3-(2,4-bis(4-((5-(4,6-bis(2-aminopropylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-disulfonaphthalen-3-yl)azo)phenylamino)-1,3,5-triazin-6-ylamino)propyldiethylammonium lactate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From April 10th to May 1st, 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

July 31st, 1992

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

February 24th, 1987

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-(2,4-bis(4-((5-(4,6-bis(2-aminopropylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-disulfonaphthalen-3-yl)azo)phenylamino)-1,3,5-triazin-6-ylamino)propyldiethylammonium lactate

EC Number:

424-310-4

EC Name:

3-(2,4-bis(4-((5-(4,6-bis(2-aminopropylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-disulfonaphthalen-3-yl)azo)phenylamino)-1,3,5-triazin-6-ylamino)propyldiethylammonium lactate

Cas Number:

178452-66-9

Molecular formula:

Hill formula: C63 H83 N27 O17 S4 CAS formula: C60 H77 N27 O14 S4 . C3 H6 O3

IUPAC Name:

2-hydroxypropanoic acid; 5-({4,6-bis[(2-aminopropyl)amino]-1,3,5-triazin-2-yl}amino)-3-{2-[4-({4-[(4-{2-[8-({4,6-bis[(2-aminopropyl)amino]-1,3,5-triazin-2-yl}amino)-1-hydroxy-3,6-disulfonaphthalen-2-yl]diazen-1-yl}phenyl)amino]-6-{[3-(diethylamino)propyl]amino}-1,3,5-triazin-2-yl}amino)phenyl]diazen-1-yl}-4-hydroxynaphthalene-2,7-disulfonic acid

Test material form:

solid

Specific details on test material used for the study:

Stable in a 1:1 mixture of PEG/water for 48 hours

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: bidistilled water:PEG 400 = 1:1

Details on oral exposure:

Dosage after 16 hours fasting, but free access to water. Food was provided approximately 3 hours after dosing.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male rats, 5 female rats

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

There were no deaths as a result of treatment with the test substance.

Clinical signs:

other: No clinical signs of toxicity were observed during the observation period.

Gross pathology:

No macroscopic findings were observed at necrospy.

Any other information on results incl. tables

The mean lethal dose of the test substance after single oral administration to rats of both sexes, observed for a period of 14 days, could not be estimated because LD50 > 2000 mg/Kg.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

LD50 > 2000 mg/kg

Executive summary:

The acute toxicity of the test material was investigated following oral administration of a single dose to the rat, according to the OECD Guideline 401.

The test substance was administered to rats of both sexes by oral gavage, at a dose of 2000 mg/kg.
The following death rate was observed:
0% at 0 mg/kg (control group)
0% at 2000 mg/kg

No clinical signs of toxicity were observed during the observation period.

The acute oral LD50 of the test substance in rats of both sexes, observed over a period of 14 days, was estimated to be greater than 2000 mg/kg.