deaths	0	0	0		0	0	0	0	0	0	0	0	0	0	0	0	0	0
Females	5000	Abnormalities	0	0	0		0	0	0	0	0	0	0	n.a.	n.a.	0	0	0	0	0
		Deaths	0	0	0		0	0	0	0	0	0	0	0	0	0	0	0	0	0
n.a.: inadvertently, no clinical observations performed

Individual body weights

Sex	Dose level [mg/kg b.w.]	Animal no.	Body weight [g] on day			Body weight gain [g] at end
			1	8	15
M	5000	1	206	249	267	67
		2	201	242	258	57
		3	213	275	304	91
		4	208	272	293	85
		5	210	274	302	92
Mean			208	262	285	77
s.d.			4.5	15.7	21	16.9
F	5000	6	173	195	212	39
		7	175	189	195	20
		8	149	168	172	23
		9	151	177	180	29
		10	148	162	159	11
Mean			159	178	184	24
s.d.			13.6	13.8	20.5	10.4

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to CLP Regulation (EC) No 1272/2008

Conclusions:

LD50 (male and female) > 5000 mg/kg b.w.

Executive summary:

The test item was administered to rats of both sexes by oral gavage at 5000 mg/kg body weight, followed by a 15 day observation period. The study was conducted in accordance with the method and procedures outline into the OECD guideline 401.

No mortality occurred during the study period. No clinical signs of toxicity or behavioural changes were seen during the study. Apart from one female that lost 3 grams in the second week, all animals showed body weight gain during the study period.

Macroscopic examination of all animals at termination did not reveal any abnormalities that were considered to have arisen as a result of treatment.

Conclusion

LD50 (male and female) > 5000 mg/kg b.w.