Pentasodium bis{7-[4-(1-butyl-5-cyano-1,2-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridylazo)phenylsulfonylamino]-5'-nitro-3,3'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato} chromate (III)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

Adopted February 24, 1987.

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

July 31, 1992

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pentasodium bis{7-[4-(1-butyl-5-cyano-1,2-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridylazo)phenylsulfonylamino]-5'-nitro-3,3'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato} chromate (III)

EC Number:

419-210-2

EC Name:

Pentasodium bis{7-[4-(1-butyl-5-cyano-1,2-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridylazo)phenylsulfonylamino]-5'-nitro-3,3'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato} chromate (III)

Cas Number:

178452-71-6

Molecular formula:

C66H48CrN16Na5O28S6

IUPAC Name:

chromium(3+) pentasodium bis(7-{4-[2-(1-butyl-5-cyano-2-hydroxy-4-methyl-6-oxo-1,6-dihydropyridin-3-yl)diazen-1-yl]benzenesulfonamido}-2-[2-(5-nitro-2-oxido-3-sulfonatophenyl)diazen-1-yl]-3-sulfonatonaphthalen-1-olate)

Test animals

Species:

rat

Strain:

Wistar

Remarks:

HanIbm

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: BRL, Biological Research Laboratories Ltd. Wólferstrasse 4, 4414 Füllinsdorf / Switzerland
-Age at study initiation:
males: 8 weeks
females: 10 weeks
-Weight at study initiation:
males: 197.4 - 207.4 g
females: 177.4 - 182.6 g
-Fasting period before study: overnight fasting period prior to application
-Housing: Groups of five in Makrolon type-4 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
-Diet: Pelleted standard Kliba 343, Batch no. 82/94 rat maintenance diet ("Kliba", Klingentalmueble AG, CH-4303 Kaiseraugst) available ad libitum
-Water: Community tap water from Füllinsdorf, available ad libitum.
-Acclimation period: one week

ENVIRONMENTAL CONDITIONS
-Temperature: 19 - 20.5 °C
-Humidity: 46 - 62 %
-Air changes: 10-15 air changes per hour
-Photoperiod: 12 hours artificial fluorescent light (approx, 100 Lux) / 12 hours dark (light period between 6.00 a.m. to 6.00 p.m.)
-Other: music during the light period

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

bi-distilled

Details on oral exposure:

VEHICLE
-Application volume/kg body weight: 10 ml/kg

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5 per sex per dose

Control animals:

no

Details on study design:

-Duration of observation period following administration: 14 days
-Frequency of observations: each animal was examined for changes in appearance and behaviour four times during day 1, and once daily during days 2-15. All abnormalities were recorded.
-Frequency of observations of Mortality / Viability: Four times during test day 1 and daily during days 2-15.
-Frequency of weighing: On test day 1 (pre-administration), 8 and 15.
-Necropsy of survivors performed: yes
Necropsies were performed by experienced prosectors. At the end of the observation period all animals were anesthetized by intraperitoneal injection of Narcoren at a dose of at least 2.0 ml/kg body weight (equivalent to at least 320 mg sodium pentobarbitone/kg body weight) and sacrificed by exsanguination. The animals were examined macroscopically and all abnormalities recorded.

Statistics:

The LOGIT-Model could not be used as no deaths occurred.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

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

Clinical signs:

other: The only clinical sign observed during the observation period was diarrhea in all animals.

Gross pathology:

No organ abnormalities were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The LD50 (rat) was found to be greater than 2000 mg/kg body weight.

Executive summary:

The substance was tested for acute administration by oral route according to the OECD Guideline 401 (1987) and the EU method B.1 of the Directive 92/69/EEC. The test substance was administered to a group of 5 male and 5 female rats by oral gavage, at a single dose of 2000 mg test article/kg body weight. There were no deaths as a result of treatment with the test substance. The clinical sign noted during the observation period (14 days after the treatment) was diarrhoea in all animals. No other clinical signs were observed. There was no effect on body weight gain during the observation period. No organ abnormalities were observed at necropsy.

The LD50 (rat, oral) was found to be greater than 2000 mg/kg body weight.