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: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Version / remarks:

Adopted February 24, 1987.

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

July 31, 1992.

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

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:

Hanlbm

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, 4414 Füllinsdorf / Switzerland
-Age at study initiation:
males: 8 weeks
females: 11 weeks
-Weight at study initiation:
males: 223.7 - 247.1 g
females: 191.6 - 201.9 g
-Housing: Five in Makrolon type-4 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz). During treatment and observation individually in Makrolon type-3 cages with autoclaved standard softwood bedding.
-Diet: pelleted standard Kliba 343, Batch no. 82/94 rat maintenance diet ("Kliba", Klingentalmuehle 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.)

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
-Area of exposure: ~ 10% of the total body surface
-Type of wrap if used: covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
-Washing: with lukewarm tap water and dried with disposable paper towels.
-Time after start of exposure: 24 hours after the application

TEST MATERIAL
-Application volume/kg body weight: 4 ml/kg

Duration of exposure:

24 hours

Doses:

2000 mg/kg b.w.

No. of animals per sex per dose:

5 per sex per dose

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations:
Mortality / Viability: four times during test day 1 and daily during days 2-15.
Bodyweights: On test days 1, 8 and 15.
Clinical Signs: Clinical Signs Each animal was examined for changes in behaviour and appearance (with special emphasis on the application area, except for the time when the semi-occlusive dressing was in place) four times during day 1, and once daily during days 2-15. All abnormalities were recorded.
- 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/kg 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: Yellow discoloration was observed at the application site after the removal of the dressing until study termination (day 15). In one male animal (no.3) this observation was noted until test day 12.

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:

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

Executive summary:

The substance was tested for acute toxicity by dermal route according to the OECD Guidelines 402 (1987) and the method B.3 of Directive 92/69/EEC. The test substance was administered to a group of 5 male and 5 female rats by dermal application at a single dose of 2000 mg test article/kg body weight. No deaths occurred during the study period. Yellow discoloration was observed at the application site after the removal of the dressing until study termination (14 days after the treatment). However in one male animal this observation was noted until test day 12. There were no test substance-related effects on the body weight of the animals during the observation period. The minimal to slight loss of body weight in one female animals during the first observation week was considered to be a consequence of the semi-occlusive dressing. Commonly female animals prove to be more sensitive in relation to the effects on body weight caused by semi-occlusive dressing than males. The macroscopic examination at study termination revealed no organ abnormalities.

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