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: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From April 30th to May 21st, 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:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

February 24th, 1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

July 31st, 1992

GLP compliance:

yes (incl. QA statement)

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

Type of coverage:

semiocclusive

Vehicle:

other: other: bidistilled water:PEG 400 = 1:1

Details on dermal exposure:

Clipped area on the back of animals corresponding to ca. 10 % of the total body surface.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male rats, 5 female rats

Control animals:

no

Details on study design:

Observations up to day 15.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death occurred.

Clinical signs:

other: There were no clinical signs of sistemic toxicity.

Gross pathology:

No macroscopic findings were noted at necropsy.

Other findings:

After removal of the dressing on test day 2, a blue coloration of the skin was observed at the application site of all animals. The staining persisted until test day 7.

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 dermal administration of a single dose to the rat, according to the OECD Guideline 402. A single dose of 2000 mg/kg was administered to a group of 5 male and 5 female animals for 24 hours, under semiocclusive dressing. Animals were observed up to day 15. After 14 days, all animals were killed and subjected to necropsy examination.

No mortality occurred and no signs of toxicity were observed in male or female animals during the observation period. No significant abnormalities were found at necropsy in the animals at termination of the study.

LD50 > 2000 mg/kg